FDA granted Marketing Authorization of first test for chlamydia and gonorrhea with at-home sample collection

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On Nov. 15, 2023, the U.S. Food and Drug Administration granted marketing authorization to LetsGetChecked for the Simple 2 Test. This is the first diagnostic test for chlamydia and gonorrhea with at-home sample collection to be granted marketing authorization.

Prior to todayメs authorization, the only cleared tests for either condition were used with samples collected at the point of care, such as a doctorメs office. The Simple 2 Test is available over-the-counter (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.

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