The approval marks the first authorized at-home sample collection test for sexually transmitted diseases.
The FDA has approved LetsGetsChecked De Novo’s classification request for the Simple 2 at-home collection system that tests for chlamydia and gonorrhea. This kit marks the first FDA-authorized home sample collection system for sexually transmitted infections (STIs) other than HIV.
“We are honored to receive this landmark De Novo classification and authorization from FDA for our chlamydia and gonorrhea testing system, which demonstrates the value of our robust end-to-end at-home care system,” said Peter Foley, Founder and CEO of LetsGetChecked, in a press release. “Our vertically integrated platform, coupled with the authorization of our testing solution will empower individuals to proactively manage their health from home. We greatly appreciate FDA’s collaboration throughout this process.”
According to the CDC, 1.6 million cases of chlamydia were estimated in 2021 and more than 700,000 cases of gonorrhea were also reported. The CDC has deemed STIs an epidemic, including chlamydia and gonorrhea.
The Simple 2 at-home collection system tests for gonorrhea and chlamydia in individuals 18 years and older through a vaginal swab or a urine sample. Following the test, the system includes an at-home sample collection kit that could be delivered to where the individual resides with a prepaid label to return the sample. The sample is then analyzed in LetsGetChecked’s high complexity laboratory that is CLIA and CAP-certified in the United States.
The press release noted that the samples are retrieved using collection devices from Hologic. Individuals could expect the results online 2 to 5 days after testing with included treatment and consolations, based on the results.
The approval of the tool will provide a new regulatory classification and standard for at-home self-testing for STIs.
“We are proud to support LetsGetChecked on this first-ever FDA-authorized at-home collection kit for chlamydia and gonorrhea, which uses our best-in-class technology,” said Jennifer Schneiders, Ph.D, Hologic Diagnostics Solutions President, in a press release. “Our priority as an organization is to ensure people have access to the highest standards of care to safeguard their health. As STIs continue to rise at alarming rates, we are committed to innovative testing strategies that bring additional testing options to people everywhere.”
LetsGetChecked Receives U.S. Food and Drug Administration (FDA) De Novo Authorization for At-Home Chlamydia and Gonorrhea Testing System. Business Wire. News release.