FDA Authorizes First At-Home Test for Syphilis as Cases Spike

The U.S. Food and Drug Administration (FDA) has authorized NOWDiagnostic to market the first at-home, over-the-counter test for syphilis. This approval comes amidst a rising trend of syphilis cases in the United States.

Syphilis is a sexually transmitted infection that can lead to serious health problems if left untreated, such as heart and brain damage, blindness, deafness, and paralysis.

The infection can also be passed on during pregnancy, potentially resulting in miscarriage, infant death, and lifelong medical issues. People infected with syphilis may not exhibit any symptoms.

The FDA cautions that the test results alone are not sufficient to diagnose a syphilis infection and should be followed by additional laboratory testing for confirmation.

The main risk associated with the test is the potential for false positive or false negative results, the FDA noted.

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False negative results from the test can lead to treatment delays, disease progression, and further infection spread, the FDA warned. False positive results may delay accurate diagnosis.

Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, highlighted that the test could be beneficial for individuals hesitant to seek healthcare providers for potential sexually transmitted disease exposure.

The World Health Organization (WHO) revealed that global syphilis cases among individuals aged 15 to 49 increased by over a million in 2022, reaching a total of 8 million cases. The Americas and African regions witnessed the highest spikes.

In 2022, there were 230,000 syphilis-related deaths globally, according to the WHO. WHO Director-General Tedros Adhanom Ghebreyesus expressed significant concerns about the rising number of syphilis cases.

These cases led to around 150,000 early fetal deaths and stillbirths in 2022, with 115,000 infants diagnosed with congenital syphilis, the WHO reported.