FDA Grants First Authorization for Over-the-Counter Syphilis Test

Original from: 360dx

The US Food and Drug Administration announced on Friday that it has granted de novo marketing authorization to an over-the-counter test for syphilis antibodies manufactured by NowDiagnostics.

The test is the first at-home OTC syphilis test to be authorized by FDA, the agency said in a statement. 

The NowDiagnostics First To Know Syphilis Test detects antibodies against Treponema pallidum, the pathogen that causes syphilis, in blood samples. A positive antibody test is not sufficient to diagnose a current syphilis infection, however. The FDA noted that the 15-minute test can inform patients of current or past infection and ultimately lead to confirmatory testing with a healthcare provider.

"Testing is one of the most important tools we have in preventing the spread of sexually transmitted infections," said Rob Weigle, CEO of NowDx in a separate statement. "For the first time ever, consumers now have a fast and simple syphilis test that can be performed in the privacy of one's home, with a result in minutes," he added.

After being nearly eradicated in the 1990's, the number of syphilis cases in the US jumped 80 percent between 2018 and 2022, according to the US Centers for Disease Control and Prevention. Cases of syphilis acquired by babies from their mothers during pregnancy and childbirth, meanwhile, increased tenfold since 2012, with more than 3,700 cases of congenital syphilis in 2022. 

The US Department of Health and Human Services established the National Syphilis and Congenital Syphilis Syndemic Federal Task Force this year and published guidance for point-of-care syphilis testing in June. 

The authorization of the NowDiagnostics 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 US, the FDA said.

Last year, the FDA authorized the first diagnostic test for chlamydia and gonorrhea that uses at-home sample collection, which the agency noted was the first FDA-authorized test with at-home sample collection for any sexually transmitted infection other than HIV. That test is manufactured by LetsGetChecked.

"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, acting director of the FDA’s Center for Devices and Radiological Health. 

Tarver also commented that access to home tests may help increase initial screening for syphilis, which in turn may lead to increased lab testing to confirm diagnosis, increased treatment, andreduction in the spread of infection.

The FDA also noted that subsequent syphilis testing devices for the same intended use can now go through the 510(k) premarket authorization process. 

As previously reported, there are currently two FDA-cleared, CLIA-waived 15-minute syphilis immunoassays for professional use. Syphilis Health Check from Diagnostics Direct — which is semi-exclusively distributed by OraSure — detects both IgG and IgM antibodies to the bacteria. The DPP HIV-Syphilis is a combination HIV and syphilis rapid test from Chembio Diagnostics, a firm that was acquired last year for $17.2 million by French rapid test maker Biosynex. 

MedMira, meanwhile, obtained the CE mark for its Multiplo Complete Syphilis (TP/nTP) Antibody Test in 2022, while QuidelOrtho also plans to add a syphilis target to its Savanna herpes panel, and a diagnostic technology from SD Biosensor was recently licensed by the World Health Organization and the Medicines Patent Pool and it is available for sublicensing to develop rapid tests. 

NowDx raised $22 million in July to bring the test to market, and First To Know Syphilis Tests are expected to be available at major national retailers and online by the end of the year.

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Source: FDA Grants First Authorization for Over-the-Counter Syphilis Test