Clinical Lab Management
News on issues related to managing clinical laboratories.
The proposed rule, which is likely to face industry challenges, calls for a four-year phase-in of LDT regulation while also suggesting possible carve-outs.
FDA Releases Proposed Rule for Oversight of Laboratory-Developed Tests
The rule, which would make explicit FDA's authority to regulate LDTs, is certain to face pushback from many in the laboratory and diagnostics industries.
Association for Molecular Pathology Releases CYP3A4 and CYP3A5 Genotyping Recommendations
The AMP Pharmacogenetics Working Group recommended four alleles for a minimum panel (tier 1) and one allele for an extended panel (tier 2).
Quest Diagnostics to Acquire Liquid Biopsy Firm Haystack Oncology for up to $450M
The lab testing giant will add Haystack's minimal residual disease technology to its suite of genomic and other clinical services.
Quest Adds to Cancer Portfolio With $450M Buy of Haystack Oncology; Q1 Revenues Down 11 Percent
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The firm said the acquisition let it move into the "fast growing" MRD space and round out its offerings in cancer screening, pathology, and sequencing.