EGFR Biomarkers News and reporting on EGFR biomarkers. FDA Approves FoundationOne CDx for EGFR Inhibitors to Identify EGFR Mutations in NSCLC The FoundationOne CDx test will be used to identify patients for treatment with FDA-approved EGFR inhibitors. FDA Approves Thermo Fisher Scientific Oncomine Dx Assay as CDx for Janssen Lung Cancer Drug The Oncomine Dx Target Test will be used as a companion diagnostic to identify NSCLC patients whose tumors carry EGFR Exon20-insertion mutations. Molecular Clonal Tracking Method Captures Lung Cancer Treatment Response, Resistance Features Using a single-cell sequencing and clonal fitness mapping method, researchers compared EGFR-mutant lung cancer cell responses to EGFR inhibition or targeted protein degradation. FDA Approves Takeda's Exkivity With Thermo Fisher CDx for EGFR Exon20 Insertion-Positive NSCLC This is the first time the FDA has approved a drug specifically for NSCLC patients who harbor rare EGFR Exon20 insertion mutations. Genecast to Evaluate Liquid Biopsy EGFR Mutation Test in Early-Stage Non-Small Cell Lung Cancer The firm hopes its qPCR-based liquid biopsy test could help identify early-stage NSCLC patients eligible for adjuvant or neoadjuvant anti-EGFR TKI treatment. Jun 8, 2021 Liquid Biopsy-Guided EGFR Rechallenge Therapy Shows Benefit for Colorectal Cancer Patients May 21, 2021 FDA Approves Janssen's Rybrevant, Guardant360 CDx for EGFR Exon 20-Mutated NSCLC Feb 23, 2021 Biocept, Protean BioDiagnostics Team up to Study EGFR Assay in Lung Cancer Oct 29, 2020 Roche EGFR Mutation Test Approved by FDA as Companion Diagnostic for NSCLC Jul 8, 2020 Guardant Health to Develop Liquid Biopsy Companion Diagnostic for Janssen NSCLC Therapy Jun 17, 2020 Stilla Positions Six-Color Digital PCR System for Use in Oncology, Virology, GMO Testing Premium Apr 27, 2020 Amid COVID-19, Lower Cancer Diagnosis Rates Mean Fewer Patients Getting Molecular Tests, Treatment Premium Apr 19, 2020 Despite FDA Guidance, CDx Providers Still Have Challenges in Seeking 'Therapeutic Group' Indication Premium Feb 13, 2020 Genetron Health Obtains Regulatory Approval in China for NGS Instrument, Lung Cancer Panel Jan 22, 2020 Biocartis, AstraZeneca Expand Lung Cancer Biomarker Study With Master Collaboration Agreement Nov 21, 2019 Extrachromosomal Oncogene Amplification Involves Rearrangement of Regulatory Elements Sep 23, 2019 Global Survey Reveals Suboptimal Molecular Testing Access in Lung Cancer Despite Broad Guidelines Premium Aug 5, 2019 IncellDx Inks Chinese Collaboration, Distribution Agreements Jul 23, 2019 China's NMPA Extends Approval for Roche Cobas EGFR Mutation Test v2 to Plasma Samples Jul 18, 2019 Inivata to Test Liquid Biopsy Against Tissue Sequencing in French Prospective Clinical Trial Apr 10, 2019 Foundation Medicine, Flatiron Health Publish Clinical Validity of Clinico-Genomics Database Mar 4, 2019 Colon Cancer Patients Could Benefit From HER2 EGFR Non-Response Findings, Investigators Say Premium Jan 24, 2019 Memorial Sloan Kettering Using Cerebral Spinal Fluid Liquid Biopsy, Sequencing to Track Glioma Evolution Premium Jan 16, 2019 Qiagen EGFR Assay Approved in Japan as CDx to Pfizer NSCLC Drug Nov 29, 2018 Biocartis, AstraZeneca Partner on European Lung Cancer Biomarker Study Load More Breaking News Single-Nucleus Chromatin Accessibility Profiling in Coronary Artery Disease Points to Mechanisms ALL Genomes Marked by High DNA Methylation Levels Cepheid Gets CE Mark for Updated Rapid COVID MDx Test Mainz Biomed, Dante Labs Partner to Commercialize ColoAlert in Europe, UAE CellCarta Acquires Rights to Targeted Protein Assays from Fred Hutch Spinout Precision Assays Genetic Analysis, Omnigene Medical Technologies Ink Distribution, Tech Transfer Deal The Scan Monkeypox Case Found in US The New York Times says that a case of monkeypox has now been reported in the US. Effects on Fetal Screening Wired writes that changes to US abortion laws could affect screening for fatal congenital conditions. 'Pharma Bro' Out of Prison The Wall Street Journal reports that Martin Shkreli has been released from prison to a halfway house. Nature Papers Present Cultivate Oat Genome, Benchmarking of Spatial and Single-Cell Transcriptomic Integration Methods In Nature this week: reference genome of the cultivated oat, and more.