First At-Home Test for Chlamydia and Gonorrhea Authorized by FDA

The FDA on Wednesday granted marketing authorization to the first chlamydia and gonorrhea test that allows for at-home sample collection.

Intended for adults, the over-the-counter (OTC) Simple 2 test marks the first home diagnostic for sexually transmitted infections (STIs) outside of those for HIV.

“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, said in a statement.

The move comes as cases of chlamydia and gonorrhea, the two most common bacterial STIs, have exploded in recent years. In 2021 alone, the U.S. recorded roughly 1.6 million chlamydia cases and 710,000 gonorrhea cases, according to the CDC.

Left untreated, the STIs can cause serious complications, but in most cases a course of antibiotics will resolve the infections. The agency expects the home test to help patients get quicker access to treatment and help curb the spread.

At-home collection for the Simple 2 test involves either a vaginal swab or urine specimen to detect the bacteria causing the infections, Chlamydia trachomatis and Neisseria gonorrhoeae. After filling out a questionnaire, the specimen is sent back to maker LetsGetChecked’s CLIA- and CAP-certified laboratory, with results delivered online after 2 to 5 days, the company said. Follow-up with a healthcare provider is offered in the cases of a positive or invalid result.

According to FDA, studies performed by the developer showed that individuals understood how to use the testing kits and how to interpret the results.

“Risks associated with the test are mainly the possibility of false positive and false negative test results,” the agency said.

Authorization of the Simple 2 test under the de novo premarket review pathway will open the door to similar tests that prove equivalence under the agency’s 510(k) pathway, the FDA said.

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