The FDA approval marks an important public health milestone in the ongoing effort to empower patients to take control of their own health.
The FDA granted marketing authorization to LetsGetChecked for the Simple 2 Test, making it the first FDA-authorized diagnostic test for chlamydia and gonorrhea with at-home sample collection, as well as the first for any sexually transmitted disease other than HIV.1
The Simple 2 Test was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Before the collection kit’s approval, the only authorized tests for either chlamydia or gonorrhea were those used with samples collected at the point of care.
After purchasing the Simple 2 Test collection kit, available over the counter for intended use by adult patients ages 18 and older, the user activates it online and fills out a health questionnaire for evaluation by a health care provider. Samples are then collected at-home via provided vaginal swabs or urine specimens, as appropriate, and sent back to the designated laboratory for testing. Once samples are tested for the presence of the bacteria Chlamydia trachomatis, which causes chlamydia, and Neisseria gonorrhoeae, which causes gonorrhea, results are delivered online to the user. In cases of positive or invalid test results, follow-up from a health care provider is scheduled.
Data evaluated by the FDA from LetsGetChecked, the parent company of Simple 2 Test, demonstrated that users could safely use the kit and form a general understanding of their results and any follow up protocol. The Simple 2 Home Collection Kits, included in the Simple 2 Test, were validated for use with the approved Hologic Aptima 2 Combo Assay.
The FDA-approved Simple 2 Test will act as a valuable combatant against steadily increasing rates of chlamydia and gonorrhea, which rank respectively as the first and second most common sexually transmitted infections (STI) in the United States. In 2021 alone, there were an estimated 1.6 million cases of chlamydia and more than 700,000 cases of gonorrhea.
Left untreated, chlamydia and gonorrhea can lead to serious health complications for patients, including infertility. The approval of the Simple 2 Test and the resulting expansion of treatment options for these STIs will facilitate quicker results and access to the best possible treatment, potentially resulting in better health outcomes for patients.
The approval of the Simple 2 Test has brought with it the establishment of a new regulatory classification by the FDA that will allow devices of the same type with the same intended use to go through the FDA’s 510(k) premarket process. In this time- and expense–saving process, devices can be granted marketing authorization by demonstrating substantial equivalence to a predicate device.
The Simple 2 Test collection kit, although cleared by the FDA, poses risks to users, namely those associated with the possibility of false positive and false negative test results. If given a false negative test result, users could experience delays to effective treatment, progression to disseminated disease, and spread of infection to others. If given a false positive result, users could experience unnecessary diagnoses and unnecessary treatment for the STIs, leading to psychological distress, delays in receiving correct diagnoses, and various expenses and side effects associated with said treatment.
Still, the FDA approval of Simple 2 Test represents a significant step forward in integrating health care into the home setting and empowering patients to take control of their own health.
“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, MD, JD, 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.”