FDA clears its first mail-in STI test for chlamydia, gonorrhea with LetsGetChecked kit

The FDA has cleared its first at-home test for chlamydia and gonorrhea, the two most common sexually transmitted diseases in the U.S., amid steadily rising numbers of cases. 

Sold by LetsGetChecked—a former Fierce 15 winner that made a name for itself in remote testing during the COVID-19 pandemic—the over-the-counter Simple 2 test allows adults to collect a vaginal swab or urine sample within the privacy of their own home and then mail it to a lab for a result. 

The FDA described the de novo clearance as a public health milestone, with it being the first agency-authorized home test for any sexually transmitted disease other than HIV. Previously, the only cleared tests for either condition relied on samples collected at a doctor’s office or clinic.

The Simple 2 test can be mailed directly to the user and includes a prepaid shipping label to return the sample. It includes collection kits developed by Hologic for its Aptima combination chlamydia and gonorrhea bacteria assay. 

LetsGetChecked said it expects to turn around online results within two to five days and will offer virtual consultations for follow-up treatments if necessary, as part of an end-to-end telehealth system.

According to data from the Centers for Disease Control and Prevention, the U.S. logged about 1.6 million cases of chlamydia and more than 700,000 cases of gonorrhea in 2021, placing the two infections well within epidemic territory. 

The conditions can typically be treated easily, according to the FDA, but if they go untreated, both can cause serious health complications, such as infertility.