FDA Greenlights 1st Home Test for 2 Sexually Transmitted Diseases

Published on November 16, 2023

The U.S. Food and Drug Administration (FDA) has granted marketing authorization for at-home tests for two sexually transmitted diseases (STDs), the agency announced on Nov. 15. FDA officials greenlit the “LetsGetChecked Simple 2 Test,” after data showed users could safely use the kit and have a “general understanding” of the results and take any follow-up actions when necessary. The test allows patients to check for the presence of gonorrhea and chlamydia—two of the most common bacterial STDs—in the comfort of their own homes as opposed to at a doctor’s office. After HIV, this is the first FDA-authorized diagnostic test that will allow at-home sample collection for a sexually transmitted infection, according to the federal agency....