The FDA has finalized its regulatory rule that aims to bring laboratory-developed tests more in-line with how the agency oversees other diagnostics. At its heart, the 528-page final rule (PDF) looks ...

Influenza is a common disease that occurs in yearly epidemics throughout the world. Although the majority of infected individuals will exhibit a self-limited acute febrile illness or remain ...

Medical laboratory testing is the heartbeat of medicine. It provides critical data for physicians to diagnose and treat disease, dating back thousands of years. Unfortunately, laboratory medicine as a ...

In September 2020, the SD Biosensor STANDARD Q COVID-19 Ag Test became the first rapid antigen test ever listed under WHO’s ...

Diagnostic test developers, including clinical laboratories, responded to the COVID-19 pandemic with inspiring creativity to meet patient testing needs. These developers found unique ways to enable ...

The Defense Health Agency has extended a pilot program that covers many now-common laboratory genetic tests and added five more to improve diagnostics and care for patients with breast, blood and ...

There are several lab tests for hemophilia. However, the main tests detect the clotting activity of factors VIII and IX, which are proteins in the blood. Hemophilia is a bleeding disorder in which an ...

New findings from the RECOVER-Adult cohort study show that 25 routine clinical lab tests are not effective in diagnosing postacute sequelae of SARS-CoV-2 infection, echoing results from earlier ...

The DoD’s premiere Food Analysis and Diagnostic Laboratory (FADL) protects U.S. Service Members and their Families by ensuring food safety, food fitness for consumption, and contractual compliance ...