At-home STD tests expand screening and treatment options

The FDA has cleared new at-home testing options for common STIs and approved two oral drugs for gonorrhea, broadening screening and treatment choices while raising questions about surveillance and access.

New at-home options for testing and treating common sexually transmitted infections have moved through federal review and are now available or recently approved. The FDA cleared an over-the-counter three-in-one test for gonorrhea, chlamydia and trichomoniasis for women, and also approved a home collection kit for HPV. The agency approved two oral drugs for gonorrhea, the first new treatment options for the disease in decades. These developments come after high STI rates around the time of the COVID-19 pandemic and follow changes in testing technology and federal screening guidance. Key facts: - Visby Medical launched an FDA‑approved three-in-one home test for gonorrhea, chlamydia and trichomoniasis that reports results via an app and includes a telehealth consultation; study data showed diagnostic accuracy around 98%. - Teal Health received FDA clearance for an HPV self-collection kit that users mail to a laboratory for processing, and updated federal screening guidance endorsed self-collection. - The FDA approved two new oral drugs for gonorrhea, Nuzolvenc and Bluejepa, adding treatment options after many years without new approvals. - CDC provisional data for 2024 showed declines in gonorrhea, adult chlamydia and some syphilis measures, while experts note potential challenges for surveillance and access because of higher costs for some at-home tests and recent public health funding cuts. Summary: These approvals broaden available options for people to screen for and, in some cases, receive medication for common sexually transmitted infections. Undetermined at this time.