OraSure Technologies, Inc. (Nasdaq:OSUR) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's OraQuick In-Home HIV Test for sale directly to consumers in the over-the-counter (OTC) market – making it the first and only rapid OTC HIV test approved in the U.S. The OraQuick® In-Home HIV Test can detect antibodies to both HIV-1 and HIV-2 with an oral swab, providing a confidential in-home testing option with results in as little as 20 minutes. It is the first rapid diagnostic test for any infectious disease that has been approved by the FDA for sale over the counter.
"Approval of the OraQuick® In-Home HIV Test represents a major breakthrough in HIV testing," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "For the first time ever, individuals will have access to an in-home oral test that will empower them to learn their HIV status in the comfort of their home and obtain referral to care if needed. This new in-home rapid test – the same test doctors have used for years – will help individuals at risk for HIV who otherwise may not test in a professional or clinical setting."
The OraQuick® In-Home HIV Test is an over-the-counter version of the Company's OraQuick ADVANCE® HIV 1/2 Antibody Test, the market leading rapid HIV test with millions of units sold to hospitals, clinics, community-based organizations and physician offices.
The OraQuick® In-Home HIV Test is expected to be available for purchase this October at more than 30,000 retail outlets throughout the country and online.
OraSure is committed to providing OraQuick® In-Home HIV customers with extensive resources and support. Each test kit includes detailed information on HIV and HIV testing, including step-by-step directions on how to use the OraQuick® In-Home HIV Test. Customers also have access to a "live" toll-free customer support center and comprehensive consumer website. The support center is staffed with bi-lingual (English/Spanish) representatives who are available by telephone (toll free 866-436-6527) to answer questions about HIV/AIDS, describe how to use the test and interpret the results, and to provide direct referral to care if needed. Support center representatives are available 24 hours a day, seven days a week, 365 days a year and will be active starting on Monday, July 9th. In addition to the support center, a comprehensive consumer website will be launched to provide access to resources and referral to follow-up counseling and medical care. The comprehensive website will launch when product is available in October.
According to the Centers for Disease Control and Prevention (CDC), there are approximately 1.2 million people in the U.S. that have HIV and approximately 240,000 of them are unaware of their status. Those who do not know they are HIV positive are disproportionately responsible for the 50,000 new HIV infections that occur each year.
"We set out with a clear purpose – to dramatically impact the number of people getting tested for HIV nationwide," added Michels. "Today's FDA approval of OraQuick brings us much closer to accomplishing that goal."