The US Food and Drug Administration is proposing to step up its oversight of a growing category of medical tests called laboratory-developed tests. The FDA approves and clears many types of lab tests ...

Company to Draw on Substantial Experience with COVID Testing to Again Support Public Health Agencies if Needed GAITHERSBURG, Md., May 22, 2026 ...

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 ...

Clinical Laboratory Improvement Amendments, or CLIA, are a high bar as set by the US Government under Clinical Laboratory Improvement Amendment 42 CFR 493.1253 to obtain and maintain quality ...