Hessen – Your Gateway to the Diagnostics Market in Europe · in vitro diagnostics in Hessen:...

Hessian Ministry of Economics, Transport, Urban and Regional Development

Hessen – Your Gateway to the Diagnostics Market in Europe

A Practical Guide to Services and Technology for the Diagnostic Industry

www.hessen-biotech.de

Imprint

PublisherHessian Ministry of Economics, Transport,

Urban and Regional Development

Project ManagementHessen-Biotech

Dr. Detlef Terzenbach

HA Hessen Agentur GmbH

Abraham-Lincoln-Str. 38-42

65189 Wiesbaden / Germany

T: +49 611 7748 613

F: +49 611 7748 620

[email protected]


Editorial OfficeGenius GmbH, Darmstadt

www.genius.de

Layoutansicht kommunikationsagentur

www.ansicht.com

PrintWerbedruck Schreckhase, Spangenberg

DisclaimerListing of a company profile within this publication is

strictly voluntary, all Companies doing business in the

field of in vitro diagnostics have the opportunity of being

entered in this database.

Fotographs committed byAbbott Diagnostics (pp 23-25)

BIT Analytical Instruments (pp 20-22)

Klaus Treude (pp 5-9)

Paul-Ehrlich-Institute (pp 13-18)

Philipps-University (pp 16-17)

Sysmex (pp 10-12)

targos (pp 18-19)

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Content

in vitro diagnostics in Hessen:Interdisciplinary and Attuned to Innovation 4

in vitro diagnostics in Hessen 5-9

in vitro diagnostics – a Future-Oriented Market in Movement 10-12

Regulatory View of in vitro diagnostics 13-15

Basis for Optimal Patient Care: Laboratory Diagnostics in Clinical Practise 16-17

Predicting the Response to the High-Value Medicines of Tomorrow 18-19

Efficiency through Integration: Development of Diagnostic Platforms 20-22

Bringing New Ideas into Life with a Big Partner 23-25

Company Profiles 26-42

in vitro diagnostics in Hessen:Interdisciplinary and Attuned to Innovation

Prevention is better than cure. This is true not onlyfor the benefit of patients and physicians but alsofor the healthcare system at large. A precise dia-gnosis at a very early stage greatly enhances thechances of curing or even preventing an upcomingdisease and thereby reduces the costs to the health -care system significantly. In this context, in vitro diagnostic (ivd) methods play a crucial role. Usingthese modern assays, diseases can be detectedeven in their earliest stages. Furthermore, in vitrodiagnosis makes it possible to gain information onthe cause of disease, the effect of medical treat-ment and the overall healing process. Although laboratory diagnostics account for only 2–3% of thetotal healthcare expenditures in Europe, they represent a large saving in the cost for treatments.

Being the starting point of every medical treatment,innovation in diagnostics leads to innovationthroughout the whole healthcare system. More pre-cise, personalised and differentiated results opennew ways of treatment for physicians and new tar-gets for the pharmaceutical industry. The completehealthcare system therefore profits from diagnosticinnovation. Driven by the insight of being a main-stay for the healthcare system, the diagnosticbranch today is one of the most innovative industries.

Much of this innovation comes from Hessen, wheremany large, medium-sized and small diagnosticcompanies flourish in the productive environmentof research-driven medtech, biotech, nanotech andIT companies and device manufacturers, to nameonly a few. Hessen offers a diverse life science land-scape and thus represents a rich hotbed for in vitrodiagnostics. Not least due to its long tradition as alocation for chemistry and pharmaceuticals, a livelybiotechnology and medical technology scene hasevolved here.

Another important feature of Hessen: The regionoffers a dense network of universities, universitiesof applied sciences and other research institutes,covering the complete spectrum of life sciences.

Companies seeking access to the European ivdmarket will find a perfect base in Hessen.

This brochure allows easy access to partners intechnology, services and products. Therefore, I invite everyone to make use of the extraordinaryopportunities of Hessen as a starting point for ivdbusiness.

Dr. Alois Rhiel

Hessian State Minister of Economics, Transport, Urban and Regional Development

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This brochure presents the first comprehensiveanalysis of the in vitro diagnostics (ivd) industryin Hessen. Targeted surveys, intensive databaseresearch and comparison with national and in-ternational information on this sector have pro-vided a reliable basis for the assessment of theivd sector in Hessen. Complemented with con-tributions from Hessian experts in this field, thispublication gives in-depth information on current market trends and ground-breakingtechnologies in ivd. The company profiles of the local ivd companies make this brochure acomprehensive reference guide for anyone interested in this emerging industry.

Hessen – The Gateway to the European Diagnostics Market

Hessen is a dynamic site for the ivd sector: Already 54 diagnostics companies are basedhere. In Hessen, these currently provide work foraround 6,000 employees, of whom approxima-tely 5,000 (83%) are employed directly in the ivdindustry. Last year these Hessian companiesachieved a total turnover of roughly 1.5 billionEuros. Of this, around 1.2 billion Euros (80%)was allotted straight to ivd. The significance ofthese figures emerges in the international com-parison: For 2006, the German Diagnostics In-dustry Association (Verband der Diagnostika-Industrie, VDGH) estimated a worldwide totalturnover of 30 billion Euros in the field of ivdand the latest figures of the European umbrellaorganisation (European Diagnostic Manufactu-rers Association, EDMA, 2006) amount to 9.2 billion Euros for the European ivd market.

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Interdisciplinary and Geared to Innovation

As a classical cross-section discipline, modern invitro diagnostics (ivd) profit from the rapid ad-vances in biotechnology, molecular biology, information and medical technology. Thus, ivdswill undoubtedly become a leading sector withinthe healthcare system in the coming years. In2006, the worldwide market for reagents, test systems, analytical equipment and services com-prised around 30 billion Euros with an averagegrowth of 7% per year. Europe has the secondlargest share, after North America, in the interna-tional ivd market, with Germany being the mar-ket leader in the European comparison.

in vitro diagnostics in Hessen

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Annual total turnover of ivd companies in Hessen

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The geographical distribution of ivd companies in Hessen shows a

high density in the southern regions.

A Mix of Regional SMEs and International Players

Of the 54 diagnostics companies, 36 (67%) are dy-namic, highly innovative small and medium-sizedenterprises (SMEs) and form the basis of the Hes-sian ivd industry. In general, these specialise in ivd,meaning that they achieve more than half of theirtotal turnover with products and services in andaround ivds. There are also the large and very largecompanies with headquarters in Hessen and glo-bal companies that have a branch in Hessen. With1,700 employees Abbott is the largest ivd Com-pany in Hessen. Abbott operates its entire dia -gnostics business for Europe, the Middle East andAfrica from Wiesbaden, running large develop-ment and production facilities there. Anothermajor player in this location is Siemens HealthcareDiagnostics, which – through the acquisition ofDade Behring, DPC Biermann and Bayer Diagnos-tics – has become one of the most important com-petitors in the European ivd market next to Abbott,Roche Diagnostics and Beckman Coulter. According to a Study by Frost & Sullivan from2005, these companies have a turnover represent-ing 60% of the European market.

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A Center for the Diagnostic Industry

A distinct North-South-divide is apparent in theHessian ivd landscape. The most active region inthe business sector is southern Hessen, wheremore than 70% of all Hessian ivd companies are located, amongst which are the global players: Abbott, Biotest and Siemens Healthcare Diagnos-tics with several locations. Approximately 20% ofthe ivd companies are found in central Hessen. Inaddition to the Siemens subsidiary Dade Behringin Marburg, there are mainly small and medium-sized companies in the Giessen area. Only a fewivd companies are based in northern Hessen.

Innovative and Interdisciplinary

The entire value chain of the ivd industry – R&D,production and distribution – is represented inHessen. Research is of high importance here. Ofthe companies questioned, 74% carry out R&D,in Hessen, and another 13% facilitates R&D out-side of Hessen. This is a sign of the strength ofinnovation in Hessen. This impression is con -firmed by the fact that a third of all companies undertaking research invest more than 10% oftheir turnover in R&D; a further 5% even morethan 50%.

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R&D locations R&D share in the total turnover

Laboratory Diagnostics in Focus – Focal Point Immune Diagnostics

Within the product segments, the focus is clearlyon laboratory diagnostics. More than 90% of theivd companies work in this field; just under 40%are concerned with user-friendly Point of Care(POC) and rapid testing.

Immune diagnostics play an important role. Morethan 60% of the Hessian ivd-companies offer pro-ducts and services in this segment. Another Hes-sian strength ist the field of molecular diagnostics,which encompasses the development of biomar-kers. 26% of the ivd-companies in Hessen work inthis innovative area.

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Hessen: Germany’s economic powerhouse

Among the 16 German States, Hessen is one of

the most successful regions. Most of all, it has a

long standing tradition as a center of the che-

mical and pharmaceutical industry, which is the

largest industrial sector employing more than

86.000.

Hessen is home to Companies like EMD Se-

rono, Fresenius, B. Braun, Siemens Diagnostics,

Merz and Biotest, to name only a few. Global

Players like Sanofi-Aventis, Novartis, Abbott,

Clariant and Evonik run major parts of their

businesses in Hessen.

Frankfurt is home to Continental Europes

largest Airport and to the European Central

Bank.

Population: 6.1 m

Capitol: Wiesbaden (271,000)

Largest City: Frankfurt (655,000)

GDP per Capita: € 33.614

Information: www.invest-in-hessen.com

8 in vitro diagnostics in Hessen

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So the infant molecular diagnostics have gained anequal importance like the already established ap-plication fields – clinical chemistry, microbiology/bacteriology, haematology/ histology/cytology –ranging between 25% and 29%.

Highest Marks for Infrastructure and Expertise

What is it that makes the location Hessen so attrac-tive to companies? This was also part of the survey,and the results show 80% of the interviewed com-panies are satisfied or highly satisfied with the localconditions in Hessen.

Participants in the survey praised the outstandingtraffic infrastructure, which was also rated as verygood in an international context. In second andthird place were the proximity to clinics and re-search facilities and the availability of skilled per-sonnel. Here, the especially tight net of universitiesand research establishments in the field of life sciences and the good connection via the hubFrankfurt – Europe’s turnstile – pay off.

Definition of ivd Companies

As the ivd industry does not officially represent anindependent industrial sector, a definition was firstdecided upon to identify the ivd companies in Hes-sen. These are involved with products and servicesin and around the medical analysis of body fluidsand tissues outside of the body (i.e. in vitro). Thespecific requirements of an ivd company areshown in the following box.

