Zyomyx Receives $7.5 Million From UNITAID to Launch Rapid, Service-Free Point-of-Care CD4 Test

Quantitative Diagnostic Will Support Expanded Access to HIV Treatment

Fremont, California, UNITED STATES

FREMONT, Calif., March 26, 2014 (GLOBE NEWSWIRE) -- Zyomyx, Inc. has been awarded US$7.5 million from UNITAID to commercialize its quantitative MyT4™ point-of-care CD4 test, designed to guide HIV/AIDS treatment initiation and monitoring in low- and middle-income countries. UNITAID's funding contribution is part of its strategy to speed up access to a range of new and improved technologies from a number of manufacturers for HIV/AIDS, tuberculosis and malaria for the world's most vulnerable populations. It will support field evaluations of the product, training for national HIV programs, and country-level and global regulatory filings. The Zyomyx test is the fastest point-of-care CD4 diagnostic on the market and delivers results that are equivalent to lab-based flow cytometry, the gold standard of CD4 testing. The MyT4™ CD4 test is commercially available receiving a CE Mark in December 2013.

"We are delighted and grateful that UNITAID has recognized the potential of the MyT4™ CD4 test and invested its resources to support its introduction," said Peter Wagner, President and CEO of Zyomyx. "We are fully aligned with UNITAID's approach to address public health issues as well as the market conditions to bring diagnostic technology to those most in need. UNITAID's innovative use of financing and market power to effect change makes it a transformational player in the global health arena."

CD4 count is the critical marker to determine when patients need to start antiretroviral therapy and to monitor the immune status of HIV positive patients. However, there are barriers to testing for people in resource poor settings because traditional lab tests are only available in central locations and require that many patients wait weeks to obtain a result. The quantitative MyT4™ CD4 test provides a result in 10 minutes from a finger-prick sample. The product is the only service-free quantitative test on the market as it does not require any maintenance or swap to a central location for repairs because there is no complex instrumentation. As a result, the cost to adopt the test is minimal compared to thousands of dollars for instrument based platforms.

The MyT4™ CD4 test supports countries' efforts to decentralize HIV treatment, expanding access to healthcare for remote populations and relieving the burden at centralized facilities. According to WHO, there are 9.7 million people in developing countries on antiretroviral therapy today but another 16 million people are unable to access the treatment they need. Point-of-care diagnostic testing is a critical tool to determine treatment eligibility and link greater numbers of HIV positive people to lifesaving treatment.

"To curb the AIDS epidemic, we must expand access to testing and treatment globally," said Ben Plumley, CEO of Pangaea Global AIDS Foundation. "Rapid, affordable and accessible point-of-care CD4 and viral load diagnostics are critical for enabling us to reach vulnerable groups and better identify who needs to initiate or adjust treatment."

The MyT4™ CD4 test is the first of an expanding line of diagnostic tests that originate from Zyomyx's portfolio of proprietary platform technologies capable of moving laboratory tests for cells, proteins and infectious agents to the point-of-care and thereby providing immediate benefits to clinicians, healthcare workers and patients in multiple disease areas.

About Zyomyx, Inc.

Zyomyx, Inc. has developed a proprietary cell capture and analysis platform to enable quick low-cost diagnosis for infectious diseases. The platform is focused on a suite of diagnostics for antibiotic resistance where same day results at the point-of-care have a major impact on treatment outcomes and health care costs. The company's first product, an inexpensive CD4 T-cell point-of-care test, demonstrates the potential of Zyomyx's capture and analysis technology. Zyomyx, which is based in Fremont, California, is privately held. For more information, visit http://www.zyomyx.com.


Based in Geneva and hosted by the World Health Organization, UNITAID uses innovative financing to increase funding for greater access to treatments and diagnostics for HIV/AIDS, malaria and tuberculosis in low-income countries. Approximately half of UNITAID's resources come from a small levy on airline tickets in several countries, while the rest is provided primarily by multi-year contributions from governments and a foundation. As of the end of 2011, this levy has collected US$ 1.06 billion – 66% of the US$ 1.6 billion raised by UNITAID.


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