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BIOTECHNOLOGY

Medical Device News Magazine reports breaking biotechnology news including new biotech developments, pharmaceuticals and more.

PangenomiX Array

Thermo Fisher Scientific Launches PangenomiX Array to Support Population-Scale Disease Studies and Pharmacogenomics Research

The PangenomiX Array is currently the only research solution that combines four assays in one test: SNP genotyping, whole genome copy number variant detection, fixed copy number discovery, blood and HLA typing. The high-throughput array is designed to advance disease risk and detection research, population-scale disease research programs, ancestry and wellness testing, drug efficacy testing, and drug development research.

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Amgen Provides Regulatory Update on the Status of Lumakras® (Sotorasib)

This review, which resulted in a Complete Response Letter, was based on the CodeBreaK 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer. The FDA also issued a new postmarketing requirement for an additional confirmatory study to support full approval that will be completed no later than February 2028.

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