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1. Population Screening Program and Prenatal

2. Bio-Oxford
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.

3. Bio-Oxford
Bio-Oxford has expertise and works in all segments of the in vitro diagnostics market with a focus and leadership
position in:
POPULATION AND PRENATAL SCREEENING
Equipment, 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.
a
NEONATAL SCREENING
Equipment, chemical and biological reagents, logistical and scientific training for beta-thalassemia,
hemoglobinopathies, immunological and enzymatic disorders and infectious diseases screening in newborns.
A

4. Solutions
Q-Preven
● Tests for General Population Screening
● Tests for Prenatal Screening
● Tests for Newborn Screening
Blood samples collected on filter paper S&S903

5. Business Philosophy
● Concept: Large population screening;
● Objective: 100% of the population;
● Method: Dried blood samples collected on filter paper
(ELISA)
Aim:
Expedite access to patients
Identify epidemiological profile

6. Procedures for collecting blood on filter paper
See sample enclosed

7. Advantages
Access Practicality Prevention Innovation Economy

8. Advantages
Access Practicality Prevention Innovation Economy
• 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.

9. Advantages
Access Practicality Prevention Innovation Economy
• 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

10. Advantages
Access Practicality Prevention Innovation Economy
•Facilitates diagnosis and, as a result:
• Immediate treatment and reduction of
serious cases
• Increased opportunities for prevention
• Reduction of costs of service

11. Advantages
Access Practicality Prevention Innovation Economy
• This method can be integrated into:
•The rural indigenous population
•The Family Health Program

12. Advantages
Access Practicality Prevention Innovation Economy
• Cost reduction
Transport
Storage
Equipment
Material
- Syringe needle
-Collection tubes
- Power (no centrifugation)

13. The Advantages of Filter Paper vs. the Serum Method
Logistics Serum Filter paper
Extraction Syringe Lancet
Preparation Centrifuge -
Controlled temperature
Conservation Room
(Ice)
Styrofoam
Transport Envelope
(Ice)
Personnel Specialized Simple treatment
Government studies show that, in Brazil, every AIDS patient costs US$4.500 per year, just for drugs. “Interview with Dr. Paulo Roberto
Teixeira, Coordinator of the National STD/AIDS Department, Ministry of Health. Dr. Teixeira is a public health doctor and dermatologist
and follows the AIDS issue from its inception.” Source: Boa Saúde UOL.

14. Summary
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.

15. 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

16. • 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.

17. The Importance of Prevention
“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.

18. 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.

19. The Importance of Prevention
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.

20. The Importance of Prevention
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.

21. The Importance of Prevention
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.

22. AIDS in Brazil
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 of
AIDS are reported. In relation to HIV, the estimate is that there are 630,000 infected
people in the Brazil.
The epidemic grew inland. From 1997 to 2007, the incidence in cities with fewer than
50,000 inhabitants doubled, showing that the epidemic has moved inland. In 1997, the
rate in cities with under 50,000 inhabitants was about eight times less than that reported
for cities with over 500,000 people. In 2007, this ratio dropped to three times.
Excerpted from:
Boletim Epidemiológico Aids/DST 2009
Ministério da Saúde

23. Syphilis
Around 1 million new cases of syphilis are reported every year in Brazil, according to estimates from
the Ministry of Health. After AIDS, the sexually transmitted disease of most concern to doctors is
syphilis, 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 reported
every 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 beginning
of notification up to 2008, 19,608 cases of pregnant women with syphilis were reported, with 6,955
just 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 vertical
transmission. During pregnancy, the disease can cause miscarriage and death of the fetus. Its
congenital manifestations include deformed bones, deafness, blindness and neurological problems,
among others, for children.
Excerpted from:
Boletim Epidemiológico Aids/DST 2009
Ministério da Saúde

24. The chances of vertical transmission of congenital syphilis can
be eliminated and HIV infection can drop to 1%, if adequate
prevention and treatment measures are adopted.
Excerpted from:
Boletim Epidemiológico Aids/DST 2009
Ministério da Saúde

25. Population Screening Program for Infectious Diseases
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.

26. Population Screening Program for Infectious Diseases
What Bio-Oxford provides:
2- Automated and/or semi-automated equipment:
High technology equipment for processing of results, duly certified by the major public
health 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 to
the program.
3- Specialized technical assistance for equipment
maintenance and repair.

27. Population Screening Program for Infectious Diseases
What Bio-Oxford provides:
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.

28. Population Screening Program for Infectious Diseases
What Bio-Oxford provides:
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.

29. Population Screening Program for Infectious Diseases
What Bio-Oxford provides:
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

30. Population Screening Program for Infectious Diseases
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)

31. Newborn screening
B – Tests for Newborns to identify disorders:
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 Hemoglobin disorders and thalassemia
thalassemia