Congress Holds Off on Enabling FDA Regulation of Clinical Laboratory-Developed Tests

Supporters of the VALID Act say lobbying blitz by academic medical centers prevented its passage In 2022, a bill before Congress titled the Verifying Accurate Leading-Edge IVCT Development Act (VALID Act) sought to change the current regulatory scheme for clinical laboratory-developed tests (LDTs) and in vitro clinical tests (IVCTs). But even though the College of American Pathologists (CAP) and nine other organizations signed a December 12 stakeholder letter to leaders of key House and Senate...

Virginia Commonwealth University Scientists Combine dPCR and High-Speed Microscopic Imaging to Reduce Cost of Diagnosing Cancers

VCU scientists used the technique to measure mutations associated with acute myeloid leukemia, potentially offering an attractive alternative to DNA sequencing More accurate but less-costly cancer diagnostics are the Holy Grail of cancer research. Now, research scientists at Virginia Commonwealth University (VCU) say they have developed a clinical laboratory diagnostic technique that could be far cheaper and more capable than standard DNA sequencing in diagnosing some diseases. Their method...
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