A group representing clinical labs across the country sued the Food and Drug Administration on Wednesday over the agency’s plan to actively regulate lab-developed tests. The suit, filed in a Texas ...

CHICAGO – The principal lab for a nationwide coronavirus testing company under investigation by several states is now the focus of a federal agency probing allegations of misconduct at the site. The ...

LOS ANGELES--(BUSINESS WIRE)--BiologyWorks™, Inc., a digital healthcare platform company, today announced that a substantive clinical trial of its handheld, reusable molecular test for COVID-19 ...

Egan indicated all four indications—COVID-19, multiplex flu A/B, COVID-19 and RSV test, TB, and HPV—are expected to enter clinical trials during the remainder of 2025. "We anticipate to begin with the ...

Denton, Texas-based PCR clinical lab HealthTrackRx opened a location in Marietta, Ga. HealthTrackRx said March 24 that the new Georgia lab will offer a comprehensive menu of next-day infectious ...