FDA Approves 1-Minute HIV Self-Test

The FDA approved the first 1-minute HIV self-test (Insti; bioLytical Laboratories Inc), offering a portable and discreet self-testing option to overcome barriers to traditional health care for patients.¹

“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,” Ana Subramanian, vice president of Scientific Affairs at bioLytical, said in a news release. “This milestone ensures that more people across the US can confidently access accurate HIV testing when and where they need it most.”¹

How to Use Insti’s HIV Self-Test

The HIV self-test requires a drop of blood from the fingertip and provides accurate and reliable results in 1 minute. Self-testing is convenient, private, and discreet, allowing patients to test at home and on the go at any time without needing an appointment.¹

“HIV testing should be simple, fast, and accessible for everyone,” Robert Mackie, CEO of bioLytical, said in the news release. “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.”¹

Insti HIV Self-Tests also address gaps in screening for patients that experience barriers to traditional health care testing for HIV, including stigma, cost, or location. Offering a portable and discreet test allows patients to privately self-test on their own terms.¹

Data Supporting Insti Approval

The Insti HIV Self-Test was prequalified by the World Health Organization (WHO) in 2018, and the product is based on the Insti HIV-1/HIV-2 antibody tests that were approved by the FDA, Health Canada, and WHO as the only rapid HIV test. Data from the self-HIV test demonstrated 100% sensitivity and 100% specificity compared with a fourth-generation HIV antigen/antibody enzyme-linked immunosorbent assay (ELISA). Further results from field studies found that 95% of patients believed the self-test was easy to use, they would use it again, and they would recommend it to family members and partners.³

Understanding Testing, Prevention and Treatment for HIV

Nearly 1.2 million Americans live with HIV, and over 30,000 new infections occur annually in the US. Around 13% of individuals living with HIV do not know they have it, emphasizing the need for testing and early detection to improve treatment options and reduce transmission risk.¹

According to the CDC, by 2030, experts wish to reduce HIV infections by 90% as part of the US public health goal of Ending the HIV Epidemic (EHE) using 4 science-based strategies: diagnose, treat, prevent, and respond. This also includes using the latest systems and technology and applying novel approaches to make HIV testing more accessible, such as the Insti HIV Self-Test. Once an individual is diagnosed, the CDC focuses on treatment strategies that support early initiation of antiretroviral therapy and provides training and educational resources to health care providers and patients.²

Insti’s Access and Accessibility

The company noted that the Insti HIV Self-Test will be available at major retailers and online soon, indicated to reduce undiagnosed HIV cases and expand screening options to allow patients to receive HIV care sooner.¹

“By breaking down barriers to testing, we are helping more people take control of their health,” Mackie said in the news release. “This test is a powerful tool in the fight against HIV, providing immediate answers when they matter most.”¹

REFERENCES

1. HIV Self-Testing Just Got Faster: FDA Approves the 1-Minute INSTI® HIV Self Test. bioLytica. News release. October 14, 2025. Accessed October 15, 2025. https://www.biolytical.com/post/fda-approves-the-1-minute-insti-hiv-self-test

2. Ending the HIV Epidemic in the US Goals. CDC. News release. March 20, 2024. Accessed October 15, 2025. https://www.cdc.gov/ehe/php/about/goals.html

3. INSTI HIV Self Test Earns WHO Prequalification Status for Home Testing. bioLytica. News release. November 27, 2018. Accessed October 15, 2025. https://www.biolytical.com/post/fda-approves-the-1-minute-insti-hiv-self-test