Reuma-diagnostiek in beweging

Martin Salden

Euro-Diagnostica

AB

Euro-Diagnostica

ABDBWieslab AB

Wieslab BV Wieslab XX

ED-Group:

Draupnir

ED-Group

NordicGroup

PPLGroup

DraupnirServices B.V.

Draupnir

PolyPeptide Group

• One of the world's leading groups specialized in the industrial scale manufacture of custom and generic peptides for therapeutic (and cosmetic) applications.

• Manufacturing facilities in Denmark, Sweden, France, Czech Republic, USA and India.

Nordic Group

• The Nordic Group is a fully-integrated, pan-European Pharmaceutical Group.

• Nordic Group focuses on two specialized segments of the Pharmaceutical market:- Marketing & Sales of specialty (generic)

pharmaceuticals; - Specialized Pharmaceutical Services focusing on

Product Development, Manufacturing, supplyLogistics and Regulatory activities.

Euro-Diagnostica Group

• Euro-Diagnostica focuses on the diagnosis and monitoring of specific diseases.

• Euro-Diagnostica develops, manufactures and markets complete diagnostic kits and reagents for use in special medical areas like autoimmune diseases and Rheumatology.

• The Group operates from establishments in Nijmegen (The Netherlands) and Malmö (Sweden)

Formation of the company

• 1992: Euro-Diagnostica established by a merger of– Ferring Diagnostica, SE– BioCarb Diagnostics, SE– Euro-Diagnostics, NL– Medscand Diagnostics-MILAB, SE

Strategic Mergers and Acquisitions

• 2004: Acquisition of Wieslab AB – Well established trade name– Added further competence in protein chemistry– Key competence in developing ANCA tests – Scandinavia`s leading private autoimmune laboratory

EuroDiagnostica/Wieslab• Employees

– Malmö, E-DEON Sweden, 70 employees – Nijmegen, Mercator 3 building,The Netherlands, 6 employees

World Wide Distribution Network

• Key Markets– North America– Europe– Japan

– Own distribution of products in the Nordic countries, Benelux, UK and Germany

Cutting Edge Diagnostics

• Euro-Diagnostica is the leader in the development of unique – ANCA tests – Vasculitis diagnosis– Anti-CCP2 based tests – Rheumatoid Arthritis diagnosis

anti-CCP2 ELISA

• The ultimate serological marker for diagnosis of Rheumatoid Arthritis

– Specific – Allows early detection of RA– Sensitive – Prognostic marker

CCPoint® anti-CCP point-of-care test

• The first POC test for anti-CCP– Enables near-patient diagnosis of RA– Enables rapid diagnosis – rapid treatment– Specific and sensitive as ELISA

• Wieslab® SSA p200 ELISA• Wieslab® Complement ELISA

CCP assay based on discovery of Prof van Venrooij

• STW agreement– IP protection. Prepare to defend ?

• Product development– Core technology.– BioBank to validate product.

• Marketing & Sales– ED brand, protect product name CCP!– OEM, no competitive products!– Inventor best promoter of product

• Personal click

Add 5 drops of chase bufferAdd 1 drop of blood

Read the results after 10 min

Open the flip-up after 30 sec

Areas of clinical competence

• Systemic vasculitidies. Rapidly progressing glomerulonehritis.

• Reference laboratory for ANCA testing• Complete range of autoimmune analyses

Service for clients

• Acute testing for ANCA and anti-GBM daily 7/24• Support and interpretation of test results• Analysis packages according to client’s wishes

24 hour service for ANCA and anti-GBM• Rapidly progressing glomerulonephritis• Acute reno-pulmonary syndromes• Qualitative testing of PR3-ANCA, MPO-ANCA and anti-GBM.

High sensitivity.• Results within one hour from the sample reaching the laboratory• Positive results are confirmed by quantitative ELISA the

following day