FDA authorizes Over-the-Counter Syphilis test for home use

USA—The United States Food and Drug Administration (FDA) has granted NOWDiagnostics marketing authorization for its First To Know Syphilis Test, marking a significant milestone in home healthcare.

This is the first over-the-counter, at-home diagnostic technique for detecting Treponema pallidum (syphilis) antibodies in human blood.

The clearance comes after the FDA approved the first at-home diagnostic test for chlamydia and gonorrhea last year, making it the first test for sexually transmitted infections (STIs) other than HIV to include at-home sample collection.

The FDA evaluated the First To Know Syphilis Test using its De Novo premarket review pathway, a regulatory process for innovative, low—to moderate-risk products.

In conjunction with this authorisation, the FDA establishes special rules to outline the labelling and performance testing criteria for such tests.

These particular controls, together with general controls, are intended to reasonably guarantee safety and effectiveness for experiments of this type.

Previously, there were no over-the-counter diagnostics to let people diagnose a possible syphilis infection on their own.

This new test provides results in around 15 minutes and does not require a prescription, allowing consumers to make more informed decisions about seeking follow-up care from a healthcare provider.

However, NOWDiagnostics emphasises that a single test result is insufficient for detecting syphilis. Positive results must be confirmed with additional tests to ensure a correct diagnosis.

Michelle Tarver, M.D., Ph.D., acting head of the FDA’s Centre for Devices and Radiological Health, emphasised the FDA’s ongoing progress in STI testing.

She pointed out that such developments allow patients to access more information about their health from the comfort and privacy of their own homes.

 Dr Tarver also suggested that expanding access to home testing could increase first syphilis screening rates, particularly among people who are hesitant to consult healthcare providers about probable STI exposure.

This could result in further lab tests for confirmation, thereby raising treatment rates and lowering infection transmission.

The Centers for Disease Control and Prevention (CDC) states that syphilis cases in the United States increased by 80% between 2018 and 2022, jumping from 115,000 to over 207,000. This development highlights the growing need to address syphilis and other STIs adequately.

In response, the Department of Health and Human Services (HHS) formed the National Syphilis and Congenital Syphilis Syndemic (NSCSS) Federal Task Force earlier this year.

The task group intends to use federal agencies, knowledge, and stakeholder networks to battle the syphilis pandemic.

The approval of the First To Know Syphilis Test is an essential step towards meeting the goals of the STI National Strategic Plan, which aims to reverse the recent increase in STIs in the United States.

Untreated syphilis can cause severe complications such as heart and brain damage, blindness, deafness, and paralysis.

 Furthermore, syphilis transmitted during pregnancy can cause miscarriage, long-term severe medical problems for the infant, or even newborn death.

This new test is a promising tool in the ongoing fight to control and prevent syphilis while also improving public health outcomes.

Sign up to receive our email newsletters with the latest news updates and  insights from Africa and the World HERE