IVD Definition

• Lat. in vitro: in a test tube (Analyses of body

fluids and tissue sections outside of the body).

• Laboratory diagnostics

• Point of Care Testing (POC)

• Rapid Testing

Definition: IVD Company

According to the German Diagnostics Industry

Association (Verband der Diagnostika-Industrie,

VDGH) and European Diagnostic Manufacturers

Association (EDMA):

Suppliers of reagents, analytical equipment,

consumable materials or software for the use

in areas of IVD:

• Clinical Chemistry,

• Immune Chemistry,

• Microbiology/Bacteriology,

• Haematology/Histology/Cytology,

• Infectious Immunology or

• Molecular Biology

in vitro diagnostics – a Future-Oriented Market in MovementJürgen Schulze, German Diagnostics Industry Association

10 in vitro diagnostics – A future-oriented market in movement

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Sales of in vitro diagnostic (ivd) products in Europehave been recently increasing by about 3–6% peryear. This increase varies depending on the statusof the healthcare system with respect to develop-ment and the corresponding regulatory activitieswithin the European countries. There is a high de-mand for ivd products in the new member states ofthe EU; however, recent increments in turnoversales in Germany have been between 0 and 3% peryear, showing restained growth. In 2007, the Ger-man diagnostics industry had a 2053.5 million Euroturnover for ivd products, an increase of 2% com-pared with 2006. The market for innovative pro-ducts such as molecular diagnostic applications isdeveloping, although that for routine diagnosticscurrently shows no expansion.

Early Recognition, Timely Treatment

Laboratory diagnoses are often only seen as an expense factor. In actual fact, laboratory expensesamount to 3.35 billion Euro, which represents only2.2% of the total expenditure of the compulsoryhealth insurance fund. Compared with the minorportion of cost, the significance of modern labora-tory diagnostics for the healthcare system is im-mense.

Almost two thirds of all clinical diagnoses arebased on laboratory analysis. Laboratory dia-gnostics make early recognition of disease and a timely treatment possible. Multifaceted testsimprove the diagnosis, and eliminate differentialdiagnoses, so aiding prognosis and therapeuticmeasures. In this way, tests that often only cost afew cents or euros help to im prove the quality oflife of the patient and to achieve cost savings forthe overall healthcare system.

The German Diagnostics Industry Association(VDGH) is actively campaigning to show the bene-fits of modern laboratory diagnostics as a triggerfor medical progress, demonstrating the savingsfor the overall system and the economical poten-tial of this industrial sector. The VDGH is advoca-ting an overall strategy for economical, technolo -gical and healthcare politics to use the potential of diagnostics development both for employmentwithin the healthcare system and for the benefit ofour economy.

In 2007, only 2,2 % (3.35 bn €) of the total expenditure of the Ger-

man statutory health insurance funds (totalling € 153.62 billion)

went into laboratory tests (source: VDGH, www.vdgh.de).

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Chances for an Improved Prevention

Laboratory diagnostics are of great significance inthe area of prevention. Tumors that are identifiedat an early stage (such as prostate, cervical or bladder cancer) can be treated successfully. Earlyrecognition of coronary heart disease can also contribute to successful therapy.

The diagnostic industry provides innovative pro-ducts for early diagnosis for various diseases. Totake advantage of this progress, it is important thatpatients use the paid healthcare prevention pro-grams of the compulsory healthcare providers, andthat the healthcare systems take these innovativetests into the program they offer. As an example,colon cancer, if detected early enough, is curablein almost all cases. Yearly more than 70,000 peopleare diagnosed with colon cancer; the number ofdeaths is around 30,000. Only about 12% of qua-lified patients take advantage of the coloscopy prevention program that has been offered sinceOctober 2002. Many people avoid the presumedstressing and uncomfortable examination. As an alternative they can take advantage of the offeredivd blood stool examination. Until now, the only co-vered screening test is a so-called rapid diagnostictest strips. The significantly improved immunologi-cal test kit for occult blood using a one-enzyme system indicating metabolism products of a coloncancer, are not yet covered by the compulsory health insurance. Contrary to the current stool ex-aminations, no special dietary instructions have tobe followed with these modern tests and a signifi-cant more precise diagnosis is feasible.

Market in Motion

For several years now, there has been a strong consolidation of services for care providers, i.e., laboratories. Many hospital laboratories are beingclosed down and outsourcing is taking place.Other hospitals are building networks or are beingtaken over by private institutions. In the area of am-bulant medical care the trend towards consolida-tion is even stronger. Only a few laboratory chainswill survive in the medium term in Germany – experts expect less than 20 companies to survive.There is also a strong trend to internationalizationof laboratory services. The ever-growing laboratoryunits demand optimized workflows with processcost as low as possible. All ivd providers have toadjust their portfolio accordingly. The marketneeds fully automated solutions that optimize theworkflow and require little manual input. The opti-mization of the whole process under the stand-points of quality, time and cost are central tosuccess. Chances for corporations that provide automated laboratory lines and platform techno -logies are opening up. In addition to performinganalysis in laboratories, the demand for productsfor the so-called emergency or 24-hour diagnos-tics laboratory is increasing. For this purpose 'Point of Care' products are used to enable easyhandling and reliable quality control.

12 in vitro diagnostics – A future-oriented market in movement

Industry in Flux

The ivd industry is also changing. In addition tomany small primarily research-oriented corpora-tions, three trends are emerging:

• The great synergic potential between pharmaceu-ticals and diagnostics is leading towards corpora-tions that cover both areas. Diagnostics play a bigrole in research of new substances. The ‘persona-lized therapy’ (matching of a treatment to the individual through appropriate ivd) will becomeaccepted in the medium or long term.

• ‘In vitro laboratory diagnostics’ and ‘in vivo medi-cal techniques’ (imaging diagnostics) branches ofcorporations are being merged. The aim is to optimize workflow with regards to the completehealthcare process (patients, diagnoses, thera-pies) and the development of new biomarkersand their combination with imaging techniques.

Dr Jürgen Schulze

President of The German Diagnostics

Industry Association (VDGH)

Mainzer Landstraße 55

60329 Frankfurt am Main | Germany

Managing Director of

SYSMEX DEUTSCHLAND and

SYSMEX EUROPE GMBH

Bornbarch 1

22848 Norderstedt | Germany

T: +49 40 534 102-280

[email protected]

• Last, but not least, there are ‘pedigreed’ diagnos-tic corporations who operate very successfully.The product complexity in the area of diagnosticsalone is already very demanding since providershave to be proficient not only in equipment tech-nology, reagent development, production, etc.,but also in areas such as software, application, automation, and workflow. The advantage of suchcorporations is that they can concentrate their resources on ‘their market’ – the laboratory.

The trend to consolidation seen for laboratories willpossibly extend to other corporation and networkstructures. All market participants envision the greatpotential for the field of ivd, and are ready to usetheir possibilities to exploit these potentials.

In Germany, in vitro diagnostics (ivds) were for along time statutorily regulated like medicinal pro-ducts. Today, they fall under the Act on MedicalDevices. Manufacturers are thus allowed to bringnew low risk category ivds or batches of such pro-ducts onto the European market without govern-mental control or approval. However, statutorydemands are stricter for ivds in higher categories.Private certification and testing institutes offer theirexpertise to manufacturers. An ivd testing labora-tory at the Paul Ehrlich Institute (PEI) in Langen,near Frankfurt, may be subcontracted for some activities in this field.

In line with the new European regulations thathave been in place since the beginning of thenew millennium, ivds no longer have to be governmentally approved, but only require a CEmarking. By labeling a product with a CE mark,the manufacturer certifies that a product was ma-nufactured in accordance with the existing Ger-man and European Union product safety regula-tions. The CE label does not automatically implythat the device was checked by an independentbody to assure that these regulations were met.

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The new regulations are based on the Europeanivd Directive (Directive 98/79/EC). This has been in effect since 1998, replacing the quite differingnational regulations in various European memberstates with a unified European policy. In Germany,it was implemented into national law in 2002through a second amendment to the Act on Medi-cal Devices.

Thus, in Germany, the former governmental controlof ivds has been transferred to the responsibility ofthe manufacturer. The European regulations dif-ferentiate risk classes of ivds that have to meet dif-ferent requirements. However, the majority of theivds are under the sole responsibility of the manu-facturer, and hence are only tested and assessedby him. Thus, the manufacturer can independentlylabel the products with a CE mark, fulfilling the requirements for placing the product on the Euro-pean market.

High Risk Level Demands External Assessment

ivds of the highest risk category place higher de-mands on the manufacturers. These ivds includetests that detect dangerous viruses that may betransmitted by blood donations. Among those areprimarily the AIDS virus HIV and the two hepatitisviruses B and C (HBV and HCV). ivds used to deter-mine the most important blood groups (AB0 sys-tem, rhesus, Kell) also belong to the highest riskcategory of the ivd Directive, as well as detectionsystems for HTLV virus I and II and HDV.

Regulatory View of in vitro diagnosticsMicha Nübling, Paul-Ehrlich-Institut

Many of these ivds are manufactured using biolo-gical or biotechnological processes that are oftennot as easily standardized as chemical processes.Because of these biological production methods,some including use of cell cultures or bacteria, anextremely consistent, accurate and controlled pro-duction over many batches is necessary for a time -ly detection and prevention of any large variationsin quality.

The manufacturer has to have his internal qualitycontrol systems for all high-risk tests audited be-fore placing the ivd on the market. This involves,for example, performing legally required studiesfor the ivd according to a particular plan. Also eachproduction batch of these tests has to undergospecific controls. The producer commissions a pri-vate authority as “notified body” for both the eva-luation of the studies and the batch testing. Thenotified bodies are neutral, independent and com-petent bodies that perform auditing or what isknown as conformity assessments of products pur-suant to the ivd Directive and ISO/IEG17000:2004.The participation of a notified body can be seen by the specific number below the CE mark, whichidentifies each notified body.

The PEI Reviews and Checks Important ivds

The PEI, because of its long-standing experience intesting ivds, is in great demand as a partner by ma-nufacturers and notified bodies. For several deca-des, when ivds still fell under the German DrugLaw, the PEI was the central institute for evaluatingthe quality of tests for pathogenic agents, e.g.,AIDS tests and diagnostics for hepatitis viruses.This forms the basis of PEI's expertise in the eva-luation and batch release testing of ivds.

In its new role as a testing laboratory, the instituteoffers to conduct studies to assess the quality ofnew ivds or to test new production batches beforethey arrive on the European market. The certifica-tes of the PEI are acknowledged worldwide. Manycountries in Asia or South America demand a certi-ficate from the PEI before the ivds are allowed intotheir country.

