FDA approves 1-minute HIV self-test

The FDA has approved bioLytical Laboratories’ Insti HIV self test. The company touts it as the fastest home-use HIV test available in the U.S., with results in 60 seconds or less.

BioLytical said the test provides a private, portable and highly accurate option for individuals to determine their HIV status without needing appointments or lab visits, according to an Oct. 14 news release.

The single-use test requires one drop of blood and is designed to reduce barriers to HIV screening, particularly for individuals who face stigma, cost or geographic obstacles in accessing care.

BioLytical said the new test supports national goals to reduce HIV infections by 90% by 2030. 

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