A syphilis test typically requires a blood sample sent to a lab, and the wait time for results is hours to days. The FDA has approved a new at-home syphilis test, a product from NOWDiagnostics, that provides results in 15 minutes.
The FDA announced Friday that NOWDiagnostics’ test, with its approval, will become the first over-the-counter, at-home syphilis test. Springdale, Arkansas-based NOWDiagnostics, or NOWDx, will market its new syphilis test under the name First-to-Know.
Syphilis is caused by a bacteria, Treponema pallidum. It is treatable with antibiotics such as penicillin. If left untreated, syphilis infection can damage the heart and brain. This infection can also cause blindness, deafness, and paralysis. Reports of this sexually transmitted infection are on the rise. According to the Centers for Disease Control and Prevention, cases increased 80% from 2018 to 2022, continuing a decades-long upward trend.
First to Know tests a single drop of blood to detect antibodies to Treponema pallidum. The FDA’s decision to use this test is based on a clinical trial of 1,270 participants that compared First to Know’s results to those of three FDA-approved laboratory tests. The data shows that negative agreement was 99.5%, meaning the test correctly identified 99.5% of negative samples. Positive agreement, meaning it correctly identified positive samples, was 93.4%.
The FDA cautions that the risks of First to Know are primarily the possibility of false positive or false negative results, the same risks that exist with other diagnostic tests. The agency cautions that positive results from this test alone do not constitute a diagnosis of syphilis infection and that such results should be followed by additional testing to confirm the diagnosis of syphilis.
“There is an urgent need to raise public awareness of the seriousness of untreated syphilis, especially among underserved and marginalized populations,” said Dr. Gregory Bledsoe, former Surgeon General of Arkansas, in announcing NOWDx’s regulatory decision. “A home test like this has the potential to significantly improve public health by increasing access to timely diagnosis and treatment.”
NOWDx is developing over-the-counter and point-of-care diagnostic tests. The company says its technology allows virtually any immunological test to be performed in a single step using a small amount of blood. The company is also developing tests that can analyze saliva samples. In addition to First to Know, the company sells blood tests for pregnancy and Covid-19. It says its pipeline includes more than 30 tests in development.
The FDA said it reviewed First to Know under the de novo premarket review process for new low- to moderate-risk devices. The marketing authorization of First to Know creates a new regulatory classification that establishes this test as a predicate device. Future tests of the same type and intended use can be compared to First to Know, which is being reviewed under the FDA’s 510(k) process.
NowDx’s First to Know does not require a prescription, and the company expects this new syphilis test to be available in retail stores and online later this year. Last month, the company closed a new $22.5 million round of funding to fund the commercialization of First to Know. The Series B round was led by DigitalDx Ventures and included participation from Labcorp Venture Fund and Kompass Kapital Management.
Image: Christoph Burgstedt/Science Photo Library, via Getty Images