Expertise is Growing with the Market

Over the past decade, new technological procedu-res have found their way into diagnostics. Develop-ments towards more sophisticated antibody tests[immunoassays, such as enzyme-linked immune assays (ELISAs)] as well as the introduction of newtechnologies have taken place. Here too, the PEIwith its examinations is always at the cutting edgescientifically and technologically.

The latest most important technologies includemolecular tests for detecting tiny amounts of virusin blood that are only measurable by artificially

14 Regulatory view of in vitro diagnostics

Paul Ehrlich was the first director of the Paul Ehrlich

Institute and a Nobel Prize laureate in medicine in 1908.

(Source: PEI)

nal products. These include, for example, vacci-nes and blood products as well as substancessuch as monoclonal antibodies or artificial nucleic acids for gene therapy. Unlike in PaulEhrlich’s time, the authorization and control ofmedicines are increasingly performed at a Euro-pean level today.

The Paul Ehrlich Institute reports to the FederalMinistry of Health and employs over 700 staff.They primarily deal with questions on the safetyand efficacy of biological medicinal products,are involved in approval and marketing authori-zation activities for these products and conductinternationally renowned experimental researchin the field of life sciences.

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The buildings of the Paul Ehrlich Institute in Langen near

Frankfurt am Main form a Y-like structure (when seen

from above) – characteristic for antibodies. (Source: PEI)

multiplying the viral nucleic acid in vitro to a detec-table concentration. One method for this is the polymerase chain reaction (PCR), an essential fortoday's modern research laboratories. The ivd industry now offers automated PCR systems thatrelieve laboratories and blood banks from many ofthe steps that were previously labor intensive andprone to error. At the PEI even the reagents devel-oped for these modern analytical methods arecontinuously subject to quality control before newproduction batches are released on the Europeanmarket. At this point we come back again to manybiological medicinal products that are also hand-led at the PEI for regulatory purposes or in re-search projects. Biological materials from whichthese medicinal products are prepared (e.g.,human blood plasma) are often tested for virusesand other pathogenic agents using these efficientmolecular detection methods to guarantee effec-tive and safe medicinal products.

History of the Paul Ehrlich Institute

The PEI, originally established in 1896 as an institu-tion for serum research and serum testing in Steg-litz, Berlin, is today still active in the industrial areaof Langen south of Frankfurt. It was named after itsfirst director – the physician and later Nobel Prizelaureate Paul Ehrlich. He had the assignment to develop and implement the basic principles of governmental control of medicinal products.

Today the tasks of the PEI still concentrate on te-sting and research in the area of biological medici-

Dr. Micha Nübling

Paul-Ehrlich-Institut

Molecular Virology

Paul-Ehrlich-Str. 51-59

63225 Langen | Germany

T: +49 6103 77 3304

[email protected]

Basis for Optimal Patient Care: Laboratory Diagnostics in Clinical PractiseHarald Renz, Philipps-University, Marburg

During the last decade laboratory medicine has developed into a medical discipline that is indis-pensable for daily clinical routine. About 80% of allmedical diagnoses are made through or confirmedby laboratory examinations. Laboratory medicine isan extremely inexpensive facility, constituting only1.5% of the hospital budget. Besides the wide-ranging skills of the laboratory medi cine specialists,acquired during 5 years of extended vocationaltraining, the field is also distinguished by a broadmethodological competence. Recently, this aspecthas gained in impor tance through the introductionof a multitude of complex and innovative methods,for example automated immunoassays, nephelo-metry, turbidimetry, mass spectroscopy, atom absorption and flame photometry, which have developed to maturity out of basic biomedical research.

In day-to-day laboratory operation, quality manage-ment is essential. And this high quality of medicaldiagnostics has to be ensured 24 h a day, 365 daysa year. Laboratory medicine was one of the first medical disciplines that established comprehensivequality management in form of ‘round robin profi-ciency test’ that is embedded in law and thereforebinding for all users of laboratory diagnostics.

The latest developments in quality manage mentconcern accrediting medical laboratories accord-ing to ISO/DIN norms. In Germany, the MarburgUniversity Institute was the second University insti-tution that has reached this highest standard ofquality assurance. From this it is clear that labora-tory medicine possesses a particular competencefor optimising complex process procedures. Thetime between arrival of the sample in the labora-tory and the delivery of diagnostic findings to thesender, the so-called turnaround time, has to bekept as short as possible. In this short time, high complex analytics, quality assurance and medicaldiagnosis have to take place.

Trend towards Automation and Specialisation

With the latest developments, the field is movingbetween the two antipodes of an increasing auto-mation on the one hand and specialisation on theother. Today about 2,000 different laboratory testsare routinely available worldwide, of which 600 areoffered in the central laboratory at the UniversityHospital Gießen (Gießen, Germany) and MarburgGmbH (Marburg, Germany). Of these, 120 are so-called vital parameters requiring a basic laboratoryturnaround time of about 30 min. This area makesup nearly 70% of the analyses of the central labor-atory. So, the last 30% of analyses require one of~480 laboratory tests, which are performed in different areas of specialty within the MarburgInstitute.

16 Basis for optimal patient care: Laboratory diagnostics in clinical practise

This again will directly effect the definition of laboratory medicine since the entire chain of riskassessment, prevention, diagnoses of diseases,monitoring of treated patients and assessment ofthe prognosis significantly relies on laboratorytests. The latest developments bring laboratorymedicine very close to the diagnostic industry thatcan only develop, verify and market new tests incooperation with the users of medical diagnostics.With its high standard of laboratory performanceas well as its expertise in basic research, the De-partment of Clinical Chemistry and Molecular Dia-gnostics at the University Hospital Gießen andMarburg can significantly contribute to the devel-opment of innovative diagnostic tests and associa-ted technologies.

Harald Renz, MD

Chairman and ProfessorHead of the DepartmentClinical Chemistry and Molecular Diagnostics- Central Laboratory - Hospital of the UniversityBaldingerstr.35033 Marburg | Germany

T: +49 6421 [email protected]

17

Among the most important are allergy diagnostics,diagnostics of autoimmune diseases, hormonal imbalances, measuring of metabolic performance,analysis of functions in body defence, diagnosticsof infectious diseases, coagulation disorder, toxico-logy, analysis of vitamins and trace elements.

Individualized Allergy Therapy

With increasing cost pressure, setting up labora-tory networks and laboratory co-operations is ex-tremely important to maintain high medical andtechnical performance. With its special medicalcompetence in the research on inflammation, theMarburg institute is optimally integrated into thesenetwork structures. Today, this is the only way toguarantee efficiency in this tremendously fast de-veloping field.

In the Marburg institute, several internationally ac-credited research groups are working in the areaof chronic inflammations that in the last decadehave become widespread diseases. Among theseare asthma, atopic dermatitis, food allergies, rheu-matism and other autoimmune diseases. Thesecomplex diseases develop through interactionsbetween genes and the environment that are notyet fully understood. Since standard therapies arenot applicable for every patient, these diseases de-mand a complex and individualised therapy. In thecoming years this will lead to an increasing devel-opment of subtyping – subcategories of a disease –that will provide the basis for a specialised andpersonalised therapy.

Predicting the Response to the High-Value Medicines of TomorrowThomas Henkel, targos molecular pathology gmbh

Based on the current assumptions, the majority ofdrug treatments are ineffective because the deci-sion for a drug prescription is mainly driven by sta-tistical results for a patient population rather than adiagnostic result for an individual patient. In manycases the decision is not evidence based at all. Thissituation is becoming increasingly unacceptable,and hence addressing the challenge of predictingthe response to a specific drug treatment is an im-perative for three main reasons: First, selecting pa-tients likely to benefit most from a drug from thosewho predictably will have no benefit is highly ethi-cal. Second, healthcare professionals and health-care providers worldwide need diagnosticguidance on how to handle the mismatch betweeninnovative high-value medicines and limited finan-cial resources. Third, it is of economic advantagefor the pharmaceutical industry to stratify patientpopulations in clinical drug development and strati-fication thus helps to increase medical innovation.

For these reasons, in March 2005, the U.S. Foodand Drug Administration (FDA) issued a guidancethat requests the submission of all available valida-ted biomarker data for any application for a newdrug. The European Medicines Agency (EMEA) has its own regulations, which are sometimes evenstricter than those of the FDA, as seen with the re-cent approval of the anti-cancer drug panitumab(Amgen Inc.), for which a diagnostic test ruling outtherapy resistance is required in Europe but not inthe US.

Predictive Biomarkers Optimize Prescription

The instruments to address these challenges are validated predictive biomarkers. Unfortunately onlyfew of these biomarkers have made their way to clinical practice, e.g., Her2 testing by immunohisto-chemistry or by in situ hybridization for the selectionof breast cancer patients eligible for trastu zumab(Herceptin, Roche) treatment; HLA B*5701 genoty-ping for the identification of HIV-infected patientsmost at risk for abacavir-related hypersensitivity re-actions (Ziagen, GSK); the immunohistochemistrytesting for the presence of estrogen receptors andprogesterone receptors as prerequisite for anti-hormonal therapy in breast cancer patients; or theabove-mentioned analysis of K-ras mutations by RT-PCR to identify therapy resistance to panitumabin colon cancer patients.

To improve this situation, many drug developmentcompanies have dramatically increased their effortsto co-develop predictive biomarkers together withnew targeted therapies. Some pharmaceutical com-panies have joined forces with diagnostic compa-nies, such as Eli Lilly Co. and GE Healthcare; in somecases the pharmaceutical and diagnostic branchesof one company have started joint activities (e.g.,Roche Pharma and Roche Diagnostics) with a clearfocus on predictive pathology.

The pharmaceutical industry’s fear of fragmentedmarkets due to patient stratification is diminishing,with more success stories such as Gleevec (Novartis)for small selected patient collectives.

Finally, healthcare providers in California, USA andQuebec, Canada have started to analyze life-cycle

18 Predicting the response to the high-value medicines of tomorrow

targos collaborates with the Institute of Pathology atthe University Hospital in Bonn to extend its exper-tise and capacities in pathology.

Due to its strategic position, targos can act as abridge between the pharmaceutical and diagnosticindustries developing the new high-value drug treat-ments and diagnostic tests, and the diagnostic insti-tutions that have the task to provide patients withnovel predictive tests under the increasing financialconstraints of the healthcare systems.

