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Diving certificate:
- The Food and Drug Administration granted market authorization for the home syphilis blood test from NowDiagnostics, the first diagnostic device of its kind.
- Rapid non-prescription test from NowDiagnostics can deliver results in 15 minutes with a single drop of blood. The test, called the First To Know Syphilis Test, was approved under the FDA’s de novo process; other similar products could follow in the future under the agency’s less stringent 510(k) process.
- THe Antibody tests can detect current or past syphilis infection. The FDA noted in a statement Friday that the test alone is not enough to diagnose syphilis and that “additional testing should be done to confirm” a diagnosis.
Diving insight:
The authorization comes as the syphilis rate in the USA rising. Syphilis cases in the U.S. rose from about 115,000 to more than 207,000 between 2018 and 2022, an increase of 80%, according to a January release from the Centers for Disease Control and Prevention. The CDC said the number of cases in 2022 was the highest since the 1950s.
If left untreated, syphilis can lead to serious health problems, such as heart and brain damage, blindness and deafness. The FDA’s Center for Devices and Radiological Health said the over-the-counter home test could increase diagnosis and treatment rates.
“We continue to see advances in testing, particularly sexually transmitted infection testing, which can give patients more information about their health in the privacy of their own home,” said Michelle Tarver, the acting director of the CDRHthe announcement states. “Access to home testing can help increase initial screening for syphilis, including among individuals who may be hesitant to see their health care provider about possible exposure to sexually transmitted infections.”
In a clinical trial of more than 1,200 people comparing several FDA-approved laboratory tests, NowDiagnostics’ test correctly identified 99.5% of negative samples and 93.4% of positive samples, according to the company.
This is the latest home diagnostic for sexually transmitted infections approved by the FDA. In November, the agency OK for the LetsGetChecked home test for chlamydia and gonorrhea. For this diagnosis, patients can take samples at home and send them to a laboratory for testing. The results are then communicated to the patient online.
LetsGetChecked’s service was also the first approved home test for sexually transmitted infections and is designed to improve diagnosis and treatment by allowing people to have their samples collected more confidentially than in a doctor’s office or other healthcare facility.
