FDA OKs First Syphilis Screening Test for At-Home Use

— Amid a surge in cases, FDA hopes at-home tests will help increase syphilis diagnosis, treatment

by Katherine Kahn, Staff Writer, �鶹��ý August 16, 2024

FDA MARKETING OTC syphilis screening test (First To Know Syphilis Test) over a photo of the product.

The FDA on Friday to NOWDiagnostics for the first at-home, over-the-counter syphilis screening test.

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

"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 the FDA's Center for Devices and Radiological Health, in a press release.

The First To Know Syphilis Test detects Treponema pallidum antibodies in blood samples collected via finger prick. It will be available without a prescription and takes about 15 minutes to perform. If the test is positive, additional testing must be done to confirm a diagnosis. Results of the at-home test will be positive for individuals previously diagnosed and/or treated for syphilis.

"Access to home tests may help increase initial screening for syphilis, including in individuals who may be reluctant to see their healthcare provider about possible sexually transmitted infection exposure," Tarver emphasized. "This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection."

, First To Know was evaluated against three FDA cleared laboratory tests in a clinical study of 1,270 individuals. The new test showed a negative percent agreement of 99.5% and a positive percent agreement of 93.4%.

The U.S. is currently in the midst of a syphilis epidemic. According to the CDC, surged nearly 80% from 2018 through 2022 and congenital cases rose a staggering 183% over the same period.

If left untreated, syphilis can seriously damage the heart and brain and can cause blindness, deafness, and paralysis. When transmitted during pregnancy, it can cause miscarriage, lifelong medical issues, and infant death.

The FDA reviewed the test under the agency's , a regulatory pathway for new and unique low- to moderate-risk devices.

Katherine Kahn is a staff writer at �鶹��ý, covering the infectious diseases beat. She has been a medical writer for over 15 years.