- Framework agreement with Global Fund strengthens access
to HIV diagnostics
PLEASANTON, California,
June 18, 2015 /PRNewswire/
-- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it
has been selected to provide HIV-1 viral load and early infant
diagnostic technologies for the Global Fund. This marks a further
step in the collaboration between Roche and the Global Fund, an
organization that has pioneered providing effective and economic
solutions for healthcare to achieve the best results for
patients.
"We are proud to be chosen as a supplier for the Global Fund and
to continue to provide reliable HIV-1 diagnostics where they are
needed most," said Paul Brown, Head
of Roche Molecular Diagnostics. "Leveraging our vast number of
systems already installed around the world and continuing to work
with organizations such as the Global Fund, we expand our
commitment to healthcare solutions which make a real difference in
those regions most impacted by HIV."
The HIV-1 tests1 eligible for the Global Fund
collaboration utilize a unique dual-target design to simultaneously
amplify and detect two separate regions of the HIV-1 genome, which
are not subject to selective drug pressure. This innovative
fully-automated solution will provide reliable results for
laboratories and physicians to more confidently and efficiently
treat HIV-1 patients undergoing therapy. For early infant
diagnostics, the dual-target HIV-1 qualitative test,
v2.02 works with both plasma and dried blood spot (DBS)
collection cards, eliminates the need for refrigeration,
drastically reduces the volume of blood required and makes sample
collection and transportation easy, even from the smallest infant
in the most rural area.
In 2014, Roche announced the Global Access Program in
partnership with the Joint United Nations Programme on HIV/AIDS
(UNAIDS), the Clinton Health Access Initiative (CHAI), the
President's Emergency Plan For AIDS Relief (PEPFAR) and the Global
Fund to fight AIDS, TB & Malaria. With this program, Roche
continues its commitment towards the UNAIDS 90/90/90/ goals and an
AIDS-free generation, unmatched in the marketplace by providing
efficient solutions to the unique challenge of expanding HIV-1
diagnostics.
About Global Fund
The Global Fund is a 21st-century partnership designed to
accelerate the end of AIDS, tuberculosis and malaria as epidemics.
As a partnership between governments, civil society, the private
sector and people affected by the diseases, the Global Fund
mobilizes and invests nearly US$4
billion a year to support programs run by local experts in
countries and communities most in need. By challenging barriers and
embracing innovative approaches, partners are working together to
end these epidemics.
About Roche's tradition of commitment to HIV care
Roche has been at the forefront of achievements for HIV and a
global market leader in HIV viral load testing since the
introduction of PCR-based HIV viral load testing in the mid
1990s. In 1998, at the International AIDS Conference in
Geneva, Roche inaugurated the
Global Surveillance Program. Initially designed to monitor changes
in the HIV-1 genomic sequence, the Program and its database have
since expanded to include thousands of genomic sequences for
multiple viruses, including HCV, HBV and WNV, in the world's most
relevant geographic regions. The Program's efforts have played
a monumental role in helping to maintain, and improve, the
reliability of molecular assays.
Roche reinforced its commitment in 2002 with the AmpliCare
Initiative. Roche partnered with national governments, local
healthcare facilities, communities and international agencies,
including the Clinton Health Access Initiative (CHAI) and Centres
for Disease Control (CDC), to establish programs that would go
beyond providing diagnostic tests. The AmpliCare Initiative was a
proactive response to the enormous humanitarian challenge of
HIV/AIDS and TB. Since its inception in 2002, the program has
increased access to HIV viral load tests at substantially reduced
prices in sub-Saharan Africa and countries where the disease burden
is highest.
Most recently, as part of its commitment towards an AIDS free
generation and in support of the UNAIDS 90/90/90/ goals, Roche
announced the Global Access Program for HIV viral load testing.
This program, will greatly help drive viral load testing scale-up
in countries with the highest disease burden.
About the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test,
v2.0
The COBAS® AmpliPrep / COBAS® TaqMan® HIV-1 Test, v2.0 is the
first dual-target test to be offered on the COBAS® AmpliPrep /
COBAS® TaqMan® System. The test has been designed to detect all
HIV-1 (Group M and O) strains even in the presence of potential
HIV-1 mutations.
