The onset of COVID-19 proved to be a real-time stress test of America’s clinical testing system. The experience exposed several flaws in the system that policymakers should address, specifically, ...

Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, and used within a single licensed clinical laboratory ...

After introducing a user fee reauthorization draft in May, the Senate recently added a new proposal that would revamp the Food and Drug Administration’s regulation of clinical tests and diagnostics.

The Food and Drug Administration released a final rule on Monday strengthening its authority over laboratory developed tests (LDTs), advancing a policy that has drawn fierce opposition from healthcare ...

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 ...

This article is the third in Microbiologics’ series on Optimal QC in the Clinical Laboratory. Previously, in this series we highlighted the importance of external and third-party quality control ...