CAP
Lung Cancer Groups Seek Public Comment on Updated Biomarker Testing Guidelines
Updated guidelines recommend certain biomarker tests for early- and late-stage lung cancer at the time of diagnosis.
Despite Broad Carve-Outs, FDA Final Rule on LDTs Draws Critical Response From Lab Industry
The rule makes explicit that LDTs are subject to FDA oversight but provides for enforcement discretion across a broad range of tests.
CAP Releases Testing Guidelines for Immunotherapy Biomarkers in NSCLC
The guidelines focus on how pathologists use approved assays or LDTs, how the results are reported, and which patients should be tested.
In Brief This Week: Syros Pharmaceuticals, AdrenoMed, Telo Genomics, Aspira Women’s Health
News items for the week of April 8, 2024.
CAP Updates Guidelines for Validation of Immunohistochemical Assays
The update takes into consideration evidence published since the release of the original guideline and provides new recommendations on how to analytically validate IHC assays.
Jun 29, 2023
Aug 8, 2022