WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has granted marketing authorization to NOWDiagnostics for the First To Know Syphilis Test. This groundbreaking test is the first at-home, over-the-counter option available for detecting Treponema pallidum (syphilis) antibodies in human blood. The test provides results in approximately 15 minutes, offering individuals a quick, private way to screen for potential syphilis infection.
Syphilis cases in the United States have surged by 80% between 2018 and 2022, according to the U.S. Centers for Disease Control and Prevention. Reported cases rose from 115,000 to over 207,000, continuing a troubling upward trend.
Michelle Tarver, M.D., Ph.D., acting director of the FDA’s Center for Devices and Radiological Health, highlighted the importance of this development: “We continue to see advancements in tests, particularly tests for sexually transmitted infections, which can give patients more information about their health from the privacy of their own home. Access to home tests may help increase initial screening for syphilis, including in individuals who may be reluctant to see their health care provider about possible sexually transmitted infection exposure. This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection.”
The FDA reviewed this test under the De Novo premarket review pathway, designated for low- to moderate-risk devices of a new type. This pathway establishes special controls related to labeling and performance testing, ensuring a reasonable assurance of safety and effectiveness for such tests. Future devices of the same type may benefit from a more streamlined 510(k) premarket process, potentially saving time and expense.
The authorization of the First To Know Syphilis Test marks a significant step in combating the syphilis epidemic in the U.S. The Department of Health and Human Services has formed the National Syphilis and Congenital Syphilis Syndemic (NSCSS) Federal Task Force to address the rising cases and support the goals of the STI National Strategic Plan.
It is crucial to note that results from this at-home test alone are not sufficient to diagnose syphilis. Positive results must be confirmed by additional laboratory testing through a healthcare provider. False negative results could delay effective treatment and further the spread of the infection, while false positive results might lead to unnecessary testing and delays in correct diagnosis.
Untreated syphilis can cause severe health issues, including damage to the heart and brain, blindness, deafness, and paralysis. When transmitted during pregnancy, it can result in miscarriage, lifelong medical problems, and infant death.
The FDA’s authorization of this test, following last year’s approval of an at-home test for chlamydia and gonorrhea, represents a substantial advancement in public health, providing individuals with accessible tools to take proactive steps in managing their health.
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