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

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

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

This newly-approved test is designed to detect syphilis antibodies in human blood and will provide results within 15 minutes, according to the regulator.

Syphilis is a sexually transmitted infection that can cause serious health problems if left untreated, including damage to the heart and brain, causing blindness, deafness, and paralysis.

The infection can also be transmitted during pregnancy, potentially leading to miscarriage, infant death, and lifelong medical issues. People infected with syphilis often do not notice any symptoms.

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

The FDA stated that the test’s main risk is the possibility of a false positive or a false negative result.

False negative results can lead to delays in treatment, progression to disseminated disease, and the spread of infection to others, the agency said. False positive results can lead to delays in getting a correct diagnosis.

Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, said the test could benefit those who are reluctant to see health care providers about possible exposure to a sexually transmitted disease.

“This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection,” Tarver said in a statement.

NOWDiagnostic CEO Rob Weigle welcomed the FDA approval, describing the antibody test as “one of the most important tools” in preventing the spread of sexually transmitted infections.

According to the Centers for Disease Control and Prevention (CDC), reported syphilis cases in the United States increased by 80 percent in 2022, from 115,000 cases in 2018 to more than 207,000 in 2022.

The World Health Organization (WHO) stated that global syphilis cases among people aged 15 to 49 rose by more than a million in 2022, totaling 8 million cases. The highest surges were seen in the Americas and the African region.

There were 230,000 syphilis-related deaths in 2022, according to the agency. WHO Director-General Tedros Adhanom Ghebreyesus said the surging number of syphilis cases raises “major concerns.”

“Fortunately, there has been important progress on a number of other fronts including in accelerating access to critical health commodities including diagnostics and treatment,” he said in a May 21 statement.

There were an estimated 700,000 congenital syphilis—where untreated syphilis is transmitted from mother to baby during pregnancy—globally in 2022, according to the WHO.

These cases led to an estimated 150,000 early fetal deaths and stillbirths in 2022, and 115,000 infants with clinical diagnosis of congenital syphilis, the agency stated.