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 in the United States. This development comes at a critical time for HIV prevention efforts, 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 do not know they have the virus, with over 30,000 new infections occurring annually in the U.S.
Robert Mackie, CEO of bioLytical, emphasized that HIV testing should be simple, fast, and accessible for everyone. The test's 60-second results empower people to take control of their health without waiting for clinic appointments or laboratory results. The discreet and portable design allows testing anywhere, anytime, addressing barriers to traditional healthcare such as stigma, cost, or geographical limitations.
Early detection through rapid testing improves treatment outcomes and significantly reduces transmission risk. The INSTI® HIV Self Test requires just a single drop of blood from a fingertip and provides highly accurate results, reducing the anxiety associated with waiting for test outcomes. This advancement supports national public health objectives, including the goal of reducing HIV infections by 90% by 2030 as part of the Ending the HIV Epidemic initiative detailed at https://www.cdc.gov/endhiv.
Ana Subramanian, Vice President of Scientific Affairs at bioLytical, noted that the FDA approval reflects both the scientific integrity of their work and their commitment to expanding access to rapid, reliable diagnostics. The test will be manufactured in bioLytical's state-of-the-art facility under their MDSAP: ISO 13485:2016 Quality Management System, ensuring high quality standards. As statistics from https://www.hiv.gov highlight the ongoing challenge of HIV in the U.S., this self-test represents a practical tool to increase testing frequency and accessibility.
The INSTI® HIV Self Test will soon be available at major retailers and online, providing a private, reliable option for individuals to learn their HIV status. By breaking down testing barriers, this innovation helps connect people to care sooner and supports broader public health efforts to reduce undiagnosed cases across the country.