In the next decade we will see an increasing impor-tance of predictive biomarkers. Once more testshave been validated and approved, and more healthcare providers have calculated the benefit ofpatient stratification to the healthcare budget, pre-dictive biomarker testing will not be primarily offeredto patients within clinical trials but will be part ofdaily clinical routine. targos has taken up the chal-lenge of the internationally growing demand andaims to thrive and to remain a high-quality partnerfor the pharmaceutical and diagnostic industries aswell as for the diagnostic institutions.

Dr Thomas Henkel

Chief Executive Officer

targos molecular pathology gmbh

Mönchebergstrasse 41-43

34125 Kassel | Germany

T: +49 561 980-4100

[email protected]

19

costs for a given disease. This will allow calculatingthe impact of improved therapy prediction usingnovel diagnostic tests on the overall costs of diseasetreatment. In general, the costs for selecting suitablepatients for a targeted drug treatment are less than10% of the costs for the drug itself.

Validation in Close Collaboration with Clinical Pathology

Predictive biomarker testing in oncology is mostlyperformed using molecular pathology – a tight inter-disciplinary cooperation between molecular biologyproviding the test platforms and clinical pathologyproviding the knowledge about tumor cells, tissueand disease. targos molecular pathology gmbh wasfounded to meet the increasing international de-mand by applying highly standardized biomarkeranalysis.

The company’s core business is to discover, applyand validate highly standardized predictive biomar-kers in human medicine. Founded in 2005 in Kassel,targos’s (currently 38) employees offer a clinical andscientific biomarker service to the international phar-maceutical and diagnostic industries under strictquality and project management. More than 40,000patient tissue samples from over 60 countries havebeen analyzed in the targos labs since its inception.

targos collaborates closely with the large, experi-enced pathologist team of the Pathology Nordhes-sen, a private pathology institute in Kassel, with itsfocus on tumor pathology and predictive pathology,an expertise that the institute also provides to thehospitals and physicians in the region. In addition,

In modern medicine, diagnosis and therapeuticmonitoring relies extensively on in vitro diagnostic(ivd) systems. Such systems are capable of deter-mining a variety of different parameters, mostlyfrom blood but also from urine, liquor or saliva. Abroad range of different diagnostic assays are avail-able ranging from mass tests like glucose, variouspanels such as infectious diseases to very specificDNA based determinations. Such ivd systems arenow used in hospitals, blood banks and forensicscience, as well as research laboratories or centra-lized laboratories, which sometimes process manythousand samples a day. The increasing economicpressure drives the need for highly reliable, high-throughput automated ivd analysers, which repre-sent the most cost-efficient processes.

BIT Analytical Instruments, a member of the Messergroup, has been involved in the design and manu-facturing of medical analytical instruments for morethan 30 years. Recently BIT has expanded its marketposition in the US by introducing Source Scientific,based in Irvine, CA, as a new member of the nowglobal BIT Group.

BIT Group offers its customers a comprehensiveOne Stop Solution service with respect to develop-ment, manufacturing and after-sale services for ivd analysers and biochemical or pharmaceuticalinstruments. Such instrumentation is marketed byBIT's customers together with their own reagents,disposables and reagent–related software and soldunder their brand. Consequently, in such cases, IP'sfor ivd systems are retained by BIT`s customers andthe cooperation functions within long-term partner-ships.

Meeting Customer Requirements

Both parties bring their know-how into the partner-ship – BIT from the technical and the customer fromthe application side – to develop tailor-made solu-tions. At the beginning of a cooperation, require-ments regarding services around medical automa -tion as well as instrumentation are clarified. Suchservices may comprise:

• feasibility studies

• comprehensive “turn-key” instrument- or module-developments

• provision of prototype batches for system evalua-tion or field trials

• transfer of developments into manufacturing

• system integration of instrument, software, reagents and disposables

• shipping and logistics services

• after-sale services.

Experience and use of FDA- and ISO-compliant processes is essential. BIT is FDA registered and certified according to ISO 13485 and 9001.

The customers' main requirements are besides BIT`stechnical capabilities a short “time to market” as wellas very competitive development and manufactur-ing costs. To achieve this, an appropriate platformstrategy is employed.

20 Efficiency through integration: Development of diagnostic platforms

Efficiency through Integration: Development of Diagnostic Platforms Alfred Lang, BIT Analytical Instruments GmbH

Challenges and Solutions

Obviously some modules are common and oftenused either in different types of analysers (such asrotor drives, robotic units, temperature controls,etc.) or within one type of analyser (such as detec-tion units or user software modules).

Thus, a set of platform modules providing standardand off-the-shelf solutions is available. However, typically, there are different requirements even within one type of analyser. For example, rotorsizes vary due to different assay packaging dimen-

21

Such platforms are applicable to ivd analysers for:

• clinical chemistry, employing enzymatic and ho-mogeneous immunoassays as well as electrolytes.

• coagulation

• immunology, using antibodies or antigens boundon solid phases such as tubes or (magnetic)beads.

• DNA, generally using chip-based technologies inconjunction with temperature cycling.

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sions (different bottles, reagent packs) or variablethroughput or “walk away time” requirements. The-refore, just employing a single module for differentcustomer projects will not usually be an option. Ty-pically a high level of modularisation usually leadsto some over-engineering, with features being in-cluded to maintain modularity that are not alwaysrequired. Such unnecessarily increased modulecosts may be caused.

The BIT Group has therefore gone “one step back”and has developed autonomous sub modules(ASM) that are independent of such varying requi-rements. Examples of such ASM are:

• linear drive • z,α drive • rotor drive• diluter• needle + liquid

level detection

System Development in Cooperationwith Customers

The BIT Group provides the system and engineeringskills necessary for such analysers. This includes de-velopment of the mechanical, optical, and liquid flowprocesses as well as the electronics and software.Specific focus is given to manufacturability within robust and reliable procedures.

Projects are run by a System Project Manager who isthe contact person for the customer. An integratedproduct development team is established, compris-ing a core team with the appropriate instrument

22 Efficiency through integration: Development of diagnostic platforms

• wash unit• agitation unit• photometer unit• microcomputer unit• microcomputer

basic control shell

Alfred Lang

CTO

BIT Analytical Instruments GmbH

Am Kronberger Hang 3

65824 Schwalbach am Taunus | Germany

T: +49 6196 806 101

[email protected]

engineering skills and an outer team integrating custo-mers activities (assay development, cartridges, reagentpackaging, barcodes, user–software, system integra-tion, etc.). Once in manufacture, a product life cyclesupport is provided.

Rhine-Main Area – an Ideal Location

For BIT, access to universities and institutes as well as to engineering and rapid prototyping partners inclose vicinity is vital. Local universities also provide pro-fessionally educated staff with a broad range of skills.Generally, the innovative and high-tech environmentwithin the area is of notable benefit for BIT's business.In addition, there are several customers in close vicinityto BIT Analytical Instruments in Schwalbach. With BITGroup having local as well as international customersand with its daughter company in California, quick access to the local air, rail and motorway services is es-sential. The public transport and motorway complexesavailable represent a very considerable advantage ofthe Hessen Rhine-Main area.

Abbott Diagnostics has created a network ofstrategic multi-year and multi-project allianceswith leading academic institutions in the USA,Europe and Japan, called Centers of Excellence(COE), that supports internal R&D teams duringthe Research phase in ensuring technical andcommercial success of product development ef-forts. Three of Abbott´s nine COE´s are locatedin Germany and focus on markers for cancer,cardiovascular and infectious diseases. Theysupport the identification and assessment ofnew leads as well as the definition of user needsand product requirements to ensure develop-ment of differentiated, best-in-class products.

Moreover, they evaluate performance characte-ristics of prototypes and provide early, “realworld” feedback to help determine whether adesign concept is ready to move forward intoDevelopment and Design Control. As a result,development cycle times and launch dates havebecome more predictable.

In support of the development phase activities,Abbott Diagnostics has established co-develop-ment joint ventures with established ivd compa-nies worldwide. Abbott forms partnerships withthese original equipment manufacturing (OEM)companies to expand development and manu-facturing capacity and to access certain novelbiomarkers. Co-development partnerships haveproven to be a key concept to accelerate the expansion of the product portfolio and to helpexecuting commercial and regulatory strategiesfor new products.

23

External Innovation Management is becoming acore expertise in building a differentiated pro-duct portfolio, and companies rely increasinglyon collaborations with external partners, fromnew lead identification to market introduction ofnew products. At Abbott Diagnostics Division, aleader in in-vitro Diagnostics, the New ProductDevelopment process is separated into two pha-ses: the Research phase with discovery, conceptdefinition and feasibility activities, and the Devel-opment phase with formal Design Transfer, Veri-fication and Validation and market launch.Abbott has established two strategic and com-prehensive concepts for external R&D partner-ships that are aligned with these two phases.

Bringing New Ideas into Life with a Big PartnerMichael Hausmann, Abbott Diagnostics

How to Start a Partnership

Development & Manufacturing partnerships needto be carefully selected and managed. Selection criteria - apart from financial terms – typically include technology capabilities and pro-duct offering of the potential partner, size and re-source complementarity, and its track record ofcollaborations with other firms. Also, cultural fit, acommon understanding of quality system require-ments and the level of general project execution,manufacturing and supply chain capabilities turnout to be key success factors in maintaining an effective relationship.

Even more than with internal development efforts,an early and joint definition of timeline expecta-tions and deliverables for the different project milestones, product requirements, roles and re-sponsibilities and decision making processes, intel-lectual property management, and communicationplans is essential.

At Abbott Diagnostics, contracts, project plans aswell as quality agreements outline expectationsand responsibilities between Abbott and its OEMpartners. Roles and responsibilities differ from pro-ject to project and depend on the individual capa-bilities and the capacity of the partner. In manycases, new product concepts are defined by the in-ternal (Abbott) R&D department and the prototypeis transferred to the partner for development andmanufacturing. Abbott provides technical and operational know-how, labeling and translations,

as well as Marketing, Clinical Research, Quality Assurance, Regulatory Affairs, and Supply Chainmanagement support. Abbott will market and distribute the new product worldwide.

Formal and informal communication prevents rela-tionship issues, which are a common cause for alli-ance failures. Both partners should assign ProjectManagers as key contacts and interface betweenthe companies, who coordinate project activities,establish and monitor timelines and arrange for regular conference calls and face-to-face teammeetings. In addition, Abbott Diagnostics usuallyestablishes Steering Committees that include R&Dand other management from both firms that helpresolving issues and facilitate decision making, andprovides dedicated Relationship Managers, whohandle business and contractual aspects of thepartnership and ensure that financial issues do not interfere with the daily interaction of the R&Dproject teams.

