FDA Authorizes First At-Home Test For Chlamydia, Gonorrhea

By Jessica Karins / November 15, 2023 at 6:36 PM
FDA granted marketing authorization Wednesday (Nov. 15) for a new at-home diagnostic test for chlamydia and gonorrhea, which will be available over the counter, allowing patients to test for the two common sexually transmitted infections (STIs) outside of care provider settings for the first time. The Center for Devices and Radiological Health (CDRH) announced the authorization was granted to company LetsGetChecked for its Simple 2 test. The only previously available tests for chlamydia and gonorrhea required sample collection at a...

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