While labs overwhelmingly welcomed the ruling, it could make it more difficult for firms that want FDA's imprimatur for LDTs ...
Eliminating Kickbacks in Recovery Act (EKRA) enforcement remains uncertain for clinical laboratories, even after the Ninth Circuit’s Schena ...
On December 1, 2025, the First Circuit Court of Appeals delivered a decision that should bring welcome relief to clinical ...
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 ...
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