Benefits for Both Sides

External innovation is an opportunity for all partiesinvolved, an opportunity for the smaller partner tocommercialize new products, to learn from the lar-ger partner in terms of new product development,quality, regulatory and manufacturing processesand systems, and an opportunity for the largerpartner to expand development capacity and toprovide differentiated new products.

24 Bringing new ideas into life with a big partner

25

However, R&D partnerships require enduring com-mitment from all partners and relationships needto be carefully managed. Maintaining trust in thepartnership and resolving issues quickly and mutually are the basis for an effective long-termcooperation.

Abbott is a Big Partner

Abbott Laboratories is a broad-based health carecompany that discovers, develops, manufacturesand markets products and services that span thecontinuum of care – from prevention and diagnosisto treatment and cure. Abbott's principal busines-ses are global pharmaceuticals, nutritional and medical products, including diagnostics and car-diovascular devices. Headquartered in north sub-urban Chicago, Abbott serves customers in morethan 130 countries, with an employee base ofmore than 68,000 at more than 100 manufacturing,distribution, research and development, and otherlocations around the world.

The headquarter of Abbott's Diagnostics Divisionfor Europe, the Middle-East, Africa and India hasbeen established in Wiesbaden-Delkenheim in theearly 80s and employs more than 500 people inmanufacturing, quality assurance, supply chain andR&D. The site manufactures reagent kits and com-ponents equivalent to 3 Million tests per day forthe fully automated PRISM, AxSYM and ARCHI-TECT analyzers, with a focus on Immunoassays forthe prevention, diagnosis and monitoring of infec-tious diseases.

Michael Hausmann, PhD

Director R&D

Abbott Diagnostics Division

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden | Germany

T: +49 6122 581764

Overview

Abbott GmbH & Co.KG

ANALYTICON BIOTECHNOLOGIES AG

BAG Health Care GmbH

Biaffin GmbH & Co KG

Biohit Deutschland GmbH

BIOTEC-FISCHER GmbH


CYTO Labor- und Vertriebs-GmbH

Dade Behring Marburg GmbH A Siemens Company

DiaSorin Deutschland GmbH

Döll + Co. Medizintechnik GmbH

DRG Instruments GmbH

Elté Sensoric GmbH

Genzyme Virotech GmbH

HUMATRIX AG

Immucor Medizinische Diagnostik GmbH

IMMUNDIAGNOSTIK AG

Immunodiagnostic Systems (IDS) GmbH

Immunolab GmbH

INNO-TRAIN Diagnostik GmbH

Keller Medical GmbH

LABCON GmbH

Milenia Biotec GmbH

mti-diagnostics Gesellschaft für medizin. + techn. Investitionsprojekte mbH

NatuTec GmbH

R-Biopharm AG

RCC Cytotest Cell Research GmbH

ScheBo Biotech AG

targos molecular pathology GmbH

Viro-Immun Labor-Diagnostika GmbH

Zedira GmbH

26 Company Profiles

27 Company Profiles

Abbott GmbH & Co. KG

Max-Planck-Ring 265205 Wiesbaden | GermanyT: +49 6122 58 0F: +49 6122 58 1244www.abbottdiagnostik.dewww.abbottdiagnostics.com

ANALYTICON BIOTECHNOLOGIES AG

Am Mühlenberg 1035104 Lichtenfels I GermanyT: +49 6454 79 91 [email protected]

Contact: Andreas Busching

Year of Foundation: 1980Number of Employees: 87

Core Activities:

✓ Laboratory Diagnostics✓ Rapid Diagnostic Tests/POCTs✓ Clinical Chemistry✓ Immunochemistry

Microbiology/BacteriologyHaematology/Histology/CytologyInfectious ImmunologyMolecular Biology

✓ Analytical Instruments/Testing Equipment✓ Software (Operation, Data Management, Automation)

Consumables✓ Manufacturing ✓ Research & Development

ServiceContract Research

✓ Sales and Distribution Trainings and Education

Company Profile:

Analyticon® Biotechnologies AG, with currently 87 em-ployees, manufactures diagnostic tests for human medi-cine at two locations in north Hessen. The companydistributes its products via a worldwide network ofdealers and branch offices in currently 89 countries. Inthe first quarter 2008 a subsidiary in the US was establis-hed. Analyticon Biotechnologies AG fulfils the require-ments of the German law on medical products and theGuidelines of the German Medical Association, also therequirements of the US Food and Drug Administration(FDA) and the Chinese State Food and Drug Administra-tion (SFDA). All products are manufactured in compli-ance with GMP regulations and DIN EN ISO 13485. The company guarantees complete quality control fromdevelopment through production to distribution.Analyticon® Biotechnologies AG carries out continual research and development to improve and extend its ivd portfolio and to maintain quality at the highest level.The core competencies of Analyticon® are in the field ofquick tests – including point of care tests (POCTs) andself-tests for home use. The proposed biomarkers covera wide range of clinical uses.

Year of Foundation: 1888 (in Chicago / USA)Number of Employees: 4100 (in Germany)

Core Activities:


Microbiology/Bacteriology✓ Haematology/Histology/Cytology✓ Infectious Immunology

Molecular Biology✓ Analytical Instruments/Testing Equipment✓ Software (Operation, Data Management, Automation)

Consumables✓ Manufacturing ✓ Research & Development✓ Service

Contract Research ✓ Sales and Distribution ✓ Trainings and Education

Company Profile:

Abbott is represented in Germany with locations in Wiesba-den, Ludwigshafen, Wetzlar, and Rangendingen. Approxima-tely 1,700 employees work in Wiesbaden and the executiveboard for all commercial activities in the fields of pharmaceuti-cals (AI), lab diagnostics (ADD), blood glucose monitoring(ADC) and nutritionals (ANI) also is located here. Wiesbaden isone of the most important sites worldwide in the field of labdiagnostics. Since headquarters for the entire diagnostics in-dustry in Europe, the Middle East and Africa are here at home,this means that the entire region is serviced by scientific stafffrom the Wiesbaden hub in marketing, support, regulatory af-fairs and quality processes. Furthermore, the second largest lo-cation worldwide for diagnostics production and developmentis situated in Wiesbaden. From here, the European logisticscentre for diagnostics makes deliveries every day to 140 coun-tries worldwide. German sales in the field of blood glucosemonitoring as well as in lab diagnostics are controlled fromWiesbaden. This includes marketing, support and training withregard to products and equipment, as well as scientific sup-port. In the field of nutrition, the medical-scientific division aswell as the marketing and sales division may be found in Wiesbaden, where the German logistic centre also is located.

28 Company Profiles

BAG Health Care GmbH

Amtsgerichtsstr. 1-535423 Lich I GermanyT: +49 6404 92 [email protected]

Contact: Dr. Nicolas Sachsenberg

Biaffin GmbH & Co KG

Heinrich-Plett-Str. 4034132 Kassel I GermanyT: +49 561 80 44 662F: +49 561 80 44 [email protected]

Contact: Dr. Stephan Drewianka


Core Activities:

✓ Laboratory DiagnosticsRapid Diagnostic Tests/POCTsClinical Chemistry

✓ ImmunochemistryMicrobiology/BacteriologyHaematology/Histology/CytologyInfectious ImmunologyMolecular BiologyAnalytical Instruments/Testing EquipmentSoftware (Operation, Data Management, Automation) ConsumablesManufacturing

✓ Research & Development✓ Service✓ Contract Research ✓ Sales and Distribution

Trainings and Education

Company Profile:

Biaffin specialises in biomolecular interaction analysis(BIA) with modern SPR biosensors and in applications ofBIA technology for customers from the pharmaceutical,biotechnological and diagnostics industries. Biaffin hasacquired long experience and expert knowledge in theapplication of biosensors based on surface plasmon resonance (SPR) and is known as a reliable partner forthe performance of biomolecular interaction analysesand functional assays. The range of services offered alsoincludes the performance of phosphorylation assays andthe development of medium to high throughput functio-nal in vitro assays. Biaffin's products are bioluminescentassays, recombinant proteins (protein kinases), inhibitorsof protein kinases as well as a novel fusion tag techno-logy for combining rapid purification of recombinantproteins with capturing on surfaces for subsequent interaction assays.


Core Activities:

✓ Laboratory Diagnostics✓ Rapid Diagnostic Tests/POCTs

Clinical ChemistryImmunochemistry

✓ Microbiology/Bacteriology✓ Haematology/Histology/Cytology✓ Infectious Immunology✓ Molecular Biology

Analytical Instruments/Testing EquipmentSoftware (Operation, Data Management, Automation) Consumables

✓ Manufacturing ✓ Research & Development


✓ Sales and Distribution ✓ Trainings and Education

Company Profile:

BAG Health Care GmbH is a medium-sized company loca-ted at the outskirts of the Rhine-Main area, engaged in thedevelopment, production and distribution of in vitro dia-gnostics and sterilisation indicators. A further company emphasis is on contract manufacturing of pharmaceuticalproducts. BAG GmbH is committed to fair and offensivecompetition. The qualification, enthusiasm and perfor-mance of its staff are decisive factors for the success ofBAG. The importance of these factors is reflected in thecompany’s obligations towards its customers and em-ployees. The company develops, produces and distributeshuman diagnostics and indicators for the monitoring of sterilisation processes. It also offers contract production ofsolutions for aseptic filling and, more particularly, for freezedrying.

29 Company Profiles

Biohit Deutschland GmbH

Raiffeisenstr. 161191 Rosbach I GermanyT: +49 6003 82 82 [email protected]

Contact: Dipl.-Ing. Uwe Thönges

Year of Foundation: 1988 Number of Employees: 10

Core Activities:

✓ Laboratory Diagnostics✓ Rapid Diagnostic Tests/POCTs✓ Clinical Chemistry

ImmunochemistryMicrobiology/BacteriologyHaematology/Histology/CytologyInfectious Immunology

✓ Molecular Biology✓ Analytical Instruments/Testing Equipment

Software (Operation, Data Management, Automation) ConsumablesManufacturing

✓ Research & DevelopmentServiceContract Research


Company Profile:

Since its foundation in 1988, Biohit has established itself onthe global market with innovative high-tech products for liquid handling. During the last ten years the company hasinvested in the launching of countless new products, newproduction technologies, automation and quality control.During this process, an extensive international sales andmarketing network came into being. Our research and development profited from cooperation with leading researchers at universities and research institutes. In theearly nineties, Biohit started out on the development of newdiagnostic tests and laboratory appliances for further busi-ness areas. Today the company supplies three different topquality product groups – liquid handling products, dia-gnostic tests and laboratory appliances.Biohit has been certified in accordance with the followinginternational standards: ISO 9001: 2000, Quality SystemStandard, ISO 13485: 2003, Quality Systems, ivd / MedicalDevices, ISO 14001: 2004, Environmental Systems, and IS0 17025, Accreditation of Calibration Laboratory.

