Alere to Develop Simple, Affordable Point-of-Care Nucleic Acid Test for Tuberculosis & Expand Manufacturing for POC HIV Viral Load Platform

Fri Mar 1, 2013 7:00am EST

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WALTHAM, Mass.,  March 1, 2013  /PRNewswire/ -- Alere Inc. (NYSE: ALR) announced
today that it has been awarded a grant of up to  $21.6 million  and debt
financing of up to  $20.6 million  from the Bill & Melinda Gates Foundation. The
 $21.6 million  grant will fund the development of a tuberculosis assay, which
will be designed for use in both resource-constrained and well-resourced
settings. It will also support the company's efforts to incorporate one of its
isothermal amplification technologies for TB detection onto the Alere Q, a
compact, portable, and robust device intended for molecular testing at the point
of care. In addition, the Gates Foundation will provide below-market loans of up
to  $20.6 million  for the expansion and scale up of Alere's manufacturing
facilities in Jena,  Germany  for both the POC TB Nucleic Acid Test and the POC
HIV Viral Load Test currently in the final stages of development. The Gates
Foundation will provide these loans in exchange for commitments from Alere to
make these diagnostics available at an affordable price to people in need in
developing countries.  

Tuberculosis is a leading cause of death worldwide, and nearly 8.8 million cases
of TB occur each year, mostly in middle-income and low-income countries. Today,
laboratory-based technologies provide the primary means for diagnosing the
illness, but these technologies often fail to identify large numbers of active
cases, take weeks to deliver results, lack crucial drug resistance information,
or are unable to meet the needs of individuals with limited access to lab
facilities. Alere's collaboration with the Gates Foundation will produce a
highly sensitive, low-cost diagnostic that can be implemented in lower-level
laboratories or outside the lab altogether.

A world leader in near-patient diagnostics, Alere is committed to developing
solutions that support screening for the world's most burdensome diseases, such
as TB and HIV, and support the ongoing monitoring of people living with HIV or
HIV-related conditions like TB.

Alere will deploy a previously acquired isothermal amplification technology for
TB detection and is developing a molecular device, the Alere  Q, which is
currently in clinical trials, to support near-patient molecular testing for HIV.
Merging these technologies in a single platform will play an invaluable role in
combating the TB epidemic. The platform will offer the high-performance
sensitivity and specificity needed to diagnose individuals with TB accurately.
Moreover, it may be used for strain and antibiotic resistance typing at the
point of care, which should ultimately serve to improve patient management and
fight the spread of drug-resistant strains. Compact design, battery-powered
portability, and ease of use will make the Alere  Q ideal for even the most
basic healthcare settings.

Furthermore, Alere's highly automated manufacturing processes will ensure that
both the instrument platform and consumables can be produced at an accessible
price that enables widespread adoption. Since the introduction of its
revolutionary Alere CD4 product in 2010, Alere has built the manufacturing site
in Jena,  Germany, into a center of excellence for instrument-based,
point-of-care diagnostics. As part of the agreement, HIV test manufacturing will
be fully automated and scaled to the level needed to make the product globally

Commenting on the award, Alere CEO  Ron Zwanziger  said, "Providing affordable
products that transform the way medicine is practiced, especially in
resource-limited settings, is part of Alere's heritage.  There is a critical
need for near-patient diagnostics that accurately identify TB cases and
facilitate effective management to keep the condition under control. We are very
excited to have the support of the Gates Foundation in fighting one of the most
dangerous infectious diseases, and we remain committed to providing solutions
that improve health outcomes for individuals living with HIV."

"Although significant progress has been made in combating tuberculosis over the
past 25 years, it remains one of the leading causes of death worldwide.  To
provide earlier treatment and prevent the spread of TB, we need fast, accurate
diagnostic tools that can be easily implemented in resource-limited
environments," said  Bill Gates, co-chair of the Bill & Melinda Gates
Foundation.  "Alere has a track record of diagnostic innovation and leveraging
cost-effective technologies to improve health outcomes for individuals living
with HIV in the most remote parts of the world. The Gates Foundation has put its
support behind the company to apply these same principles in addressing the TB
epidemic and potentially saving millions of lives."

Development on the TB assay has commenced, and validation for its use is
expected within the next 24 months.  

About Alere  

By developing new capabilities in near-patient diagnosis, monitoring and health
information technology, Alere enables individuals to take charge of improving
their health and quality of life at home. Alere's global leading products and
services, as well as its new product development efforts, focus on cardiology,
infectious disease, toxicology and diabetes. Alere is headquartered in  Waltham,
Massachusetts.  For more information regarding Alere, please visit

SOURCE  Alere Inc.

Doug Guarino, Director of Corporate Relations, +1-781-647-3900

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