The Food and Drug Administration on Friday authorized the first at-home syphilis test amid surging cases of the bacterial ...
(The Hill) – The Food and Drug Administration (FDA) granted market authorization to the first at-home syphilis test amid a decades-long rise of cases in the U.S. The test, which detects syphilis ...
On October 7, 2024, FDA granted marketing authorization for the over‑the‑counter combination flu and COVID-19 combination test, Healgen Rapid ...
meaning it correctly identified 93.4% of positive specimens when compared to three FDA cleared laboratory tests. Results from the First to Know ® Syphilis Test alone are not sufficient to ...
“We hope this is the first step towards seeing a resolution to this shortage, and that HHS and FDA will continue to take steps to ensure that communities never experience a syphilis treatment ...
Nowdiagnostics Inc. established an exclusive agreement with Laboratory Holdings Inc. for distribution of its First To Know syphilis test in the U.S. The test provides results in 15 minutes with as ...
The only FDA ... first sample. At the lab, a technician will add a chemical to the test samples. They'll change color if blood is present. Fecal immunochemical test (FIT) FIT is the more widely ...
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 ...
“Our collaboration with Labcorp marks a pivotal moment for NOWDx as we scale up access to our First To Know ® Syphilis Test across the U.S.,” said Rob Weigle, CEO of NOWDx. “Labcorp’s ...
Physicians can utilize the test in clinical settings or give it to a patient to conduct in the comfort of their own home ... As the FDA has noted, results from the First to Know Syphilis Test ...
As syphilis cases surge nationwide, the collaboration will bring the First To Know ® over-the-counter test to clinicians and patients across professional and hospital settings SPRINGDALE ...