BIOTEC-FISCHER GmbH

Daimlerstr. 635447 Reiskirchen I GermanyT: +49 6408 60 [email protected]

Contact: Markus Fischer

Year of Foundation: 1974

Core Activities:

✓ Laboratory DiagnosticsRapid Diagnostic Tests/POCTsClinical ChemistryImmunochemistryMicrobiology/Bacteriology

✓ Haematology/Histology/CytologyInfectious ImmunologyMolecular Biology

✓ Analytical Instruments/Testing EquipmentSoftware (Operation, Data Management, Automation)

✓ Consumables✓ Manufacturing ✓ Research & Development



Company Profile:

BIOTEC-FISCHER GmbH manufactures and distributes pro-ducts in the fields of densitometry and electrophoresis, to-gether with the chemicals and disposables needed for theiruse. The company also offers advice and assistance on allproblems in connection with these themes.BIOTEC-FISCHER guarantees its customers maximum carein production and quality control. Customers can be con-fident of receiving only the best high-end products at ext-remely favourable prices. On top of this, BIOTEC-FISCHERguarantees the simplest possible handling of its products in practical use.BIOTEC-FISCHER has been in the market for over 30 yearsand has developed into a specialist in electrophoresis.

30 Company Profiles

CYTO Labor- und Vertriebs-GmbH

Ortsstr. 2235423 Ober-Bessingen (Lich) I GermanyT: +49 6404 90 43 [email protected]

Contact: Inka Petzelt


Core Activities:



✓ Analytical Instruments/Testing Equipment✓ Software (Operation, Data Management, Automation)

Consumables✓ Manufacturing ✓ Research & Development✓ Service


Company Profile:

Since 1982, CYTO Labor- und Vertriebs GmbH has beenproviding in vitro diagnostics for the analysis of immunereactions to foods. The managing directors Dina andHartmut Tulaszewski see their company primarily as aninstitute for clinical nutritional therapy, with nutritionalcounselling as one of the main pillars of its range of ser-vices. From the very outset, the company’s diagnosticshave been aimed at advising and assisting persons whowish to alter their eating habits or are forced by illness toadapt their diet.With its Cytolisa® test, the company was the first on theGerman market to provide a blood test for analysingIgG-mediated immune reactions to food antigens.Since the end of 2005, the company has been certified inaccordance with DIN EN ISO 9001 and DIN EN ISO13485 for “production, development and distribution ofin vitro diagnostics”. The company is based in Lich/Ober-Bessingen in Hessen, 60 km north of Frankfurt.


Am Kronberger Hang 365824 Schwalbach I GermanyT: +49 6196 80 61 [email protected]

Contact: Dipl.-Ing. Alfred Lang


Core Activities:


Microbiology/BacteriologyHaematology/Histology/Cytology

✓ Infectious Immunology✓ Molecular Biology✓ Analytical Instruments/Testing Equipment✓ Software (Operation, Data Management, Automation) ✓ Consumables✓ Manufacturing ✓ Research & Development✓ Service

Contract Research Sales and Distribution Trainings and Education

Company Profile:

BIT Analytical Instruments offers all-round services incontract development and manufacturing, also after-sales service for appliances used by OEMs in the medi-cal, diagnostic and industrial sectors. The company is anindependent market leader in Europe for high-end ivdanalytical instruments in the high-end OEM market.BIT’s core competencies:· Individual contract manufacturing of medium to highlycomplex instrumentations, assemblies and custom-builtproduction facilities.

· One Stop Solution – a partner for your product develop-ment, manufacturing and after-sales service. Alwayswith the highest quality standards according toISO13485 / ISO 9001, FDA-compliant.

31 Company Profiles

Dade Behring Marburg GmbHA Siemens Company

Emil-von-Behring-Str. 7635041 Marburg I GermanyT: +49 6421 39 13F: +49 6421 66064www.siemens.com/diagnostics

DiaSorin Deutschland GmbH

Von-Hevesy-Str. 363128 Dietzenbach I GermanyPhone +49 6074 401 0Fax +49 6074 401 [email protected]

Contact: Dr. Thorsten Hilbich


Core Activities:


✓ ImmunochemistryMicrobiology/BacteriologyHaematology/Histology/Cytology

✓ Infectious ImmunologyMolecular Biology


✓ Consumables✓ Manufacturing ✓ Research & Development✓ Service

Contract Research ✓ Sales and Distribution


Company Profile:

DiaSorin is the embodiment of a tradition of growth andexcellence focused on the improvement of human health. The DiaSorin Group develops, produces, and distributes immunoreagent kits for clinical diagnostics.Thanks to its well-established expertise, specifically in theimmunodiagnostics market, DiaSorin has become “the”in vitro diagnostics specialist. Over the years, by makingavailable to the medical profession tests that can provideoptimum guidance for reaching clinical decisions, DiaSo-rin has contributed to improving the provision of healthcare and reducing its cost. In Germany the Group opera-tes a production facility in Dietzenbach.

Core Activities:

✓ Laboratory Diagnostics✓ Rapid Diagnostic Tests/POCTs✓ Clinical Chemistry✓ Immunochemistry✓ Microbiology/Bacteriology✓ Haematology/Histology/Cytology✓ Infectious Immunology✓ Molecular Biology✓ Analytical Instruments/Testing Equipment✓ Software (Operation, Data Management, Automation) ✓ Consumables✓ Manufacturing ✓ Research & Development✓ Service

Contract Research ✓ Sales and Distribution


Company Profile:

Dade Behring Marburg GmbH with its locations in Marburg,Schwalbach, and Duisburg became part of Siemens Health-care Diagnostics in November 2007. At these locations, theapproximately 1,200 employees of the company producetop-quality diagnostic systems and reagents for clotting, infection and plasma protein testing and ensure prompt delivery to customers. Siemens Healthcare Diagnostics, oneof the leading in-vitro diagnostics in the world, is commit-ted to providing clinicians with the vital information theyneed for the accurate diagnosis, treatment and monitoringof patients. Our comprehensive portfolio of performance-driven systems, unmatched menu offering, and IT solutions,in conjunction with highly responsive service, is designed to streamline workflow, enhance operational efficiency andsupport improved patient care.Siemens Healthcare Diagnostics employs more than 14,000people worldwide and operates in over 110 countries. In the fiscal year 2007 (Sept. 30), Siemens Healthcare Dia-gnostics reported sales of €3.3 billion.The products of Dade Behring Marburg GmbH include abroad range of diagnostic systems for immunoassays, che-mistry, hematology, molecular biology, urinalysis, diabetes,blood gas, clotting, plasma proteins and infection testing aswell as automation, IT and consulting solutions to meet thedemands of laboratories of all sizes.

32 Company Profiles

Döll + Co. Medizintechnik GmbH

Im Langgewann 765719 Hofheim I GermanyT: +49 6192 20 90 30F: +49 6192 20 90 [email protected]

Contact: Christa Schleich

DRG Instruments GmbH

Frauenbergstr. 1835039 Marburg I GermanyT: +49 6421 17 00 [email protected]

Contact: Wilhelm Sänger

Year of Foundation: 1973 Number of Employees: 41

Core Activities:


Clinical Chemistry✓ Immunochemistry

Microbiology/BacteriologyHaematology/Histology/Cytology

✓ Infectious ImmunologyMolecular BiologyAnalytical Instruments/Testing EquipmentSoftware (Operation, Data Management, Automation) Consumables


Service✓ Contract Research ✓ Sales and Distribution


Company Profile:

DRG, founded in 1973, is specialized in the develop-ment, production and global distribution of ELISA andRIA test kits, principally for clinical diagnostics and research. In our production facilities, high-quality andeconomical products are developed in adaptable for-mats – OEM included – which can be fully tailored to individual customer or market requirements. A complete line of laboratory instruments and equip-ment is also provided.Products include ELISAs such as Hepcidin, Estrone,DHEA, Corticosterone, PLGF, the tumour markers CA 72-4, CA 125, CA 19-9, CA 15-3, CYFRA 21-1, Saliva diagnostics and Chemiluminescence assays.


Core Activities:

✓ Laboratory Diagnostics✓ Rapid Diagnostic Tests/POCTs✓ Clinical Chemistry

Immunochemistry✓ Microbiology/Bacteriology✓ Haematology/Histology/Cytology

Infectious ImmunologyMolecular Biology

✓ Analytical Instruments/Testing Equipment✓ Software (Operation, Data Management, Automation) ✓ Consumables

Manufacturing Research & Development

✓ ServiceContract Research


33 Company Profiles

Elté Sensoric GmbH

Wilhelm-Schöffer-Str. 3363571 Gelnhausen I GermanyT: +49 173 94 39 33 [email protected]

Contact: Dr. Andreas Haenel

Genzyme Virotech GmbH

Löwenplatz 565428 Rüsselsheim I GermanyT: +49 6142 69 [email protected]

Contact: Dr. Klaus Ackermann


Core Activities:


Clinical ChemistryImmunochemistry

✓ Microbiology/BacteriologyHaematology/Histology/Cytology

✓ Infectious Immunology✓ Molecular Biology✓ Analytical Instruments/Testing Equipment✓ Software (Operation, Data Management, Automation)

Consumables✓ Manufacturing ✓ Research & Development✓ Service✓ Contract Research ✓ Sales and Distribution ✓ Trainings and Education

Company Profile:

Genzyme Virotech develops, produces and distributes medi-cal diagnostic products. Since the foundation (1986) the pro-duct range has continuously been extended and new pro-duct lines have been added. We interact the co-operationwith universities and research institutes and continuously investin the product development and improvement. Our 100 quali-fied employees are anxious to always provide customers with a high product quality and excellent service. With more than50 distributors we distribute our own products worldwide.For the German market we are exclusive distributors for abroad number of immunological and microbiological detec-tion systems that we purchase from international companies.Our growth strategy is to enter new co-operations, to be able to increase research, development and sales and to fillexisting gaps of our portfolio. Furthermore we are interestedin new technologies and product lines that might be inter-esting for the German respectively the international market.We currently search/offer co-operations in the field of re-search, development, contract manufacturing, distribution ofnew diagnostic and microbiological products and technolo-gies. A corresponding certification in accordance with DIN ENISO 9001: 1994 was already awarded in 1998.


