FDA authorizes first at-home syphilis test

The Food and Drug Administration on Friday granted marketing authorization to the first at-home, over-the-counter test to detect syphilis antibodies in human blood in a move that could help boost screening rates for the sexually transmitted disease.

Developed by privately held NOWDiagnostics, the antibody test helps identify current or past infection and provides a result in about 15 minutes.

However, the regulator added that the results from the test alone are not sufficient for definitive diagnosis, and should be followed by additional testing to confirm a diagnosis.

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“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,” said Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health.

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The number of reported cases of syphilis in the United States increased by 80% between 2018 and 2022, according to the Centers for Disease Control and Prevention.

Syphilis, which was treated with mercury, arsenic, and bismuth before the discovery of penicillin, can cause severe damage to the heart and brain and can cause blindness, deafness and paralysis.