FDA Approves LetsGetChecked's At-home STI Test
The U.S. Food and Drug Administration (FDA) has granted marketing authorisation to LetsGetChecked for the Simple 2 Test, the first-ever diagnostic test for chlamydia and gonorrhoea with at-home sample collection. This allows individuals aged 18 and older to discreetly test for these common sexually transmitted infections (STIs) from the privacy of their homes.
Before this authorisation, tests for chlamydia and gonorrhoea required samples collected at the point of care, such as a doctor's office. The Simple 2 Test is now available over-the-counter (OTC), aiming to empower individuals with more information about their health.
Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, emphasised the importance of this milestone, stating, "This authorisation marks an important public health milestone, giving patients more information about their health from the privacy of their own home. 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."
Chlamydia and gonorrhoea are the first and second most common bacterial STIs in the United States, with steadily increasing rates. The Centers for Disease Control and Prevention's Sexually Transmitted Infections Surveillance Report estimated over 1.6 million cases of chlamydia and more than 700,000 cases of gonorrhoea in 2021 alone. Timely testing is crucial, as these infections, if left untreated, can lead to serious health complications, including infertility.
The Simple 2 Test utilises vaginal swabs or urine specimens for at-home sample collection and can detect the presence of Chlamydia trachomatis and Neisseria gonorrhoeae, the bacteria causing chlamydia and gonorrhoea, respectively. It is a direct-to-consumer test that can be purchased without a prescription. The user activates the collection kit online, fills out a health questionnaire, and collects the specimen at home. The kit is then sent back to the designated laboratory for testing, with results delivered online. Positive or invalid test results prompt follow-up from a healthcare provider.
The FDA reviewed the Simple 2 Test under the De Novo premarket review pathway, establishing special controls related to labelling and performance testing. This regulatory classification allows subsequent devices of the same type to go through the FDA’s 510(k) premarket process, potentially streamlining future approvals for similar tests.