Core Activities:


Clinical ChemistryImmunochemistryMicrobiology/BacteriologyHaematology/Histology/CytologyInfectious ImmunologyMolecular Biology

✓ Analytical Instruments/Testing EquipmentSoftware (Operation, Data Management, Automation) ConsumablesManufacturing

✓ Research & DevelopmentServiceContract Research Sales and Distribution Trainings and Education

34 Company Profiles

HUMATRIX AG

Carl-Benz-Str. 2160386 Frankfurt/Main I GermanyT: +49 69 42 08 86 [email protected]

Contact: Tobias Gerlinger

Immucor Medizinische Diagnostik GmbH

Adam-Opel-Str. 26a63322 Rödermark I GermanyT: +49 6074 84 20 [email protected]

Contact: Heidi Sommer


Core Activities:

✓ Laboratory DiagnosticsRapid Diagnostic Tests/POCTsClinical ChemistryImmunochemistryMicrobiology/Bacteriology



✓ Consumables✓ Manufacturing ✓ Research & Development✓ Service


Company Profile:

Immucor is a global in vitro diagnostics company special-izing in the area of pre-transfusion diagnostics. The com-pany develops, manufactures, and sells products used by hospital blood banks, clinical laboratories, and blooddonor centers to detect and identify certain properties ofhuman blood prior to patient transfusion. Immucor hasrevolutionized the industry through our dedication to au-tomating manual processes in the blood bank laboratory.The German subsidiary – Immucor Medizinische Dia-gnostik GmbH – is located in Rödermark.


Core Activities:

✓ Laboratory DiagnosticsRapid Diagnostic Tests/POCTsClinical ChemistryImmunochemistryMicrobiology/BacteriologyHaematology/Histology/CytologyInfectious Immunology

✓ Molecular BiologyAnalytical Instruments/Testing EquipmentSoftware (Operation, Data Management, Automation) ConsumablesManufacturing Research & Development



Company Profile:

humatrix AG is a biotech company in Frankfurt specializingin analyses of human DNA. Founded in February 2001 byfour young scientists and a young entrepreneur, it is the firstpublic listed company to offer products throughout Ger-many for the analysis and determination of paternity testsand ancestry determinations for both private and judicialpurposes. A high-precision method testing up to 50 iden-tifying characteristics (or “loci”) guarantees as a rule up to99.9999% certainty for the customers of humatrix AG.The product range of humatrix AG also includes a newbornscreening for several health risks (Lactose-Intolerance, Glu-ten-Intolerance, Multidrug-Resistance, Antibiotics-Intole-rance and AAT-deficiency), risk assessments for geneticallyinduced diseases (Parodontitis, Osteoporosis, Hemochro-matosis etc.), identifications of DNA fingerprints, e.g. of suspects or victims, or for bone marrow donor databases,etc.

35 Company Profiles

IMMUNDIAGNOSTIK AG

Stubenwaldallee 8a64625 Bensheim I [email protected]

Contact: Dr. F. P. Armbruster

Immunodiagnostic Systems (IDS) GmbH

Mainzer Landstr. 4960329 Frankfurt/Main I GermanyT: +49 69 30 85 50 [email protected]

Contact: Anke Snethkamp


Core Activities:

✓ Laboratory DiagnosticsRapid Diagnostic Tests/POCTs

✓ Clinical ChemistryImmunochemistryMicrobiology/BacteriologyHaematology/Histology/CytologyInfectious ImmunologyMolecular Biology

✓ Analytical Instruments/Testing EquipmentSoftware (Operation, Data Management, Automation) Consumables




Company Profile:

Immunodiagnostic Systems Limited (IDS) is an innova-tive, dynamic biotech company specializing in the devel-opment and provision of high-end assays for clinical andresearch purposes worldwide. The company is represen-ted in Germany by a branch office in Frankfurt am Main.Increasingly exacting requirements in the laboratorylandscape call for constant improvements in efficiency,quality, costs and clinical differentiation. These factors arethe key to optimum patient care, therapies and diseasemanagement. With these aims in mind, IDS has devel-oped a special robot system with its own panel for thefields of bone metabolism, growth and high blood pres-sure. The panel comprises 25-hydroxy vitamin D, intactand bioactive PTH, BAP, osteocalcin, CTX-I, HGH, IGF-I,IGFBP-3, renin and aldosteron.IDS works together with opinion leaders throughout theworld to optimize the panel with highly specific next-generation disease markers.


Core Activities:


✓ Clinical Chemistry✓ Immunochemistry

Microbiology/BacteriologyHaematology/Histology/CytologyInfectious Immunology

✓ Molecular BiologyAnalytical Instruments/Testing EquipmentSoftware (Operation, Data Management, Automation) Consumables




Company Profile:

Immundiagnostik specialises in developing and producingdetection methods for use in the laboratory and in medicalresearch. Our main customers are involved in routine clini-cal diagnostics in hospitals and private laboratories, as wellas in pharmaceutical companies and in basic clinical re-search. The company maintains an active R & D programme andcontinuously develops new and innovative assays. The pro-duct range has recently been extended by a range of newenzyme immunoassays for stool diagnostics and the pro-duction of our own polyclonal and monoclonal antibodies.We hold a continuously expanding portfolio of products ad-dressing major disease areas as well as highly specialisedniche markets. Our core activities include calcium and bonemetabolism, cardiovascular and renal systems, oxidativestress and gastroenterology. In addition, we provide kits forHPLC applications and molecular biology (PCR).Parameters of special interest: 25-OH-Vitamin D3, OPG,total sRANKL, BSP, ADMA, oxLDL, RBP4, Calprotectin, Norovirus, and Thymus Peptides.

36 Company Profiles

Immunolab GmbH

Otto-Hahn-Str. 1634123 Kassel I GermanyT: +49 561 49 17 42 [email protected]

Contact: Dr. Hans J. Jacobsen

INNO-TRAIN Diagnostik GmbH

Niederhöchstädter Str. 6261476 Kronberg I GermanyT: +49 6173 60 79 30F: +49 6173 60 79 [email protected]

Contact: Dr. Rainer Frank


Core Activities:


✓ ImmunochemistryMicrobiology/Bacteriology

✓ Haematology/Histology/CytologyInfectious Immunology

✓ Molecular Biology✓ Analytical Instruments/Testing Equipment✓ Software (Operation, Data Management, Automation) ✓ Consumables✓ Manufacturing ✓ Research & Development✓ Service


Company Profile:

Inno-Train Diagnostik GmbH is a company set up inFrankfurt am Main in 1998, with its head offices in Kron-berg/Taunus. Its range includes self-produced goods,distribution products and laboratory services.Inno-Train Diagnostik GmbH engages in internationalcompetition with the aim of integrating new, innovativeproducts into the trade with goods in the areas of trans-fusion medicine and immune haematology. Its productrange includes diagnostics and detection systems forspecific analyses at genome level, together with HLA dia-gnostic products. International contacts enable the Inno-Train team to present its products worldwide and at thesame time to establish foreign products on the Germanmarket.As the company name suggests, Inno-Train DiagnostikGmbH is a competent partner in the area of training andconsultancy. It offers long-term assistance on DNA tech-nologies in the form of consultancy contracts, or on-sitetraining courses over periods of several days.


Core Activities:


Clinical Chemistry✓ Immunochemistry✓ Microbiology/Bacteriology

Haematology/Histology/Cytology✓ Infectious Immunology

Molecular Biology✓ Analytical Instruments/Testing Equipment✓ Software (Operation, Data Management, Automation)

Consumables✓ Manufacturing ✓ Research & Development



Company Profile:

Immunolab GmbH was founded in February 1992 in Kasselas routine laboratory closely associated with the immunediagnostics producer MELJA. The company possesses thelegally required authorizations for import and export, hand-ling of radioactive materials in compliance with the Germanlaw on medical products.Immunolab manufactures immunological test kits for appli-cations in the food, environmental and medical sectors. The company operations are concentrated primarily on producing immune diagnostic test kits to determine anti-bodies (IgG, IgA, IgM and IgE) against a number of disease-triggering substances, antigens and allergens.In the food testing field, Immunolab supplies a range ofELISA kits, including histamine, aflatoxins, gliadin, listeriaand chloramphenicol. These parameters are determined in many different matrices (meat, fruit juices, nuts, cereals, vitamin tablets, milk).

37 Company Profiles

Keller Medical GmbH

Wiesbadener Weg 2a65812 Bad Soden I GermanyT: +49 6196 76 46 51 [email protected]

Contact: Isabell Henke

LABCON GmbH

Benzstr. 464646 Heppenheim I GermanyT: +49 6252 94 [email protected]

Contact: Dipl.Ing. Albert Sax


Core Activities:


✓ Clinical Chemistry✓ Immunochemistry

Microbiology/Bacteriology✓ Haematology/Histology/Cytology

Infectious ImmunologyMolecular Biology


✓ ConsumablesManufacturing Research & Development



.


Core Activities:

Laboratory Diagnostics✓ Rapid Diagnostic Tests/POCTs✓ Clinical Chemistry

ImmunochemistryMicrobiology/Bacteriology


✓ Analytical Instruments/Testing Equipment✓ Software (Operation, Data Management, Automation) ✓ Consumables

Manufacturing Research & Development



Company Profile:

Keller Medical is a partner for intelligent point-of-care solu-tions. The company offers solutions for independent mea-surements in all matters concerning blood gases, electro-lytes, coagulation and cardiac markers, using high-perfor-mance, maintenance-free appliances.Keller Medical was started up in 2003 as an exclusive distri-bution partner in Germany for the formerly Linde MedicalSensors AG. The company established itself rapidly as acompetent partner for transcutaneous blood gas measure-ment. Keller Medical was equally quick in adding point-of-care tests (POCT) to its product portfolio and making theman important second mainstay of the company.The company sees itself as a competent partner for its customers, offering them flexible solutions with innovativeproducts and a wide range of services. Keller Medical alsounderstands itself as a competent, partner-like mediatorbetween clinics and manufacturers for the benefit of patients at the POC.

