FDA Approves First Over-The-Counter Syphilis Test

CNN (8/16, Christensen) reported the FDA “authorized the first at-home over-the-counter test for syphilis Friday.” Developed by NOWDiagnostics, the First To Know Syphilis Test “will take the user just 15 minutes and a single drop of blood to determine whether they have syphilis.” The Washington Post (8/16, Roubein) reported NOWDiagnostics “anticipates the 15-minute test being available in pharmacies, major retail stores and online as early as September.” The FDA has “hailed the new product as an advancement in testing for sexually transmitted illnesses but noted that an additional test by a health-care provider is needed to confirm a positive result.” MedPage Today (8/16, Kahn) reported that in a clinical study, the test “showed a negative percent agreement of 99.5% and a positive percent agreement of 93.4%.” Its approval “follows last year’s authorization of the first at-home sample collection test for chlamydia and gonorrhea, which was the first FDA-authorized at-home test for any sexually transmitted infection other than HIV.” Also reporting were Reuters (8/16, Sunny), Healio (8/16, Bagha), and HealthDay (8/16, Mundell).