KRAS Biomarkers
FDA Approves Entrogen's RAS Mutation Detection Kit as CDx for Vectibix
The test, intended for use with Amgen's Vectibix, detects KRAS and NRAS exon 2, 3, and 4 mutations in colorectal cancer patients.
Quest Diagnostics to Offer Agilent Companion Test for Mirati Therapeutics NSCLC Treatment
Agilent's companion diagnostic for Mirati's non-small cell lung cancer treatment Krazati will be available through Quest's national healthcare network.
Pillar Biosciences Receives China Approval for Colon Cancer Companion Diagnostic Assay
The OncoReveal Dx Colon Cancer Assay is intended for use on the Illumina MiSeq Dx, and now has approvals in China, the US, and Europe.
Amoy Diagnostics, Amgen Partner on Lung Cancer CDx Development for Lumakras in Japan
Amoy Diagnostics will develop its PCR-based panel as a companion diagnostic in Japan to screen NSCLC patients for Amgen's KRAS G12C inhibitor.
FDA Approves Amgen's Lumakras for NSCLC Alongside Companion Tests From Guardant Health, Qiagen
The approval makes Lumakras the first inhibitor of KRAS, once considered "undruggable," to reach the market for KRAS-mutated NSCLC.