Syphilis testing typically requires obtaining a blood sample and sending it to a lab. The wait for results ranges from hours to days. The FDA has authorized a new at-home syphilis test, a ...

Other at-home syphilis tests currently on the market require consumers to send their sample to a lab, the FDA said. The at-home syphilis test, which is available without a prescription, gives ...

The first at-home, over-the-counter antibody test for syphilis received marketing authorization from the U.S. Food and Drug Administration (FDA) on Friday. This means biotechnology company ...

The First To Know ® Syphilis Test is now available for purchase nationwide to be used for at-home testing of suspected syphilis infection.. Cleared by the Food and Drug Administration (FDA ...

Compared with 3 FDA-cleared laboratory tests, the First to Know test correctly identified 99.5% (95% CI, 98.9-99.8) of negative specimens and 93.4% (95% CI, 87.0-96.8) of positive specimens.

Between 2018 and 2022, reported syphilis cases increased 80% in the United States between 2018 and 2022, according to the CDC.

However, the NOWDx test alone cannot be used to officially diagnose a syphilis infection; a follow-up with a laboratory test is needed. Being an antibody test, it will return a positive result for ...

Labcorp to serve as the exclusive NOWDiagnostics (NOWDx) distributor for clinical testing in the U.S., offering First to Know® Syphilis Test nationwide BURLINGTON, N.C., Oct 10, 2024 /PRNewswire ...

The first at-home syphilis test has been approved for sale in the US as the worsening epidemic and decades-long rise in cases continues.. The Food and Drug Administration granted approval Friday ...

After the Alexandria Health Department shared that Alexandria had higher rates of syphilis than the region and state, a public clinic is stepping in to help. Neighborhood Health, a federally-qualified ...

Any test result should be confirmed via a lab test arranged through a doctor's visit, the FDA stressed FRIDAY, Aug. 16, 2024 (HealthDay News) -- As syphilis cases surge throughout the United ...