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

The U.S. Food and Drug Administration has approved bioLytical Laboratories' INSTI® HIV Self Test, marking the first one-minute HIV self-test available to American consumers. This approval represents a critical advancement in HIV prevention efforts at a time when approximately 13% of the 1.2 million Americans living with HIV remain undiagnosed, according to HIV.gov statistics.

The INSTI® HIV Self 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 available. This rapid turnaround time significantly reduces the anxiety associated with waiting for test results while providing immediate answers about HIV status. The test's portable and discreet design allows individuals to test privately at home or any location of their choosing, eliminating barriers posed by traditional healthcare settings.

Robert Mackie, CEO of bioLytical, emphasized the importance of accessible testing, stating that HIV testing should be simple, fast, and available to everyone. The company's approach aims to empower people to take control of their health without requiring clinic appointments or waiting for laboratory results. This expanded accessibility aligns with national public health objectives, particularly the Ending the HIV Epidemic initiative that seeks to reduce new HIV infections by 90% by 2030.

The timing of this FDA approval is particularly significant given current HIV statistics. Most new HIV infections originate from individuals unaware of their status, with over 30,000 new infections occurring annually in the United States. Early detection through accessible testing improves treatment outcomes and substantially reduces transmission risk, making rapid self-testing a powerful tool in HIV prevention efforts.

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 reliable diagnostics. The INSTI® HIV Self Test will be manufactured in bioLytical's state-of-the-art facility, which maintains MDSAP: ISO 13485:2016 Quality Management System standards to ensure product quality and reliability.

The test will soon be available through major retailers and online platforms. Consumers can visit https://www.biolytical.com for updates and purchasing information. This expanded availability supports broader public health goals by reducing undiagnosed HIV cases and creating more opportunities for early detection and treatment connection.

By addressing critical testing gaps, particularly for individuals facing barriers related to stigma, cost, or geographic location, the INSTI® HIV Self Test represents a meaningful step forward in making HIV testing more convenient and accessible. The product's shelf-stable nature and portability make it ideal for on-the-go testing, further expanding its potential impact across diverse communities and settings throughout the United States.