US-based diagnostic tests provider NOWDiagnostics (NOWDx) has received the US Food and Drug Administration (FDA) marketing authorisation for its rapid syphilis test, First To Know.
First To Know is a patented buffer-less lateral flow test that detects Treponema pallidum (syphilis) antibodies using a drop of blood from people suspected of having syphilis infection.
It is the first at-home syphilis test approved for over-the-counter (OTC) use in the US, designed to provide test results within 15 minutes.
The test results alone are not adequate to diagnose syphilis infection and should be followed by additional testing to confirm a diagnosis of syphilis, said the US FDA.
The US health agency granted the marketing authorisation under its de novo pathway, which identifies First To Know as a novel device for syphilis testing in the US.
FDA’s Center for Devices and Radiological Health acting director Michelle Tarver 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.”
NOWDx said that syphilis has re-emerged at a distressing rate in the US in nearly every demographic group and region, including newborns.
Between 2018 and 2022, Syphilis cases increased by 80% to more than 207,000, according to the Centers for Disease Control and Prevention (CDC) report.
Also, more than 3,700 cases of congenital syphilis were documented among newborns in 2022, which is 10-fold the number diagnosed in 2012, said the report.
In a clinical study of 1,270 people, First To Know showed a 99.5% NPA (negative percent agreement), which means the test accurately identified 99.5% of negative specimens.
In addition, the test showed a 93.4% PPA (positive percent agreement), which indicates 93.4% of positive specimens are accurately identified, compared to three FDA-approved tests.
NOWDx CEO Rob Weigle said: “FDA granting De Novo authorisation of our First To Know Syphilis Test could not have come at a more important juncture in our country’s efforts to slow the rise of syphilis.
“Testing is one of the most important tools we have in preventing the spread of sexually transmitted infections, and 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.”
