FDA Approves First At-Home Test for Chlamydia, Gonorrhea

17 Nov 2023 • The U.S. FDA has authorized LetsGetChecked to market the Simple 2 Test, marking the first approval for a diagnostic test for chlamydia and gonorrhea that allows for at-home sample collection. The Simple 2 Test is available OTC and is intended for use in adult patients ages 18 years and older. It is the first FDA-authorized test with at-home sample collection for any sexually-transmitted disease other than HIV.

The Simple 2 Test which uses vaginal swabs or urine specimens, as appropriate, can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause chlamydia and gonorrhea, respectively.

Source: FDA | Read full story

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