Curated News
By: NewsRamp Editorial Staff
October 14, 2025
FDA Approves First One-Minute HIV Self-Test in U.S.
TLDR
- BioLytical's FDA-approved INSTI HIV Self Test provides a competitive advantage by delivering highly accurate results in 60 seconds, enabling immediate health decisions.
- The INSTI HIV Self Test works by analyzing a single drop of blood from a fingertip and provides reliable results within one minute through rapid diagnostic technology.
- This test makes the world better by expanding HIV testing access, reducing transmission risks, and supporting the goal to decrease HIV infections by 90% by 2030.
- BioLytical's INSTI HIV Self Test offers the fastest home HIV testing available, providing private results in just 60 seconds using portable, discreet technology.
Impact - Why it Matters
This development represents a transformative moment in HIV prevention and public health accessibility. The availability of a rapid, accurate, and private self-testing option addresses significant barriers that have historically prevented people from getting tested, including stigma, cost concerns, and limited access to healthcare facilities. For individuals, this means immediate knowledge of their HIV status without the anxiety of waiting days or weeks for results, enabling faster access to treatment if needed and reducing transmission risks. At a population level, increased testing accessibility directly supports national public health goals to end the HIV epidemic by identifying undiagnosed cases and connecting people to care sooner. The convenience and privacy of this testing method could significantly increase testing rates among high-risk populations and those who might otherwise avoid traditional testing settings, ultimately contributing to reduced infection rates and improved public health outcomes across communities.
Summary
The U.S. Food and Drug Administration has granted approval to bioLytical Laboratories Inc.'s INSTI® HIV Self Test, marking a revolutionary advancement in HIV testing accessibility. This groundbreaking development makes the INSTI® test the first one-minute HIV self-test available to American consumers, providing highly accurate results in just 60 seconds using a single drop of blood from a fingertip. The test's approval represents a significant milestone in public health innovation, offering a private, discreet, and portable testing solution that eliminates barriers to traditional healthcare access. As CEO Robert Mackie emphasized, this technology empowers individuals to take control of their health without waiting for clinic appointments or laboratory results, fundamentally transforming how people can monitor their HIV status.
The timing of this FDA approval is particularly crucial given the ongoing HIV epidemic in the United States, where approximately 1.2 million Americans are living with HIV and an estimated 13% remain unaware of their status. With over 30,000 new infections occurring annually and most transmissions coming from undiagnosed individuals, the INSTI® HIV Self Test addresses critical gaps in screening accessibility. The test's ultra-fast results, high accuracy, and convenience make it an essential tool in achieving the national public health goal of Ending the HIV Epidemic by reducing infections by 90% by 2030. As Vice President of Scientific Affairs Ana Subramanian noted, this approval reflects both the scientific integrity of bioLytical's work and their commitment to expanding access to reliable diagnostics through their website and other platforms.
The INSTI® HIV Self Test will soon be available through major retailers and online channels, with updates and purchasing details accessible through bioLytical's website. The company's manufacturing occurs in state-of-the-art facilities maintaining MDSAP: ISO 13485:2016 Quality Management System standards, ensuring the highest quality for this critical healthcare tool. As a global leader in rapid infectious disease diagnostics, bioLytical continues to leverage its proprietary INSTI® technology platform to create meaningful outcomes for medical professionals, patients, and public health organizations worldwide. This innovation supports broader public health objectives by reducing undiagnosed HIV cases, expanding screening opportunities, and helping connect people to care sooner through their comprehensive diagnostic solutions available through their website and other digital platforms.
Source Statement
This curated news summary relied on content disributed by Noticias Newswire. Read the original source here, FDA Approves First One-Minute HIV Self-Test in U.S.
