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FDA Approves First One-Minute HIV Self-Test in U.S.

FDA approves bioLytical's INSTI HIV Self Test - the first one-minute home HIV test in the U.S. Provides accurate results in 60 seconds, expanding access to private testing.

This development represents a transformative moment in HIV prevention and public health accessibility. The availability of a rapid, accurate, and private self-testing option addresses significant barriers that have historically prevented people from getting tested, including stigma, cost concerns, and limited access to healthcare facilities. For individuals, this means immediate knowledge of their HIV status without the anxiety of waiting days or weeks for results, enabling faster access to treatment if needed and reducing transmission risks. At a population level, increased testing accessibility directly supports national public health goals to end the HIV epidemic by identifying undiagnosed cases and connecting people to care sooner. The convenience and privacy of this testing method could significantly increase testing rates among high-risk populations and those who might otherwise avoid traditional testing settings, ultimately contributing to reduced infection rates and improved public health outcomes across communities.