38 Company Profiles

Milenia Biotec GmbH

Versailler Str. 135394 Giessen I GermanyT: +49 641 94 888 3-0F: +49 641 94 888 [email protected]

Contact: Dr. Ralf Dostatni

mti-diagnostics Gesellschaft für medizin.+ techn. Investitionsprojekte mbH

Oberemser Str. 1565510 Idstein I GermanyT: +49 6082 93 05 02 [email protected]

Contact: Robert Dinges


Core Activities:


Microbiology/BacteriologyHaematology/Histology/CytologyInfectious ImmunologyMolecular BiologyAnalytical Instruments/Testing EquipmentSoftware (Operation, Data Management, Automation) Consumables




Company Profile:

mti-diagnostics Gesellschaft für medizin. + techn. Investi-tionsprojekte mbH is a small, highly innovative entrepre-neur network which, in addition to producing standardand system reagents (complete with barcode and readyfor use) in the field of clinical chemistry, also engages inthe development of new reagents, tailored to customerrequirements and made available in the shortest possi-ble time. The resulting test kits are packaged, labelledand designed in accordance with customer wishes.mti-diagnostics is also a specialist for cleaning, rinsing,separating and disinfection solutions for automated analytical systems, pipetting robots and the cell culture facilities in the laboratory.One year ago, reagents for foodstuffs and wine labora-tories were added to the company’s core competence. mti-diagnostics has developed a series of new tests forthis area.


Core Activities:

Laboratory Diagnostics✓ Rapid Diagnostic Tests/POCTs



✓ Analytical Instruments/Testing EquipmentSoftware (Operation, Data Management, Automation) Consumables

✓ Manufacturing ✓ Research & Development✓ Service✓ Contract Research ✓ Sales and Distribution


Company Profile:

Milenia Biotec GmbH develops, produces and markets im-mune diagnostics worldwide. The company was founded in 2000 as a spin-off from DPC Biermann GmbH in BadNauheim.Its core products are point-of-care tests for diagnosing allergies and infections and measuring immune mediators.The company markets its products in Germany through aqualified field staff and abroad via independent distribu-tors.

39 Company Profiles

NatuTec GmbH

Königslacher Str. 15-2160528 Frankfurt/Main I GermanyT: +49 69 67 73 78 [email protected]

Contact: Eva-Brigitte León

R-Biopharm AG

Landwehrstr. 5464297 Darmstadt I GermanyT: +49 6151 81 02 [email protected]

Contact: Ralf Dreher


Core Activities:


✓ Immunochemistry✓ Microbiology/Bacteriology


Molecular BiologyAnalytical Instruments/Testing EquipmentSoftware (Operation, Data Management, Automation) Consumables




Company Profile:

R-Biopharm AG develops pioneering solutions in theareas of clinical diagnostics and food and animal feedanalysis. The company was founded in 1988 as a sub-sidiary of Röhm GmbH in Darmstadt and is certified inaccordance with DIN EN ISO 9001 and quality manage -ment standard ISO 13485.In clinical diagnostics, R-Biopharm possesses many yearsof sound and proven experience not only in the area ofinfectiological stool evaluation but also in serological infection diagnostics and allergies. The company alsosupplies innovative tests for tumour diagnostics and gastroenterology.Since January 2000, R-Biopharm AG has held worldwideexclusive distribution rights for the Enzymatic BioAnalysisof Roche Diagnostics. The acquisition of Rhône Dia- gnostics Technologies in Scotland in 2002 enabled the company to expand its position in the field of food andanimal feed analysis. This field now comprises productswith widely acknowledged immunological, enzymaticand microbiological test kits for the detection of resi-dues, ingredients or microbiological contaminations.


Core Activities:


✓ Immunochemistry✓ Microbiology/Bacteriology✓ Haematology/Histology/Cytology✓ Infectious Immunology✓ Molecular Biology✓

Analytical Instruments/Testing EquipmentSoftware (Operation, Data Management, Automation)

✓ ConsumablesManufacturing Research & DevelopmentServiceContract Research


Company Profile:

NatuTec GmbH is a young German company, founded in1994, with its head office in Frankfurt am Main. The com-pany supplies a wide range of high-end quality reagents for scientists in the fields of immunology and molecular biology, metabolism and cell biology.A constantly expanding product range ensures plenty ofdynamism and promotes the development of completelynew and innovative products at NatuTec.

40 Company Profiles

RCC Cytotest Cell Research GmbH

In den Leppsteinswiesen 1964380 Roßdorf I GermanyT: +49 6154 80 72 [email protected]

Contact: Dr. Völkner

ScheBo Biotech AG

Netanyastr. 335394 Gießen I GermanyT: +49 641 49 96 [email protected]

Contact: Dr. Ursula Scheefers-Borchel


Core Activities:



Microbiology/BacteriologyHaematology/Histology/CytologyInfectious ImmunologyMolecular BiologyAnalytical Instruments/Testing EquipmentSoftware (Operation, Data Management, Automation)

✓ Consumables✓ Manufacturing ✓ Research & Development



Company Profile:

ScheBo®• Biotech AG, founded in 1989, is a biotechcompany specializing in the development, productionand marketing of in vitro diagnostics and the businessareas of active substance research and drug develop-ment.All products possess high innovation potential and weredeveloped with a view to market requirements. The com-pany was founded by the molecular biologists and bio-chemists Dr. Ursula Scheefers-Borchel and Dr. HansScheefers.ScheBo®• Biotech AG operates distributor companies inthe USA (ScheBo®• Biotech AG USA, Inc.) and England(ScheBo®• Biotech UK Ltd). The company is independ-ently managed and keyed to both national and interna-tional markets. All products have unique USPs in the fieldof clinical diagnostics.Consistent orientation to R&D activities, constant optimi-zation of production processes and close focus on mar-ket requirements form the basis for successful launchingand marketing of a wide range of innovative products..


Core Activities:

Laboratory DiagnosticsRapid Diagnostic Tests/POCTsClinical ChemistryImmunochemistryMicrobiology/BacteriologyHaematology/Histology/CytologyInfectious ImmunologyMolecular BiologyAnalytical Instruments/Testing EquipmentSoftware (Operation, Data Management, Automation) ConsumablesManufacturing Research & DevelopmentService

✓ Contract Research Sales and Distribution Trainings and Education

Company Profile:

RCC Cytotest Cell Research GmbH, ever since its founda-tion in 1986, has provided contract research work in theareas of genetic toxicology, cell biology and biocompati -bility testing. The institute, an operational unit for Genetic Toxicology and Cell Biology, belongs to the Research andConsulting Company Ltd (RCC), based in Itingen/ Basel(Switzerland). It originated from the Laboratory for Mutage-nicity Testing (LMP) of the Technical University in Darmstadt,which was set up as the first laboratory of this kind in Germany in 1981. RCC Cytotest Cell Research GmbH has certifications for GLP (since 1986) and GMP (2008).

41 Company Profiles

targos molecular pathology GmbH

Mönchebergstr. 41-4334125 Kassel I GermanyT: +49 561 98 04 10 [email protected]

Contact: Dr. Thomas Henkel

Viro-Immun Labor-Diagnostika GmbH

In der Au 2961440 Oberursel I GermanyT: +49 6171 62 81-00F: +49 6171 62 [email protected]

Contact: Alexander Bücker-Flürenbrock


Core Activities:


✓ Immunochemistry✓ Microbiology/Bacteriology


Molecular BiologyAnalytical Instruments/Testing EquipmentSoftware (Operation, Data Management, Automation) Consumables




Company Profile:

Viro-Immun Labor-Diagnostika GmbH is the diagnosticspecialist for infectious and autoimmune diseases withinBiotest Group and one of the leading international pro-ducers of ELISAs, IFAs and Western Blot kits. We developand produce diagnostics for the serological diagnosis ofviral, bacterial and mycotic infections and autoimmunediseases. Key to our success for over 20 years is the pro-prietary production of antigens, conjugates and othercriticial reagents combined with the utmost adaption ofour kits to specific customer/distributor/OEM specifica-tions.


Core Activities:


✓ ImmunochemistryMicrobiology/Bacteriology

✓ Haematology/Histology/CytologyInfectious Immunology

✓ Molecular BiologyAnalytical Instruments/Testing EquipmentSoftware (Operation, Data Management, Automation) ConsumablesManufacturing

✓ Research & Development✓ Service✓ Contract Research

Sales and Distribution ✓ Trainings and Education

Company Profile:

targos molecular pathology GmbH was founded in 2005 tomeet the increasing need for standardized analyses in thearea of clinical biomarkers. The company cooperates withmany international pharmaceutical and diagnostics com-panies to undertake, for instance, patient selection on thebasis of existing predictive biomarkers in clinical studieswith new, targeted oncological therapies.A further goal of targos is to establish new predictive bio-markers for the identification of suitable patients for specifictherapies. Since this service was introduced, more than40,000 patient samples from 60 countries and 700 clinicalcentres have been tested. One of the largest clinical studiessupervised by targos was the HERA study with more than10,000 patients to investigate herceptin in the adjuvanttreatment of mamma carcinoma. The company is currentlysupervising 30 studies in which a wide variety of targetedtherapies are being investigated in seven different tumourindications.At the present time, the company has a staff of 38 and iscollaborating closely with the private institution PathologieNordhessen in Kassel and the Institute of Pathology of theUniversity of Bonn.


Core Activities::


✓ ImmunochemistryMicrobiology/BacteriologyHaematology/Histology/CytologyInfectious Immunology

✓ Molecular BiologyAnalytical Instruments/Testing EquipmentSoftware (Operation, Data Management, Automation) Consumables




Company Profile:

Zedira has made a commitment to Celiac Disease andTransglutaminase. Our approach to the disorder is multi-faceted. Research & Development: In order to assist investigatorsstudying Celiac Disease and other Transglutaminase relatedphysiological processes and disorders, Zedira offers a uni-que portfolio of specialty reagents for basic research anddevelopment. Diagnosis: About 1% of the population is affected by CeliacDisease. Unfortunately, only about one out of ten of theseindividuals is aware of suffering from the autoimmundisease, which if undiagnosed can lead to serious medicalcomplications. In co-operation with leading Europeanscientists Zedira has succeeded in identifying a new marker(Neuronal Transglutaminase, TG6) for Celiac Disease whichcan be used to detect neurological disorders caused bygluten. Further, Zedira produces standard antigens for Ce-liac Disease diagnostics (TG2, TG3, gliadin peptides etc.)Therapy: At present, Celiac Disease cannot be treated bypharmacological intervention. The only treatment availableto patients is strict adherence to a gluten-free diet. For thatreason Zedira develops a drug to treat Celiac Disease.

42 Company Profiles

Zedira GmbH

Roesslerstr. 8364293 Darmstadt I GermanyT: +49 6151 32 51 10F: +49 6151 32 51 [email protected]

Contact: Dr. Martin Hils

Executing organisation of Hessen-Biotech, a project of the Hessian Ministry of Economics,Transport, Urban and Regional Development


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