FDA Approves First 1-Minute Self Test for HIV

The FDA approved Insti HIV Self Test, which is the first 1-minute HIV self-test available in the United States. The self test requires a drop of blood from a person’s fingertip to provide results in 60 seconds.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.¹ “This milestone ensures that more people across the US can confidently access accurate HIV testing when and where they need it most.”

Approximately 1.2 million people in the US have HIV, with approximately 13% unaware they have it and need testing. In 2022, approximately 31,800 people acquired HIV in the US, according to the CDC. However, annual infections in the US have been reduced by more than two-thirds since the height of the epidemic in the mid-1980s. It is estimated that the increases in pre-exposure prophylaxis prescriptions, viral suppression, and HIV testing are likely to contribute to the decline.²

Since the 1980s, HIV incidence has decreased, with the highest number of infections (130,400) in 1984 and 1985 decreasing to 34,800 in 2019. Of note, the CDC noted that a larger proportion of infections was reported among Black/African American and Hispanic/Latino patients in 2019 than in 1981. The majority of infections are among men who have sex with men, at 63% in 1981 and 66% in 2019, according to the CDC. There is currently no cure or vaccine for HIV; however, prevention tools, which can include HIV testing, have led to substantial decreases in new HIV infections. Implementing more strategies could help to decrease HIV transmission, morbidity, and mortality.³

The CDC also noted that a major factor in the reduction of infection has been the participation of patients who have HIV, community activists, politicians, researchers, and public health officials in raising awareness of the epidemic. Further, public health and health care experts can help to address stigma and discrimination in the HIV space, which can help to close the gaps in access and other social and economic determinants.³

The test is a single-use, rapid, in vitro diagnostic immunoassay for the detection of HIV antibodies and is intended for users 18 years and older. According to the approval letter, the device should be stored at 2°C to 30°C in the original packaging in cool and dry locations. According to the news release, the test is reliable and convenient as well as ideal for on-the-go testing. It is expected to be available soon at major retailers and online as an OTC product.^1,4

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

READ MORE: FDA Updates Resource Center

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REFERENCES

1. HIV self-testing just got faster: FDA approves the 1-minute Insti HIV self test. News release. bioLytica. October 14, 2025. Accessed October 16, 2025. https://www.biolytical.com/post/fda-approves-the-1-minute-insti-hiv-self-test

2. HIV.gov. US Statistics. Updated September 18, 2025. Accessed October 16, 2025. https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics

3. Bosh KA, Hall HI, Eastham L, Daskalakis DC, Mermin JH. Estimated Annual Number of HIV Infections ─ United States, 1981–2019. MMWR Morb Mortal Wkly Rep 2021;70:801–806. doi:http://dx.doi.org/10.15585/mmwr.mm7022a1

4. US Food and Drug Administration. INSTI HIV Self Test approval letter, October 9, 2025. Accessed October 16, 2025. http://janeganter.com/crastudentwriters/cite_fda_approval_ltr.pdf