It is critical for viral load monitoring tests to be able to
quantify very low and high levels of virus, an indicator of the
need for more or less aggressive treatment. The test is highly
sensitive and has a broader dynamic range than previous generation
tests with the ability to detect the World Health Organization
HIV-1 RNA Standard in EDTA plasma as low as 20 copies per
milliliter of patient sample up to 10 million copies/mL. This
innovative fully-automated solution will provide reliable results
for laboratories and physicians to more confidently and efficiently
treat HIV-1 patients undergoing therapy.
The test is designed for use on the fully-automated, real-time
PCR platform, providing sample-in/results-out capability. The
COBAS® AmpliPrep / COBAS® TaqMan® System is flexible and
customizable to meet the space and workflow needs of any
laboratory. In 2005, Roche received CE Mark certification for the
full viral load monitoring menu (HIV-1, HBV, and HCV) on the
system.
About the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative
Test, v2.0
The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative Test,
version 2.0 is an in vitro diagnostic, total nucleic acid
amplification test for the qualitative detection of Human
Immunodeficiency Virus Type 1 (HIV-1) DNA and RNA (or total nucleic
acid, TNA) in human plasma or dried blood spots using the COBAS®
AmpliPrep Instrument for automated specimen processing and the
COBAS® TaqMan® Analyzer or COBAS® TaqMan® 48 Analyzer for automated
amplification and detection.
The test is a diagnostic test, indicated for individuals who are
suspected to be actively infected with HIV-1. Detection of HIV-1
DNA is indicative of active HIV infection. Infants born to mothers
infected with HIV-1 may have maternal antibodies to HIV-1, and the
presence of HIV-1 nucleic acid in the infant indicates active HIV-1
infection. In adults, the test may be used as an aid in the
diagnosis of HIV-1 infection.
About HIV-1
Accordingly to the World Health Organization (WHO), there were
35 million people living with HIV around the world in 2012. That
same year 2.5 million people became newly infected with HIV
worldwide.3 In the most impacted region of Sub-Saharan
Africa, nearly 1 in every 20 adults are HIV-positive.
The transmission of HIV from an HIV-positive mother to her child
during pregnancy, labor, delivery or breastfeeding is called
vertical or mother-to-child transmission (MTCT). In the absence of
any interventions, HIV transmission rates are between 15-45%.
Accurate diagnosis, highly active antiretroviral treatment
(HAART) and viral load testing, a test to determine the amount of
circulating HIV, have contributed to a steady increase in life
expectancy for HIV infected people of 13
years.4
About Roche
Headquartered in Basel,
Switzerland, Roche is a leader in research-focused
healthcare with combined strengths in pharmaceuticals and
diagnostics. Roche is the world's largest biotech company, with
truly differentiated medicines in oncology, immunology, infectious
diseases, ophthalmology and neuroscience. Roche is also the world
leader in in vitro diagnostics and tissue-based cancer diagnostics,
and a frontrunner in diabetes management. Roche's personalised
healthcare strategy aims at providing medicines and diagnostics
that enable tangible improvements in the health, quality of life
and survival of patients. Founded in 1896, Roche has been making
important contributions to global health for more than a century.
Twenty-eight medicines developed by Roche are included in the World
Health Organization Model Lists of Essential Medicines, among them
life-saving antibiotics, antimalarials and chemotherapy.
In 2014, the Roche Group employed 88,500 people worldwide,
invested 8.9 billion Swiss francs in
R&D and posted sales of 47.5 billion
Swiss francs. Genentech, in the
United States, is a wholly owned member of the Roche Group.
Roche is the majority shareholder in Chugai Pharmaceutical,
Japan. For more information,
please visit www.roche.com.
All trademarks used or mentioned in this release are protected
by law.
For media inquiries
please contact:
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Bob Purcell
Roche Molecular Diagnostics
888-545-2443
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Florian Beer,
Austria
+ 43 -1 - 27 787 – 496
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Silvia Zucca,
Italy
+39 039 2817 612
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Francisco
Aguilar-Alvarez, Spain
+34 93583
4011
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Eudes de Villiers,
France
+33 4 76 76 31 26
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Banu Kutlu,
Turkey
00902123060606
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Harald Borrmann,
Switzerland
+41 41 799
6253
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Kate Hoile,
UK
+44 1444
256591
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Jan Schreiber,
Germany
+49 621 759
5156
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1 COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0
and COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative Test,
v2.0
2 COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative
Test, v2.0
3 The UNAIDS Report on the Global AIDS Epidemic
2012.
4 Lancet. Volume 372, Issue 9635, 26 July 2008-1
August 2008, Pages 293-299.