Dive Brief:
- The Food and Drug Administration granted market authorization to NowDiagnostics’ at-home syphilis blood test, the first diagnostic of its kind.
- NowDiagnostics’ rapid over-the-counter test can deliver results in 15 minutes with a single drop of blood. The test, called the First To Know Syphilis Test, was authorized through the FDA’s de novo pathway; other similar products could follow under the agency’s less rigorous 510(k) pathway going forward.
- The antibody test can detect current or past syphilis infection. The FDA noted in a Friday announcement that the test alone is not sufficient to diagnose syphilis and “should be followed by additional testing to confirm” a diagnosis.
Dive Insight:
The authorization comes as the syphilis rate in the U.S. is climbing. Syphilis cases in the U.S. increased from about 115,000 to more than 207,000 between 2018 and 2022, an 80% jump, according to a January notice from the Centers for Disease Control and Prevention. The CDC said the number of cases in 2022 was the highest since the 1950s.
Syphilis can lead to serious health issues if untreated, such as damage to the heart and brain, blindness and deafness. The FDA’s Center for Devices and Radiological Health said the at-home test, which can be bought without a prescription, could increase diagnosis and treatment rates.
“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,” Michelle Tarver, the CDRH’s acting director, said in the announcement. “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.”
In a clinical study of more than 1,200 people comparing multiple FDA-cleared laboratory tests, NowDiagnostics’ test correctly identified 99.5% of negative specimens and 93.4% of positive specimens, according to the company.
This is the latest at-home diagnostic for sexually transmitted infections the FDA authorized. In November, the agency OK’d LetsGetChecked’s at-home test for chlamydia and gonorrhea. That diagnostic allows patients to collect samples at home and send them to a laboratory for testing. Results are then shared with the patients online.
The LetsGetChecked offering was also the first at-home test to be cleared for the sexually transmitted infections, intended to increase diagnosis and treatment by allowing people to collect samples with more privacy than at a doctor’s office or other healthcare facility.