FDA marketing authorization enables increased access to first step of syphilis diagnosis
The U.S. Food and Drug Administration granted marketing authorization to NOWDiagnostics for the First to Know Syphilis Test.
This is the first at-home, over-the-counter test to detect Treponema pallidum (syphilis) antibodies in human blood. Results from this type of test alone are not sufficient to diagnose syphilis infection and should be followed by additional testing to confirm a diagnosis of syphilis.
The test provides an at-home result without a prescription, in approximately 15 minutes, which individuals can use to better inform next steps with a healthcare provider.
As noted above, positive test results from this test alone are not sufficient to diagnose syphilis infection and should be followed by additional laboratory testing through a healthcare provider to confirm a diagnosis of syphilis. Results of this test will be positive for individuals previously diagnosed with syphilis, even if they were successfully treated. Results of the test alone should not be used to start, stop or change any treatments without a healthcare provider. In addition, individuals using this test who may have been recently exposed to syphilis should seek care from a healthcare provider for treatment and evaluation regardless of this test’s results.
As with many other tests, the risks associated with this test are mainly the possibility of false positive and false negative test results.
The FDA reviewed this test under the FDA’s De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device, which may save a developer time and expense compared to other review pathways.
This announcement follows last year’s authorization of the diagnostic test for chlamydia and gonorrhea with at-home sample collection, which was the first FDA-authorized test with at-home sample collection for any sexually transmitted infection other than HIV.
