On Friday, the FDA granted NOWDiagnostics marketing approval for the first over-the-counter, home-use syphilis screening test.
The approval follows the approval of the first home test for chlamydia and gonorrhea last year, which was also the first FDA-approved home test for a sexually transmitted infection other than HIV.
“We continue to see advances in testing, particularly testing for sexually transmitted infections, that can give patients more information about their health in the privacy of their own home,” said Michelle Tarver, MD, PhD, deputy director of the FDA’s Center for Devices and Radiological Health, in a press release.
The First To Know Syphilis Test detects Treponema pallidum Antibodies in blood samples taken by finger prick. The test is available over the counter and takes about 15 minutes. If the test is positive, further tests must be done to confirm the diagnosis. Home test results are positive for people who have been previously diagnosed and/or treated for syphilis.
“Access to home testing can help increase initial screening for syphilis, including among people who are reluctant to see their doctor about possible sexually transmitted disease exposure,” Tarver said. “This can lead to increased laboratory testing to confirm the diagnosis, which in turn can lead to increased treatment and a reduction in the spread of infection.”
According to the company, First To Know was evaluated in a clinical trial of 1,270 people using three FDA-approved laboratory tests. The new test showed a negative agreement of 99.5% and a positive agreement of 93.4%.
The United States is currently in the midst of a syphilis epidemic. According to the CDC, syphilis cases increased by nearly 80% from 2018 to 2022, and congenital cases increased by a staggering 183% during the same period.
If left untreated, syphilis can cause serious damage to the heart and brain, leading to blindness, deafness and paralysis. If the disease is transmitted during pregnancy, it can cause miscarriages, lifelong health problems and death of the child.
The FDA reviewed the test as part of the agency’s de novo premarket review process, an approval process for new and unique devices that pose low to moderate risk.
