NOWDiagnostics has secured de novo clearance from the US Food and Drug Administration (FDA) for First To Know, an at-home syphilis test.
With the FDA clearance, the test, which gives users a result within 15 minutes from a blood sample, becomes the first over-the-counter (OTC) test in the US to detect Treponema pallidum (syphilis) antibodies in human blood.
Recent data from the Centers for Disease Control and Prevention (CDC) indicates that 203,500 cases of syphilis and 3,755 of congenital syphilis were reported in the US in 2022, a respective rise from 113,739 and 1,325 in 2018. Left untreated, syphilis can potentially result in damage to the heart and brain, and cause blindness, deafness, and paralysis.
“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,” said NOWDiagnostics CEO Rob Weigle.
In response to the rising incidence of syphilis and congenital syphilis nationwide, the US Department of Health and Human Services (HHS) launched the National Syphilis and Congenital Syphilis Syndemic (NSCSS) taskforce in April.
The task force aims to expand access to syphilis testing and has the goal of averting 5% of congenital syphilis cases by September 2024.
“Access to home tests may help increase initial screening for syphilis, including in individuals who may be reluctant to see their healthcare provider about possible sexually transmitted infection exposure,” commented Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health.
According to GlobalData’s medical device pipeline database, 13 syphilis devices are in various stages of development globally.
In April 2024, the FDA issued its Final Rule, making explicit that in vitro diagnostics (IVD) products and laboratory-developed tests (LDT) qualify as medical devices and are therefore subject to pre-market approval.
The ruling has prompted an outcry from participants across the US laboratory industry. Expressing their concerns at the Association for Diagnostics and Laboratory Medicine’s (ADLM) recent conference in Chicago, guest panellists at a special session for the ADLM described the ruling as ‘burdensome’ and went on to cite an internal survey that found that many labs do not have the staff or finances to effectively comply with the new FDA ruling once it comes into full force.
Speaking at the ADLM conference on 30 July, Jeff Hollett, senior science policy analyst for the American Medical Association (AMA), said: “LDTs, as they formerly stood, allowed for physicians to practice at the top of their licence, similar to how a physician can prescribe a medication off label if there is evidence for its use. LDTs allow for physicians and laboratory professionals to diagnose and to treat when there is evidence for their use and FDA approval is far too slow for the rapidly evolving rate of diagnostic medicine.”
