FDA grants approval for first time to a home test for chlamydia and gonorrhea

The Food and Drug Administration granted marketing approval to a home test for chlamydia and gonorrhea on Wednesday, the first such authorization of a home test to detect the two most common sexually transmitted infections in this country.

The marketing approval was granted to LetsGetChecked’s Simple 2 Test, which allows individuals to collect a sample at home that is then submitted to a laboratory for processing. Prior to this, the only approved tests for these two STIs required samples to be collected at medical facilities such as doctors’ offices.

“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more health care into the home.”

The Simple 2 Test will be available over the counter and is intended for use by people aged 18 and older. The only other STI test that allows for home sample collection is for HIV.

Jodie Dionne, an STI expert at the University of Alabama at Birmingham, welcomed the news, saying experts in the field have been advocating for this approach for some time.

“It is exciting to see the FDA recognize the value of this type of testing by granting marketing authorization through the premarket review pathway,” Dionne, an associate professor of infectious diseases, said in an email.

“There are many people who would like to be tested for STIs who may not know where to go or who have barriers to accessing medical care. If we are going to do a better job of reaching more sexually active people for STI testing as recommended … we need to be creative about how to get them tested and treated in a way that is highly effective and works for them.”

Alan Katz, an STI expert at the University of Hawaii, said the test deploys the same assay clinicians use to diagnose chlamydia and gonorrhea, an assay that has an excellent accuracy record. And Katz, who is a medical consultant at the Hawaii State Department of Health’s Diamond Head STI/HIV Clinic, said this approach also has other advantages.

“This option is exceptionally useful for individuals who live in rural areas or are geographically distanced from a clinic where STI testing can be done and there is no telehealth option available,” he said via email. “If a person screens positive, they can then contact a healthcare provider for further evaluation and treatment.”

Rates of new infections of chlamydia and gonorrhea have been soaring in the U.S. The Centers for Disease Control and Prevention estimates there were more than 1.6 million cases of chlamydia in 2021, and over 710,000 cases of gonorrhea the same year. Both infections are curable, but if left untreated can trigger serious long-term effects, including infertility.

Home samples are taken either using vaginal swabs or urine samples, which are then submitted to a designated laboratory. Results are delivered online, with follow-up care provided when a diagnosis is positive or ambiguous.

Unapproved home tests for chlamydia and gonorrhea have existed for some time, but until now none has gone through the FDA’s approval process. This approval may make it easier for future such tests to clear the FDA’s regulatory pathway.