The U.S. Food and Drug Administration (FDA) has granted marketing authorization for at-home tests for two sexually transmitted diseases (STDs), the agency announced on Nov. 15.
FDA officials greenlit the “LetsGetChecked Simple 2 Test,” after data showed users could safely use the kit and have a “general understanding” of the results and take any follow-up actions when necessary.
The test allows patients to check for the presence of gonorrhea and chlamydia—two of the most common bacterial STDs—in the comfort of their own homes as opposed to at a doctor’s office.
After HIV, this is the first FDA-authorized diagnostic test that will allow at-home sample collection for a sexually transmitted infection, according to the federal agency.
“Prior to today’s authorization, the only cleared tests for either condition were used with samples collected at the point of care, such as a doctor’s office,” the FDA said.
According to its website, the Simple 2 Test, made by New York- and Dublin-based LetsGetChecked, costs $99.
Users of the kit must activate online and fill out a health questionnaire for a health care provider to evaluate. They then collect a vaginal swab or a urine sample with the test kit, which they then send back to the company’s laboratory to be tested for the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause chlamydia and gonorrhea, respectively.
‘Important Public Health Milestone’
The test kit can be purchased without a prescription for individuals ages 18 years and older.
Results are delivered online and users must follow up with a health care provider in cases of positive or invalid test results.
The FDA noted, however, the risk that the kits could potentially produce false positive and false negative test results which could either lead to delays in effective treatment or psychological distress.
Still, the agency is establishing “special controls” that define the requirements related to labeling and performance testing, and when met, those controls, in combination with others, provide a “reasonable assurance of safety and effectiveness for tests of this type.”
“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” said Dr. 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.”
Chlamydia, Gonorrhea Cases Rising
Chlamydia and gonorrhea are the first and second most common bacterial STDs, also known as sexually transmitted infections, in the United States, and are transmitted through sexual contact with the penis, vagina, mouth, or anus of an infected partner without a condom, according to the Centers for Disease Control and Prevention (CDC).
Ejaculation does not have to occur for either of the diseases to be transmitted or acquired and the STDs can also be spread perinatally from mother to baby during childbirth.
Chlamydia, if left untreated, can also cause permanent damage to a woman’s reproductive system, making it harder, or in some cases impossible, to get pregnant in the future. It can also cause a potentially fatal ectopic pregnancy, or a pregnancy that occurs outside the womb, according to the CDC.
Chlamydia and gonorrhea often have no symptoms, although infected individuals can sometimes experience pain or a burning sensation when urinating, bleeding between menstrual periods, and painful or swollen testicles.
Both STDs can be treated with antibiotics.
There were 1,644,416 reports of chlamydia cases in 2021 and 710,151 cases of gonorrhea reported to the health agency in that same year, according to the CDC’s Sexually Transmitted Infections Surveillance Report, and cases have been steadily on the rise.
However, the agency noted that the COVID-19 pandemic had led to significant disruptions in STD-related prevention and care activities, including a reduction in screening for the diseases, which likely led to under-reporting of infections and possibly increased STD transmission.