OraSure Technologies, the maker of the OraQuick Advance® Rapid HIV-1/2 Antibody Test, will soon be petitioning the U.S. Food and Drug Administration (FDA) to approve the assay for over-the-counter availability and home HIV testing. The manufacturer plans to partner with another company, Constella Group LLC, to provide vital counseling and referrals to consumers of the test.
At present, HIV testing requires the direct involvement of medical professionals and/or counselors, usually at a doctor's office, clinic, hospital, or other established testing site. While there are home-collection kits – including The Home Access® HIV-1 Test System – the samples must be shipped to a Home Access Corporation laboratory for testing, with the results reported via telephone within three to seven days. OraSure Technologies is now looking to win approval of the first rapid HIV testing system – producing results within 20 minutes – that can be purchased and conducted by consumers.
OraSure has been conducting clinical studies and developing new packaging and labeling as it prepares to submit an application to the FDA for approval of the over-the-counter test. However, a critical component of the ongoing development of this product is the incorporation of a consumer counseling system. On April 2nd, OraSure announced that it had signed an agreement with Constella to develop this necessary component. For the past five years, Constella has operated the U.S. Centers for Disease Control (CDC) nationwide HIV/AIDS clearinghouse and call center.
Under the agreement, Constella will develop a counseling system that is fully compliant with both FDA and international regulatory and quality standards. The system will offer phone and website access 24 hours a day, seven days a week to assist consumers who use the OraQuick assay and, when necessary, provide medical referrals.
OraSure has completed various laboratory studies as preliminary steps towards obtaining FDA approval of an OTC HIV test. The supporting clinical trials will continue throughout 2007 and into 2008, after which the company plans to submit an application for FDA approval.
Source:
OraSure Technologies, Inc.
