Over-the-counter syphilis test kits could soon be available across the US after the Food and Drug Administration (FDA) handed market authorization for NowDiognostics’ first-at-home syphilis blood test kit, allowing the company to sell it to consumers without needing a prescription.
The test was approved through the FDA’s de novo pathway, with similar products expected to follow the agency’s 510(k) pathway, which provides a less rigorous approval process.
Known as the “First To Know Syphilis Test,” the antibody test can detect syphilis infection from a single blood drop and give results within 15 minutes. However, the FDA noted in their approval announcement that users should undergo additional tests to confirm their results.
Surging Syphilis Cases in the United States
The authorization of the first-in-home over-the-counter syphilis test comes as the number of syphilis infections in the US is soaring. The cases climbed from 115,000 to 207,000 in 2022, translating to an 80% increase, according to the Centers for Disease Control and Prevention (CDC).
The US FDA’s division focusing on devices, the Center for Devices and Radiological Health, noted that the approval of the no-prescription syphilis test could boost the detection and treatment rate of the sexually transmitted illness.
The device will also be suitable for people who feel reluctant to talk to healthcare providers about their potential exposure to a sexually transmitted disease.
First To Know Syphilis Test is the latest at-home test authorized by the FDA. In November, the agency approved LetsGetChecked, an at-home test sample collection for gonorrhea and chlamydia, allowing people to collect samples at home and send them to doctors for testing, and the results sent to sample owners online.
So far, the FDA has approved at-home sample collection only for HIV and gonorrhea.