FDA approves first over-the-counter syphilis test

The US Food and Drug Administration (FDA) has granted marketing authorization for the first at-home, over-the-counter test to detect Treponema pallidum (syphilis) antibodies.¹

The blood-based First To Know Syphilis Test, from NOWDiagnostics, was granted authorization from the FDA today with an expressed sentiment that the product will support patient privacy when testing for a potential sexually transmitted infection (STI). Though the product was advised to only indicate the need for a definite diagnostic test by a clinician, it can help to destigmatize STI risk monitoring—a key need at a time when syphilis cases have increased by 80% in the US since 2018.

“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,” Michelle Tarver, MD, PhD, acting director of the FDA’s Center for Devices and Radiological Health, said in a statement accompanying the authorization. “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 further noted that the results of the First To Know test are not sufficient to make a certain syphilis infection diagnosis—successfully treated patients with prior syphilis can still test positive with the product. Patients are advised to seek additional laboratory testing coordinated through a health care provider based on their results.

The at-home test is capable of providing results to consumers within approximately 15 minutes. The FDA believes its authorization will help toward the Department of Health and Human Services’ (HHS) National Syphilis and Congenital Syphilis Syndemic Federal Task Force’s objective to reverse the climb of STI cases in the US.

Indeed, recent data from the World Health Organization (WHO) indicated that the institution’s own effort to reduce global rates of syphilis have been recently challenged; despite their strategy to reduce annual infection diagnoses 10-fold by 2030, annual cases climbed from 7.1 million to 8.0 million in 2022.²

References

1. ^{US Food & Drug Administration. FDA Marketing Authorization Enables Increased Access to First Step of Syphilis Diagnosis. Press release. Published August 16, 2024. https://www.fda.gov/news-events/press-announcements/fda-marketing-authorization-enables-increased-access-first-step-syphilis-diagnosis?utm_medium=email&utm_source=govdelivery}
2. ^{Abene S. Escalating STI rates undermine global health progress towards 2030 targets. Contemporary OB/GYN. Published May 23, 2024. Accessed August 16, 2024. https://www.contemporaryobgyn.net/view/escalating-sti-rates-undermine-global-health-progress-towards-2030-targets}