Amidst an increase in numbers, the FDA authorizes the first at-home, non-prescription syphilis test.
Until now, individuals suspecting they might have a sexually transmitted infection had to pay a visit to the doctor for a test. But with the new 15-minute, single-drop-of-blood test from biotech company NOWDiagnostics, individuals can self-diagnose syphilis at home. However, if an individual tests positive at home, the Food and Drug Administration advises them to consult a healthcare professional for a follow-up test to confirm the diagnosis.
The company plans to make this test available in the second half of 2024, with a cost of $29.98.
As Dr. Michelle Tarver, acting director of the FDA's Center for Devices and Radiological Health, mentioned in a press release, "We're witnessing progressive advancements in tests, especially for sexually transmitted infections. These tests can provide patients with valuable health information in their own homes. Home testing might boost initial syphilis screenings, even among those hesitant to consult their healthcare provider about potential sexually transmitted infection exposure. This could lead to increased lab testing, confirmation of diagnosis, and subsequent treatments, ultimately reducing the spread of the infection."
Syphilis had nearly been eradicated in the 1990s, but in recent decades, the number of confirmed cases in the US has risen exponentially. According to the Centers for Disease Control and Prevention, cases increased by 80% between 2018 and 2022, and cases among newborns were more than 10 times higher in 2022 than a decade prior. In 2022, over 207,000 total syphilis cases were reported, marking the highest number since the 1950s.
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Syphilis is a bacterial infection that may initially present with seemingly minor symptoms, such as a sore in the genital or anal area. In its early stages, the sore may heal on its own, but antibiotic treatment is important to prevent the infection from progressing. If left untreated, syphilis can lead to severe health issues, including blindness, deafness, brain and heart damage in adults, and miscarriage or lifelong medical complications for unborn or newly born children.
The First To Know Syphilis Test received FDA approval after clinical trials demonstrated it correctly identified a positive specimen 93.4% of the time. Additionally, the trials indicated that the test was user-friendly for individuals without medical training.
NOWDiagnostics hopes this test will have a substantial impact on public health, improving access to timely detection and treatment, especially among communities with high syphilis prevalence.
This home test for syphilis, as Dr. Tarver mentioned, can provide individuals with important health information, potentially boosting initial screenings and reducing the infection's spread. Regular testing and prompt treatment are crucial to avoid severe health consequences, such as blindness, deafness, brain and heart damage in adults, or lifelong complications in newborns.
