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SRC-c7ed3acd03d58a24 · Source record

FDA Grants Marketing Authorization of First Home Test for Chlamydia, Gonorrhea and Trichomoniasis

US Food and Drug Administration · 3 connected claims

D15 · Experience Design, Interfaces & SpatialD24 · Frontier Science & Wildcards

Canonical route

https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-home-test-for-chlamydia-gonorrhea-and-trichomoniasis

Claims connected to this source

  1. MWITA-WH-2026-015In March 2025 the FDA authorized the first over-the-counter test performed entirely at home for chlamydia, gonorrhoea and trichomoniasis, with results in about 30 minutes.Evidence A
  2. MWITA-WH-2026-016FDA-reported study performance for the authorized home test included 97.2% positive and 98.8% negative agreement for chlamydia.Evidence A
  3. MWITA-WH-2026-017FDA-reported study performance for the same test included 100% positive and 99.1% negative agreement for gonorrhoea, and 97.8% positive and 98.5% negative agreement for trichomoniasis.Evidence A

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