Bio Oxford

Population Screening Program and Prenatal

Bio-Oxford is a Brazilian company operating in the in vitro diagnostics market for over

10 years as an authorized distributor for Bio-Rad Laboratories, Inc., a multinational

organization headquartered in the US, market and technology leader in various

segments.

Bio-Oxford has over 1,500 clients throughout Brazil and sells 5.8 million tests for in

vitro diagnosis annually.

Bio-Oxford also develops, imports, and commercializes products and equipment for in

vitro diagnosis of infectious diseases for population screening and prenatal and

neonatal screening.

Bio-Oxford

Bio-Oxford has expertise and works in all segments of the in vitro diagnostics market with a focus and leadershipposition in:

POPULATION AND PRENATAL SCREEENINGEquipment, chemical and biological reagents, sample collection kits, logistical and scientific training for infectious disease screening (AIDS, syphilis, hepatitis B and C, HTLV 1+ 2, toxoplasmosis, rubella, cytomegalovirus) for population and prenatal screening programs. aNEONATAL SCREENINGEquipment, chemical and biological reagents, logistical and scientific training for beta-thalassemia, hemoglobinopathies, immunological and enzymatic disorders and infectious diseases screening in newborns. A

Bio-Oxford

● Tests for General Population Screening

● Tests for Prenatal Screening

● Tests for Newborn Screening

Blood samples collected on filter paper S&S903

SolutionsQ-Preven

● Concept: Large population screening;

● Objective: 100% of the population;

● Method: Dried blood samples collected on filter paper (ELISA)

Business Philosophy

Aim:Expedite access to patientsIdentify epidemiological profile

Procedures for collecting blood on filter paper

See sample enclosed

Access Practicality Prevention Innovation Economy

Advantages


• Epidemic moves to the interior

•Need for laboratory infrastructure in remote areas

• Filter paper carries the laboratory structure of urban centers to regions of difficult access.

Advantages

• Easy method for sample collection -Whole blood

•Optimum solid support for antibodies•Low volume and little invasive •(50ul/spot)

•Transportation (non-infectious)• Simple storage at room temperature• Optimum stability


Advantages


•Facilitates diagnosis and, as a result:

• Immediate treatment and reduction of serious cases

• Increased opportunities for prevention • Reduction of costs of service

Advantages


• This method can be integrated into:

•The rural indigenous population

•The Family Health Program

Advantages

Advantages


• Cost reductionTransportStorageEquipment

Material- Syringe needle-Collection tubes- Power (no centrifugation)

Logistics Serum Filter paper

Extraction Syringe Lancet

Preparation Centrifuge -

Conservation Controlled temperature(Ice) Room

Transport Styrofoam(Ice) Envelope

Personnel Specialized Simple treatment

The Advantages of Filter Paper vs. the Serum Method

Government studies show that, in Brazil, every AIDS patient costs US$4.500 per year, just for drugs. “Interview with Dr. Paulo RobertoTeixeira, Coordinator of the National STD/AIDS Department, Ministry of Health. Dr. Teixeira is a public health doctor and dermatologistand follows the AIDS issue from its inception.” Source: Boa Saúde UOL.

1. Dried blood samples on filter paper are easy to collect, transport and store.

2. Results equivalent to those from the alternative testing method in serum.

3. An excellent solution for areas with no structure or with precarious laboratory structure.

4. Studies by Brazilian institutions show that, contrary to the syringe collection method, dried blood samples on filter paper maintain their properties under extreme temperature conditions such as 51oC, even when combined with high humidity.

Summary

Summary

In the Ministry’s assessment, of the 630,000 persons infected in Brazil, 255,000 who carry the virus have still not taken the test

• SECRETARIA DE VIGILÂNCIA EM SAÚDE• Normative instruction SVS/MS No. 151, October 14, 2009• Official Gazette October 16, 2009• LIST OF REASONS• ...“Brazil is going to update the standards for performing anti-HIV tests. The purpose is to

include the most modern methods to increase the options for performing the exams at laboratories from the public and private systems in Brazil.”

• The main change proposed by the STD/AIDS Department is meant to make testing to diagnosis HIV in the laboratory quicker.

• The new document could also open the way for the first time for doing tests with dried blood, using the filter paper collection. The main advantage of the method is the ability to store blood samples for up to 12 weeks without refrigeration. This methodology, due to its easiness, doesn’t need specialized collection and transport, and, consequently, lowers the cost of exams. Another advantage is that the method allows for sending material by mail, taking the diagnostic method from the urban centers to more distant locations where there is no available laboratory capacity. Technically, the dried blood samples are not considered biologically infectious, which facilitates handling and transportation.

“HIV infection in the pediatric population is

a growing problem, mainly in developing

countries hit by the AIDS epidemic.

The most frequent means for children to

become HIV-positive is through their

mothers, during pregnancy, labor or

breastfeeding.

The Importance of Prevention

In the 21st century, the perinatal HIV epidemic

remains out of control in many countries of the

world. The Joint Program of the United Nations for

HIV/AIDS (UNAIDS) estimates that 40 million people

are living with HIV/AIDS, 5 million people are

infected every year, of whom nearly 3 million are

children; of these, 500,000 die as a result of infection

and 700,000 will acquire new infections in that year,

and many of them will be dead before reaching

adolescence.


