FDA Greenlights First At-Home, Over-the-Counter Syphilis Diagnostic Test Amidst STD Increase

The FDA recently authorized the first at-home syphilis antibody test, marking a significant advance in public health. As STD cases spike in the US, this test enables individuals to conveniently detect infection and potentially reduce transmission rates. Marketing authorization for the test was granted via the de novo pathway, classifying it as a new device for syphilis testing in the US. This approval sets it apart from existing products on the market. The authorization represents a major step forward in disease management.

FDA Approves NOWDiagnostics’ First At-Home, 15-Minute Syphilis Test Amid Rising STD Cases

Typically, syphilis testing involves taking a blood sample and sending it to a lab, with results taking hours to days. However, the FDA has approved a new at-home syphilis test from NOWDiagnostics that delivers results in just 15 minutes. NOWDiagnostics, based in Springdale, Arkansas, will market this test under the name First To Know.

Syphilis has surged alarmingly across the U.S. affecting nearly every demographic and region, including newborns. The Centers for Disease Control and Prevention (CDC) reports an 80% increase in cases, rising to over 207,000 between 2018 and 2022. In 2022, doctors recorded over 3,700 cases of congenital syphilis in newborns, a tenfold increase since 2012. Syphilis, caused by the bacterium Treponema pallidum, is treatable with antibiotics like penicillin. Untreated syphilis can severely damage the heart and brain, leading to blindness, deafness, and paralysis. Additionally, during pregnancy, it can result in miscarriage, severe medical issues, and infant death. Many individuals with syphilis often do not show symptoms.

First To Know Detects Treponema pallidum Antibodies with Just a Single Drop of Blood

The First To Know test uses a single drop of blood to detect Treponema pallidum antibodies. The FDA approved this test based on a clinical study involving 1,270 participants. Researchers compared First To Know results with those from three FDA-cleared laboratory tests. The data revealed a negative percent agreement of 99.5%, indicating the test accurately identified 99.5% of negative samples. Additionally, the positive percent agreement was 93.4%, showing the test correctly identified positive specimens.

However, the FDA warns that First To Know carries risks similar to other diagnostic tests, including potential false positives or false negatives. Therefore, positive results from this test do not confirm a syphilis diagnosis and require follow-up testing for confirmation.

“There is a critical need to increase public awareness about the seriousness of untreated syphilis, especially in underserved and marginalized populations,” said Dr. Gregory Bledsoe, former surgeon general of Arkansas, in NOWDx’s announcement of the regulatory decision. “An in-home test like this has the potential to greatly impact public health by improving access to timely detection and treatment.”

NOWDx’s First To Know: FDA Authorizes Over-the-Counter Syphilis Test with $22.5 Million in New Funding

NOWDx specializes in over-the-counter and point-of-care diagnostic tests. The company claims its technology enables any immunological assay to be conducted in a single step with just a small blood sample. Additionally, NOWDx is developing tests that can analyze saliva samples. Alongside First To Know, NOWDx offers blood tests for pregnancy and Covid-19, and it has over 30 tests in its development pipeline.

The FDA reviewed First To Know using the De Novo premarket review pathway for new devices with low-to-moderate risk. This approval establishes First To Know as a predicate device, creating a new regulatory classification. Consequently, future similar tests can be compared to First To Know through the FDA’s 510(k) pathway.

First To Know will be available without a prescription. NOWDx anticipates that this new syphilis test will hit retail stores and online platforms later this year. Last month, the company secured $22.5 million in new funding to support the commercialization of First To Know. The Series B round, led by DigitalDx Ventures, also included contributions from Labcorp Venture Fund and Kompass Kapital Management.

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Author

Bernice Lottering