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| Zyomyx's point-of-care MyT4 CD4 test--Courtesy of Zyomyx |
California diagnostic maker Zyomyx pulled in $7.5 million from World Health Organization-hosted UNITAID to support commercialization of its point-of-care HIV/AIDS test in the developing world.
Zyomyx, which last year inked a distribution deal with pharmaceutical giant Mylan ($MYL), touts the ability of its MyT4 CD4 test to deliver results equivalent to flow cytometry from a lab, calling it the "gold standard" of CD4 testing. A CD4 count is used to determine therapeutic options and monitor a patient's immune status. With a finger-prick sample, the test, CE marked in December, is designed to provide a diagnosis within 10 minutes. And the device itself, the company says, requires little maintenance and repairs because of its simple design.
UNITAID's contribution will go to support field evaluations, HIV program training and regulatory filings at the country and global levels, according to the company.
For Zyomyx and Mylan, funding from an organization like UNITAID is instrumental in bringing its low-cost tests to market in areas that lack healthcare infrastructure. Last year, the Bill & Melinda Gates Foundation joined the effort to contribute part of a $12 million funding round, $6 million of which came from Mylan itself. And Mylan, in its first foray into the diagnostics space, promised the foundation that it would sell the test at "a reasonable price" in HIV-burdened countries.
"We are delighted and grateful that UNITAID has recognized the potential of the MyT4 CD4 test and invested its resources to support its introduction," Zyomyx CEO Peter Wagner said in a statement. "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."
The point-of-care test marks an important step in bringing important diagnostic capabilities to vulnerable populations. According to the original distribution deal, Mylan will offer the test along with its generic antiretroviral drugs in areas of Africa, Asia, Russia, the Middle East, South America, Central America and the Caribbean Islands.
"To curb the AIDS epidemic, we must expand access to testing and treatment globally," Pangaea Global AIDS Foundation CEO Ben Plumley said. "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."
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