AMP
Pathologists See Value Balance Shift Toward Comprehensive Sequencing for Hematologic Cancers
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At the AMP annual meeting last week, speakers at multiple workshops said their field is reaching a tipping point as the clinical utility of NGS further solidifies.
CMS Final Pricing for Genomic Procedure Codes Leaves Lab, Industry Stakeholders Wanting More
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After going through the gapfill process and releasing final pricing for six codes related to genomic sequencing procedures, the final pricing still has stakeholders worried.
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.
Top Five Articles on 360Dx Last Week: FDA Draft Guidance to Modify Devices; 510(k) Clearances; More
Last week, readers were most interested in a story about draft guidance from the FDA on modifying medical devices without needing another round of regulatory review.
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.