In a significant stride towards proactive healthcare, the U.S. Food and Drug Administration has given the green light to NOWDiagnostics for their First To Know Syphilis Test. This groundbreaking decision marks the arrival of the first ever over-the-counter, at-home test designed to detect Treponema pallidum (syphilis) antibodies in human blood. While it’s crucial to understand that this initial test necessitates further clinical evaluation for a definitive diagnosis, its availability heralds a new era of accessible and early health monitoring.
The timing of this authorization is particularly pertinent as the Centers for Disease Control and Prevention (CDC) reports an alarming 80% surge in syphilis cases across the United States between 2018 and 2022. This upward trajectory, reaching over 207,000 reported cases in 2022, underscores the urgent need for enhanced and readily available diagnostic tools.
Prior to this pivotal approval, individuals seeking to ascertain a potential syphilis infection were limited to clinical settings. The First To Know Syphilis Test revolutionizes this landscape by offering a private, at-home testing option that delivers results in a mere 15 minutes, without requiring a prescription. This empowers individuals to promptly engage with healthcare providers for subsequent confirmatory testing and appropriate care.
Dr. Michelle Tarver, M.D., Ph.D., acting director of the FDA’s Center for Devices and Radiological Health, emphasizes the significance of this advancement: “We continue to witness progress in diagnostic tests, especially for sexually transmitted infections. These innovations equip patients with greater insights into their health within the comfort of their homes. Home-based testing can play a crucial role in expanding initial syphilis screening, particularly among individuals who might hesitate to consult a healthcare provider for potential STI exposure. This, in turn, can facilitate increased confirmatory lab testing, leading to more timely treatment and a reduction in the transmission of infection.”
Recognizing the escalating crisis of syphilis and congenital syphilis cases nationwide, the Department of Health and Human Services (HHS) established the National Syphilis and Congenital Syphilis Syndemic (NSCSS) Federal Task Force earlier this year. This task force is dedicated to leveraging agency resources, expertise, and stakeholder networks to combat the syphilis epidemic in the U.S. The authorization of the at-home syphilis test directly aligns with the objectives of the HHS’s STI National Strategic Plan, aimed at reversing the alarming rise of STIs across the nation.
Untreated syphilis poses severe health risks, capable of inflicting significant damage to the heart and brain, and leading to blindness, deafness, and paralysis. Furthermore, syphilis transmission during pregnancy can result in miscarriage, enduring health complications for the child, and infant mortality.
It is vital to reiterate that a positive result from the First To Know Syphilis Test is preliminary and necessitates confirmation through laboratory testing by a healthcare provider to establish a definitive syphilis diagnosis. Notably, the test will yield positive results for individuals with a past syphilis diagnosis, even if successfully treated. This test should not be used to self-manage treatment decisions without consulting a healthcare professional. Individuals suspecting recent syphilis exposure should seek medical advice and evaluation irrespective of the test outcome.
As with any diagnostic test, potential risks include false positive and false negative results. False negatives may delay necessary treatment, potentially leading to disease progression and further spread of infection. Conversely, false positives could trigger unnecessary follow-up testing and delay accurate diagnosis of the actual condition.
The FDA evaluated this test through the De Novo premarket review pathway, designated for novel, low-to-moderate-risk devices. Alongside this De Novo authorization, the FDA is implementing special controls concerning labeling and performance testing. Adherence to these controls, in conjunction with general controls, ensures a reasonable assurance of safety and effectiveness for this type of test. This action establishes a new regulatory classification, streamlining the path for subsequent similar devices to gain marketing authorization through the 510(k) premarket process, potentially saving developers time and resources.
This announcement builds upon the FDA’s previous authorization of the first diagnostic test for chlamydia and gonorrhea with at-home sample collection, marking a continued expansion of accessible STI testing options.
This progression in accessible testing underscores the critical role of proactive health management. By facilitating earlier detection, this at-home syphilis test embodies the principle that Care Enables Earlier Diagnosis, empowering individuals to take control of their health and contribute to broader public health efforts in combating the syphilis epidemic.