Whatever the disease, it is always better to identify it in the pre-

symptomatic phase or in its early stages. This is the reason why

programs that aim at prevention and early diagnosis of various

pathologies are the main objective of current health initiatives. The

main purpose of these educational and prevention initiatives is to

provide all subsidies to publicize the information necessary to

reduce the rates of infection and mortality.

For example, treatment of syphilis, a disease that can cause

blindness or even death in newborns, can be done with a single dose

of benzathine penicillin in primary cases, or up to three doses (one

per week), in cases of latent or secondary syphilis.


These initiatives can be applied to:

• General Screening Programs: For men and women, for

screening of diseases such as AIDS, syphilis, Chagas disease

and hepatitis B and C.

• Prenatal Screening Programs: To detect infectious disease

in women before or during pregnancy.

• Newborn Screening Programs: Screening (heel prick test)

in newborns.


The importance of diagnostic tests to detect infectious diseases has

been widely publicized by the Brazilian government, and various

prevention programs have become mandatory in Brazil, such as the

newborn screening program which is performed on all children born

in the country.

Programs with this scope, given their magnitude, can only be

implemented using filter paper to collect samples.

These programs, as well as the use of filter paper, were the subjects

of reports, such as the two annexed to this presentation, which were

broadcast on the Brazilian TV news program with the largest

audience, with a statement by the Brazilian Minister of Health.


From 1980 to June 2009*, 544,846 AIDS cases were registered in Brazil. During this period,there were 217,091 deaths due to this disease. Every year, 33,000 to 35,000 new cases ofAIDS are reported. In relation to HIV, the estimate is that there are 630,000 infectedpeople in the Brazil.

The epidemic grew inland. From 1997 to 2007, the incidence in cities with fewer than50,000 inhabitants doubled, showing that the epidemic has moved inland. In 1997, therate in cities with under 50,000 inhabitants was about eight times less than that reportedfor cities with over 500,000 people. In 2007, this ratio dropped to three times.

Excerpted from:Boletim Epidemiológico Aids/DST 2009Ministério da Saúde

AIDS in Brazil

Around 1 million new cases of syphilis are reported every year in Brazil, according to estimates fromthe Ministry of Health. After AIDS, the sexually transmitted disease of most concern to doctors issyphilis, mainly due to the transmission from mother to child.

From 1998 to June of 2009, 55,124 cases of congenital syphilis (transmitted from mother to child)were reported in those younger than one year of age in Brazil. On average, 5,000 cases are reportedevery year. The Ministry of Health estimates, however, that there should be 12,000 reports annually.

Beginning in 2005, cases of syphilis in pregnant women also began to be reported. From the beginningof notification up to 2008, 19,608 cases of pregnant women with syphilis were reported, with 6,955just in the last year – the estimate is that around 48,000 pregnant women contract syphilis annually.

From the perspective of public health, the main challenge in fighting syphilis is the verticaltransmission. During pregnancy, the disease can cause miscarriage and death of the fetus. Itscongenital manifestations include deformed bones, deafness, blindness and neurological problems,among others, for children.


Syphilis

The chances of vertical transmission of congenital syphilis canbe eliminated and HIV infection can drop to 1%, if adequateprevention and treatment measures are adopted.


What Bio-Oxford provides:

1- Know-How:

Bio-Oxford has been operating in the

Brazilian market for over ten years, and has

experience and extensive knowledge on

the implementation, management and

control of population screening programs

destined to detecting infectious diseases

and disorders in newborns.

Population Screening Program for Infectious Diseases


2- Automated and/or semi-automated equipment:High technology equipment for processing of results, duly certified by the major publichealth agencies in the world, such as the FDA and the EC.All the equipment will be transferred under a loan scheme, with no additional cost tothe program.

3- Specialized technical assistance for equipment maintenance and repair.



4- Collection kit: All the material needed to collect samples of blood (model enclosed).

5- Operational Training for Sample Collection:Training of the process multipliers in the use and care of the materials provided for the collection, storage, handling and transport of the samples.



6 – Chemical and Biological Reagents: Reagents needed to process samples, tested and approved by international public health agencies.

7 - Scientific Training: training laboratory personnel in methods, equipment and accessory operation, and interpretation of the results of processing the blood samples collected.



8- Web-based Management Program: Program for remote access to results based in the web, with access protected by individual password. (model enclosed).

Ex: www.centrodegenomas.com.br

Login: l (small “L”) 970

Password: bio970


Bio-Oxford also has scientific knowledge, equipment

and reagents to carry out several other programs and

tests, such as:

A – Prenatal tests to detect:AIDS, Syphilis, Hepatitis B and C, HTLV 1 +2, Toxoplasmosis, Rubella, Cytomegalovirus (CMV)


B – Tests for Newborns to identify disorders:

Newborn screening

Tests Disease

Total Thyroxin (T4) Congenital hypothyroidism

Thyroid-stimulating hormone (TSH) Congenital hypothyroidism

PKU enzyme test Phenylketonuria

17-α-Hydroxyprogesterone (17-OHP) Congenital Adrenal Hyperplasia

Enzymatic galactose test Galactosemia

Immunoreactive Trypsin (IRT) Cystic fibrosis

Screening for hemoglobin disorders and thalassemia

Hemoglobin disorders and thalassemia

Bio Oxford

Health & Medicine

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