FDA Approves One-Minute INSTI HIV Self Test in Major Step for HIV Prevention

The U.S. Food and Drug Administration has granted approval to bioLytical Laboratories' INSTI HIV Self Test, marking the first one-minute HIV self-test available to American consumers. This development represents a significant advancement in HIV prevention by offering rapid, private testing that can be conducted anywhere without medical supervision. The test requires just a single drop of blood from a fingertip and delivers highly accurate results within 60 seconds, making it the fastest home-use HIV rapid test on the market.

The timing of this approval aligns with critical public health needs, as HIV remains a serious challenge in the United States with approximately 1.2 million Americans living with HIV and about 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 according to HIV.gov statistics. Early detection through accessible testing improves treatment outcomes and significantly reduces transmission risk, making expanded testing access essential to reducing HIV infections by 90% by 2030 as part of the national Ending the HIV Epidemic initiative detailed by the CDC.

Robert Mackie, CEO of bioLytical, emphasized that HIV testing should be simple, fast, and accessible for everyone. The discreet and portable design of the INSTI HIV Self Test allows people to test privately on their own terms, overcoming barriers to traditional healthcare that often include stigma, cost, or geographical limitations. This accessibility is particularly important for reaching populations who might otherwise avoid testing due to privacy concerns or healthcare access challenges.

Ana Subramanian, Vice President of Scientific Affairs at bioLytical, noted that the FDA approval reflects both the scientific integrity of their work and the company's commitment to expanding access to rapid, reliable diagnostics. The test's key benefits include its ultra-fast results, high accuracy, convenience as a shelf-stable portable option, and complete privacy since no appointments are required. The INSTI HIV Self Test will soon be available through major retailers and online channels, providing widespread access to this innovative testing solution that supports national public health goals by reducing undiagnosed HIV cases and helping connect people to care sooner.