FDA
Final FDA Guidance Lays Path for Drugmakers to Establish Circulating Tumor DNA as Trial Endpoint
The guidance provides the agency's thoughts on the emerging use of ctDNA residual disease testing to select patients for treatment in trials of new adjuvant therapies.
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.
Diasorin Submits Gram-Positive Bacteria Panel for FDA 510(k) Clearance
The Gram-positive blood culture assay is the firm's third panel for the detection and identification of bloodstream pathogens using the Liaison Plex instrument.
Caris Life Sciences CDx Assay Nabs FDA Approval
The whole-exome sequencing and whole-transcriptome sequencing-based test is approved for molecular profiling of solid tumors.
Aug 23, 2024
Aug 5, 2024