bioLytical Laboratories Gets Added HIV-2 Indication for HIV Test

Point-of-care rapid diagnostics maker bioLytical Laboratories got a green light from the FDA for its INSTI HIV Antibody Test for detecting HIV type 2 antibodies. With this added indication, the test can now detect both HIV-1 and HIV-2 antibodies in as little as 60 seconds, the Canadian firm said Tuesday.

The new claim will also allow bioLytical to expand its U.S. reach, as some health departments require both antibody types for their testing programs, said Rick Galli, chief technical officer.

The FDA approval includes a CLIA waiver that permits the test to be administered by a qualified individual outside of a laboratory setting. This is important to global testing initiatives, the company said, as it improves access to people who might not get tested by a healthcare provider, those testing for the first time and those at highest risk of acquiring HIV.

The Centers for Disease Control and Prevention estimates that more than 1.2 million people in the U.S. are living with HIV — 168,000 of whom are unaware of their infection. — Kellen Owings