In a groundbreaking development, the US Food and Drug Administration has granted authorization for the first at-home over-the-counter test for syphilis. Previously, individuals suspected of having the sexually transmitted infection had to visit a healthcare provider for testing. With the introduction of the new test by biotech company NOWDiagnostics, users can now determine whether they have syphilis in just 15 minutes with a single drop of blood.
However, the FDA emphasizes that this test is just the initial step if someone tests positive for the disease at home. It is recommended that they follow up with a healthcare provider for further testing to confirm the diagnosis. The test is expected to be available in the second half of 2024 and will cost $29.98.
Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, expressed optimism about the advancements in at-home tests for sexually transmitted infections. She highlighted the potential of home tests to increase screening for syphilis and lead to increased treatment and a reduction in the spread of the infection.
Syphilis, which was close to elimination in the 1990s, has seen a significant resurgence in the United States in recent decades. According to the latest data from the US Centers for Disease Control and Prevention, cases of syphilis increased by 80% between 2018 and 2022, with a particularly alarming rise among newborns. In 2022, over 207,000 total syphilis cases were reported, marking the highest number since the 1950s.
Syphilis is a bacterial infection that can have serious consequences if left untreated, including blindness, deafness, and heart damage. The new at-home test for syphilis received FDA authorization based on data from clinical trials, demonstrating its efficacy in identifying positive specimens 93.4% of the time.
NOWDiagnostics hopes that their test will have a significant impact on public health and improve access to timely detection and treatment, especially in underserved populations.