The FDA has authorized the first over-the-counter at-home antibody test for syphilis, manufactured by NOWDiagnostics, Inc., allowing the company to sell the test.
The test, called First To Know, requires only a drop of blood and provides results in about 15 minutes, offering an early indication that a person may have syphilis.
The big picture: First To Know must be confirmed by a doctor, and the FDA believes it provides a new option for people who may be unable or reluctant to visit a doctor for testing.
- The test will be available for $29.98 and is expected to be sold at major retailers in fall 2024.
Driving the news: In a clinical study, the test correctly identified 99.5% of negative specimens and 93.4% of positive specimens when compared to three FDA-cleared laboratory tests.
- Syphilis, when left untreated, can cause serious health problems, including hearing loss, blindness, nerve damage, damage to internal organs and even death.
By the numbers: The U.S. has seen a significant increase in syphilis cases in recent years, with the CDC reporting a nearly 80 percent increase from over 113,000 cases in 2018 to more than 203,000 in 2022.
Zoom in: The increase also includes a growing number of cases in babies born to untreated mothers, known as congenital syphilis, which can cause a variety of health problems for infants.
What they’re saying: “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 Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, in a statement. “This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection.”
