FDA
In Brief This Week: Myriad Genetics, Thermo Fisher Scientific, DeepUll, Roche, Immunovia, More
News items for the weeks of Nov. 25 and Dec. 2, 2024.
Called the Coalition for Effective Diagnostics, the organization has called on lawmakers to pass legislation revamping diagnostics regulation, including oversight of LDTs.
FDA Approves Roche CDx Test for Use With Jazz Pharmaceuticals Drug in Biliary Tract Cancer
The approval is for a new indication for Roche's existing Pathway HER2 (4B5) test and is intended to identify patients with HER2-positive biliary tract cancer.
Association for Molecular Pathology 'In Limbo' as FDA Lawsuit Moves Ahead, LDT Regulations Loom
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At the AMP annual meeting this week, leadership briefed members on what to expect as its lawsuit challenging the FDA final rule on laboratory-developed test regulation unfolds.
Foundation Medicine Companion Dx Test Gets FDA OK for Use with Merck's Tepmetko in Lung Cancer
The blood-based comprehensive genomic profiling test uses next-generation sequencing to analyze 324 genes.
Nov 6, 2024
Caris Life Sciences CDx Assay Nabs FDA Approval
Oct 23, 2024
Oct 2, 2024