FDA Greenlights At-Home Syphilis Test

FDA has cleared what it said is the first at-home, over-the-counter test to help with the detection of syphilis. The test was developed by NOWDiagnostistics and detects reponema pallidum (syphilis) antibodies in human blood.

FDA said the results from this type of test alone are not sufficient to diagnose syphilis infection and should be followed by additional testing to confirm a diagnosis of syphilis.  

Before the clearance, there was no over-the-counter test to inform a user about a potential syphilis infection. The test provides an at-home result without a prescription, in approximately 15 minutes, which individuals can use to better inform next steps with a health care provider.

“We continue to see advancements in tests, particularly tests for sexually transmitted infections, which can give patients more information about their health from the privacy of their own home,” said Michelle Tarver, MD, PhD, acting director of FDA’s Center for Devices and Radiological Health. “Access to home tests may help increase initial screening for syphilis, including in individuals who may be reluctant to see their health care provider about possible sexually transmitted infection exposure. This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection.”

Related:FDA Allows for First Point-of-Care Chlamydia and Gonorrhea Test

In response to the surging number of syphilis and congenital syphilis cases nationwide, earlier this year, the Department of Health and Human Services established the National Syphilis and Congenital Syphilis Syndemic (NSCSS) Federal Task Force to utilize its agencies, expertise, and stakeholder network to respond to the U.S. syphilis and congenital syphilis epidemic.

The authorization of this test will directly contribute toward the goals of the department’s STI National Strategic Plan, which aims to reverse the recent dramatic rise of STIs in the United States.

This announcement follows last year’s authorization of the first diagnostic test for chlamydia and gonorrhea with at-home sample collection, which was the first FDA-authorized test with at-home sample collection for any sexually transmitted infection other than HIV.