The U.S. Food and Drug Administration (FDA) has approved the INSTI® HIV Self Test from bioLytical Laboratories Inc., making it the first one-minute HIV self-test available in the United States. This approval marks a significant step forward in HIV prevention by providing a rapid, private, and reliable testing option that can be used at home or on the go.
“HIV testing should be simple, fast, and accessible for everyone,” said Robert Mackie, CEO of bioLytical. “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.” The test requires a single drop of blood from a fingertip and delivers results in 60 seconds or less, reducing the anxiety associated with waiting for test results.
HIV remains a serious public health challenge in the U.S. According to the CDC, an estimated 1.2 million Americans are living with HIV, and approximately 13% of those individuals are unaware of their status. Most new HIV infections come from people who do not know they have the virus, with over 30,000 new infections occurring each year. Early detection improves treatment outcomes and significantly reduces transmission risk. The INSTI® HIV Self Test addresses critical gaps in screening, especially for those who face barriers to traditional healthcare due to stigma, cost, or location.
“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,” said Ana Subramanian, Vice President of Scientific Affairs at bioLytical. “This milestone ensures that more people across the U.S. can confidently access accurate HIV testing when and where they need it most.”
The test is shelf-stable, portable, and designed for discreet use. It will be available soon at major retailers and online; updates can be found on bioLytical's website at https://www.biolytical.com. Expanding testing access is critical to reducing HIV infections by 90% by 2030 as part of the U.S. public health goal of Ending the HIV Epidemic (EHE). Self-testing supports these national goals by reducing undiagnosed HIV cases, expanding screening opportunities, and helping connect people to care sooner.
bioLytical will manufacture the test in its state-of-the-art facility, ensuring high-quality standards through its MDSAP: ISO 13485:2016 Quality Management System. As a global leader in rapid infectious disease diagnostics, bioLytical is committed to expanding access to fast, accurate, and reliable testing solutions. More information is available at https://www.insti.com and https://www.istatis.com.
