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

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

PR Newswire

WALTHAM, Mass., March 1, 2013

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 accessible.

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 www.alere.com.

SOURCE Alere Inc.

Website: http://www.alere.com
Contact: Doug Guarino, Director of Corporate Relations, +1-781-647-3900
 
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