FDA
FDA Approves Illumina Cancer Genomic Profiling Assay as CDx for Kinase Inhibitors From Bayer, Lilly
The test's first CDx approvals are for Bayer's Vitrakvi in solid tumors and for Lilly's Retevmo in non-small cell lung cancer.
Global organizations are calling for an increase in diagnostic tests — particularly point-of-care molecular assays — to meet the challenge of a new outbreak.
FDA IVD Reclassification Plan May Reduce Regulatory Burden for Test Developers, But Questions Remain
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The plan, announced in January, would reclassify many Class III in vitro diagnostic devices as Class II, impacting companion diagnostic and infectious disease tests.
FDA Issues Draft Guidance on Process for Modifying Medical Devices Including Lab Tests
The guidance covers predetermined change control plans, which some in the lab industry are looking to for flexibility following FDA's recent rule on lab-developed tests.
AMP Sues FDA Over Laboratory-Developed Test Final Rule
Filed in the US District Court for the Southern District of Texas, the lawsuit is the second legal challenge to the rule following a suit filed by ACLA in June.