Manufacturer Attends Meeting on Over-the-Counter HIV Testing November 22
Because of the rather sensitive circumstances that may lead towards being infected by the HIV virus, some people may find the ability to perform an HIV test in the comfort and privacy of their home the more preferable way. Luckily, there are such home test kits that are already available in the market nowadays.
OraSure Technologies, a company that “develops, manufactures and markets oral fluid specimen collection devices using proprietary fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices,” recently announced through a press release featured on CNN Money that it had participated in a meeting conducted by the Blood Products Advisory Committee (BPAC).
The November 17th meeting included a discussion on “the public need and performance characteristics for the over the counter home use HIV test kits.” BPAC is a group that advices the FDA when the “safety and medical effectiveness of biological products and medical devices” are concerned. Also presented was the view of the Centers for Disease Control and Prevention (CDC) regarding the role that these home-based HIV test kits play, as well as the risks and benefits that may be associated with their use.
OraSure was among those who participated in a closed session with the BPAC, during which time OraSure reviewed findings that resulted from clinical studies that it had been conducting with its OraQuick HIV OTC test. Additional clinical work that will be required towards receiving FDA approval was also discussed during the meeting. Feedback received from the meeting will be used as basis for the company’s efforts towards securing FDA approval for OraQuick.
Tags: hiv test kit, home hiv testing, Home Testing