LDTs
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.
New York State DOH Approves Biotia's AI-, Sequencing-Based Urinary Tract Infection Test
The laboratory-developed test uses shotgun metagenomic sequencing to identify pathogens that cause urinary tract infections.
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FDA Issues Draft Guidance on Process for Modifying Medical Devices Including Lab Tests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.