FDA Approves First At-Home Syphilis Test

First To Know Syphilis Test

Image credits: NOWDx

The FDA has granted marketing authorization for NOWDiagnostics’ First To Know Syphilis Test, the first at-home, over-the-counter test for detecting Treponema pallidum (syphilis) antibodies.¹ The test provides results in just 15 minutes using a single drop of blood and is designed for at-home use. The test received FDA authorization via the De Novo pathway, which is used for novel devices.²

In a clinical study involving 1,270 participants, the test demonstrated a 99.5% negative percent agreement, accurately identifying 99.5% of negative specimens. It also achieved a 93.4% positive percent agreement, correctly identifying 93.4% of positive specimens when compared to three FDA-cleared laboratory tests.²

Rob Weigle, CEO of NOWDx, emphasized the significance of this test in combating the syphilis epidemic, noting, “For the first time ever, consumers now have a fast and simple syphilis test that can be performed in the privacy of one’s home, with a result in minutes.” Gregory Bledsoe, MD, MPH, MBA, former Surgeon General of Arkansas, highlighted the test’s potential to enhance public health by improving access to timely detection and treatment.¹

Graphs to show the rise of syphilis cases from 2018-2022.

Image credits: CDC

According to the CDC, cases rose by 80% to over 207,000 between 2018 and 2022. In 2022 alone, over 3,700 cases of congenital syphilis were reported among newborns, 10 times the number in 2012. Untreated syphilis can lead to severe health complications, including heart and brain damage, blindness, deafness, and paralysis. During pregnancy, it can result in miscarriage, lifelong medical problems, and infant death. Many individuals with syphilis may not show symptoms, making detection and treatment crucial.³

Future Implications

The First To Know Syphilis Test is a patented, buffer-less lateral flow device known for its high accuracy when compared to three FDA-cleared laboratory tests. Anticipated to be available at major national retailers and online in the latter half of 2024, the test provides results in approximately 15 minutes.² While it offers rapid results, it is not sufficient for a definitive diagnosis of syphilis and should be followed by confirmatory testing with a healthcare provider.¹

Michelle Tarver, MD, PhD, acting director of the FDA’s Center for Devices and Radiological Health, said, “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.”¹

This approval follows the FDA’s 2023 authorization of the first at-home diagnostic test for chlamydia and gonorrhea. The new syphilis test aligns with broader efforts to enhance STI screening and address rising infection rates in the US.

References

1. FDA Marketing Authorization Enables Increased Access to First Step of Syphilis Diagnosis. FDA. August 16, 2024. Accessed August 16, 2024. https://www.fda.gov/news-events/press-announcements/fda-marketing-authorization-enables-increased-access-first-step-syphilis-diagnosis

2. NOWDiagnostics First To Know® Syphilis Test Receives FDA De Novo Marketing Authorization for Over-the-Counter Use. Businesswire. August 16, 2024. Accessed August 16, 2024. https://www.businesswire.com/news/home/20240816394389/en/NOWDiagnostics-First-To-Know%C2%AE-Syphilis-Test-Receives-FDA-De-Novo-Marketing-Authorization-for-Over-the-Counter-Use

3. CDC’s 2022 STI Surveillance Report underscores that STIs must be a public health priority. CDC. Last reviewed January 30, 2024. Accessed August 16, 2024.https://www.cdc.gov/std/statistics/2022/default.htm