A 20-minute, non-invasive, in home HIV test may soon be available for consumers to use at home to determine their HIV status.
On Tuesday, the U.S. Food and Drug Administration (FDA) Blood Products Advisory Committee (BPAC) voted unanimously to approve the OraQuick In-Home HIV Test developed and manufactured by Bethlehem, PA company, OraSure Technologies.
The 17-member panel, which reviews and evaluates biotechnology products and their safety, advises the FDA. The regulatory agency is expected to make a final decision sometime this year.
According to an OraSure Technologies press release Tuesday, the BPAC voted on two questions posed by the FDA:
1. Do the projected benefits of the test outweigh the potential risks of false positive and false negative test results? The committee voted 17-0 in the affirmative to that question.
2. Do the available data provide reasonable assurance that the test is safe and effective for its intended use? The committee voted 17-0 in the affirmative to that question.
If approved, the OraQuick® In-Home HIV Test will be the over-the-counter version of the OraQuick ADVANCE® Rapid HIV-1/2 Test, which is a 20-minute , rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in oral fluid used in clinical settings like hospitals and doctor’s offices.
"We are pleased with the outcome of today's Blood Products Advisory Committee meeting," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "There was broad support expressed by the HIV community at today's meeting and we look forward to continuing our work with them in the fight against HIV. We believe the OraQuick® In-Home HIV Test will make a valuable contribution in this fight."
The rapid test available at home would has the potential to reduce the number of people who unknowingly spread the virus because they’re unaware they’re infected.
The Centers for Disease Control and Prevention (CDC) says:
· More than 1.1 million people in the U.S. are infected with HIV and 232,700 don’t know it.
· These uninformed people cause 54-70% of the 56,300 new infections annually.
· 75% of HIV+ people will change risky behaviors when they learn their status.