FDA Approves One-Minute INSTI® HIV Self Test, Accelerating National HIV Prevention Efforts

The U.S. Food and Drug Administration has approved the INSTI® HIV Self Test from bioLytical Laboratories Inc., making it the first one-minute HIV self-test available to American consumers. This approval marks a substantial advancement in HIV testing accessibility, offering individuals a private, reliable method to learn their HIV status without the need for clinic appointments or laboratory processing delays.

HIV remains a serious public health challenge in the United States, with an estimated 1.2 million Americans living with HIV and approximately 13% unaware of their status. Most new HIV infections originate from individuals who don't know they have the virus, with over 30,000 new infections occurring annually. The INSTI® HIV Self Test addresses these challenges by providing highly accurate results in just 60 seconds using a single drop of blood from a fingertip, making it the fastest home-use HIV rapid test available.

The test's discreet and portable design allows people to test for HIV anywhere, anytime, overcoming barriers to traditional healthcare that many face due to stigma, cost, or geographical limitations. Robert Mackie, CEO of bioLytical, emphasized that "HIV testing should be simple, fast, and accessible for everyone. By offering accurate results in just 60 seconds, we are empowering people to take control of their health, without waiting for clinic appointments or lab results."

This development supports the national public health goal of Ending the HIV Epidemic (EHE), which aims to reduce HIV infections by 90% by 2030. Early detection through rapid testing improves treatment outcomes and significantly reduces transmission risk, making expanded testing access critical to achieving this objective. The test will be available soon at major retailers and online, with updates and purchasing details available through bioLytical's website.

Ana Subramanian, Vice President of Scientific Affairs at bioLytical, noted that "The FDA approval of the INSTI® HIV Self Test reflects both the scientific integrity of our work and our commitment to expanding access to rapid, reliable diagnostics. This milestone ensures that more people across the U.S. can confidently access accurate HIV testing when and where they need it most." The company will manufacture the test in its state-of-the-art facility, maintaining high quality standards through its MDSAP: ISO 13485:2016 Quality Management System.

By breaking down barriers to testing, the INSTI® HIV Self Test represents a powerful tool in the fight against HIV, providing immediate answers when they matter most and helping connect people to care sooner. This advancement in self-testing technology supports broader public health efforts by reducing undiagnosed HIV cases and expanding screening opportunities across diverse populations.