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, ...

In May 2024, FDA finalized a rule regarding LDTs, which purported to amend the 21 CFR 809.3(a) definition of "in vitro diagnostic products" to specify that such definition "[includes] when the ...

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 ...

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 ...

ROCKVILLE, Md. – August 19, 2024 – The Association for Molecular Pathology (AMP), the premier global molecular diagnostic professional society, and world-renowned pathologist Michael Laposata, MD, PhD ...

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 ...

ROCKVILLE, Md. – May 27, 2025 – The Association for Molecular Pathology, the premier global molecular diagnostic professional society, today announced the release of a three-part series of scientific ...

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 ...