One Company Takes Next Step to Getting In-Home HIV Test to Market

Medford, NY (I-Newswire) June 27, 2011 - This date marks National HIV Testing Day (6/27), an event whose theme is “Take the Test, Take Control.” The message is urgent in the wake of a new USA TODAY analysis of data from the Centers for Disease Control and Prevention: Many states with the most serious HIV epidemics—including Florida, New York, Texas, Georgia, and New Jersey—are home to large numbers of infected people who go undiagnosed. According to the CDC, about 20 percent of Americans with HIV don’t know it, greatly increasing their risk of transmitting the virus.

One company with a keen interest in the magnitude of this crisis is New York-based Chembio Diagnostics, Inc., a New York-based developer and manufacturer of point-of-care diagnostic tests. Chembio is now taking the next step to expand Americans’ HIV testing options. The company already has two FDA-approved rapid HIV tests for the point-of-care market; in as little as 15 minutes, these can provide an accurate (99.7% sensitivity) indication of the presence of antibodies that are associated with the presence of HIV.

Yet many at-risk individuals may prefer to self-administer an HIV test in the privacy of their own home, instead of going to a healthcare facility. For the benefit of this segment of the population, which might otherwise go untested, Chembio is now taking the first step toward getting its FDA-approved Sure Check® HIV test—which is marketed by its US marketing partner Alere as Clearview® Complete HIV 1/2—approved for over-the-counter (OTC) use.

“The Sure Check® HIV test product is a finger-stick whole blood test that we envision will provide an important alternative means for individuals to know their HIV status,” says Lawrence Siebert, Chembio’s CEO. “Sure Check® is unique in its ease of use for people at home. We also believe that many people may be more willing to trust the results of an HIV test involving a blood sample rather than an oral fluid sample, and we want to provide that option at least.”

A great deal of technical innovation lies behind the simplicity and ease of use of the Chembio Sure Check® HIV test device which incorporates an on-board sample collection system and unitized buffer system that together create a closed device as a result of completing the test procedure. Further information and a demo of the product can be viewed at http://www.chembio.com/humantest3.html.

The first step toward the test’s OTC approval is for Chembio to submit an investigational device exemption (IDE) to the US Food and Drug Administration. The IDE application for an over-the-counter HIV test must include two separate studies, including a market study of the test’s intended users. Chembio plans to submit the IDE to the FDA before the end of the year.

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