Companion Diagnostics
News on companion diagnostics and drug/test co-development.
In Brief This Week: Innorna, Sophia Genetics, AstraZeneca, Baylor Genetics, Mainz Biomed, Roche
News items for the week of April 28, 2025.
EntroGen Colorectal Cancer RAS Mutation Detection Test Nabs CMS Coverage
The real-time PCR-based companion diagnostic test identifies patients eligible for treatment with Amgen's Vectibix (panitumumab).
Agilent Gains IVDR Certification for Expanded Use of CDx Assay for Keytruda
The PD-L1 IHC 22C3 PharmDx (Code SK006) assay is now certified for use to aid treatment decisions for patients with gastric or gastroesophageal junction adenocarcinoma.
Pillar Biosciences Receives CMS Coverage for Pan-Cancer CDx Assay
The firm's next-generation sequencing-based test detects single nucleotide variants, insertions, and deletions in 22 genes.
Invivoscribe Acute Myeloid Leukemia Assay Nabs Regulatory Compliance in UK, Switzerland
The test detects FLT3 mutations, which are associated with poor prognosis in acute myeloid leukemia patients.