CDx development FDA Approves Janssen's Rybrevant, Guardant360 CDx for EGFR Exon 20-Mutated NSCLC The agency approved amivantamab for non-small cell lung cancer patients harboring EGFR exon 20 mutations, as detected by Guardant Health's blood-based test. Amoy Diagnostics, Merck KGaA Partner for Lung Cancer Companion Diagnostic Development in China AmoyDx will develop and seek regulatory approval in China for a lung cancer PCR panel to be used with Merck's MET inhibitor tepotinib. Genetron, CStone Launch Clinical Trial to Develop CDx for Cancer Drug Avapritinib Avapritinib is sold by Blueprint Medicines as Ayvakit for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation. Thermo Fisher Scientific, Daiichi Sankyo Partner to Develop Non-Small Cell Lung Cancer CDx The assay will identify patients with mutations in HER2 who may be eligible for treatment with a HER2-directed antibody-drug-conjugate developed by Daiichi. Myriad Genetics Seeks Japan Approval for Advanced Pancreatic, Prostate Cancer Companion Diagnostic Myriad has partnered with Japanese firm SRL, a subsidiary of Miraca Group, to commercialize its BRACAnalysis Diagnostic System in Japan. Mar 25, 2020 AmoyDx, Janssen Research and Development Partner on NGS-Based Companion Diagnostic Mar 24, 2020 SkylineDx, BioInvent Collaborate to Characterize Predictive Immunological Signatures for Cancers Mar 12, 2020 Thermo Fisher, Janssen Biotech to Develop CDx for Lung Cancer, Other Indications Dec 4, 2019 FDA Approves Foundation Medicine CDx for Novartis Breast Cancer Drug Piqray Dec 3, 2019 Illumina, ArcherDx Expand Partnership on NGS IVD Tests Nov 25, 2019 Asuragen, Wave Life Sciences to Develop Companion Diagnostics for Huntington's Disease Therapies Nov 6, 2019 Merck, Promega Collaborate to Develop MSI CDx for Keytruda Oct 8, 2019 Novogene, Chipscreen Ink CDx Development Deal Oct 7, 2019 Qiagen Partners With Illumina on NGS IVD Kits; CEO Departing; Preliminary Q3 Revenue Growth Lowered Sep 9, 2019 Thermo Fisher Scientific, Eli Lilly to Develop CDx for RET Inhibitor Jul 1, 2019 FDA Approves Foundation Medicine CDx Test for Lynparza May 30, 2019 Caris Life Sciences Inks CDx Collaboration With Debiopharm Apr 4, 2019 Myriad Genetics, AstraZeneca, Merck Expand BRCA CDx Collaboration Dec 7, 2018 Novartis Drug Shows Promise in PIK3CA Mutated Breast Cancer, Potential Utility of ctDNA Testing Premium Oct 16, 2018 FDA Approves Myriad Genetics BRCA CDx With Pfizer's Metastatic Breast Cancer Drug Jun 20, 2018 Merck KGaA Advancing Tepotinib in MET-Altered Cancer Subpopulations Premium Jun 18, 2018 Myriad Genetics Submits Supplementary PMA for BRACAnalysis CDx Jun 14, 2018 Janssen Plans Year-End Erdafitinib Filing Based on Phase II Data in FGFR-Mutated Bladder Cancer Premium May 1, 2018 Thermo Fisher Inks New Pharma Partnerships to Expand CDx Use of Oncomine NGS Test Jan 3, 2018 AstraZeneca, Myriad Ink Rx/Dx Collaboration for MyChoice HRD Plus Load More Breaking News At NSGC, Genetic Counselors Address Race-Based Medicine, Ways to Change New Products Posted to GenomeWeb: Becton Dickinson, Cosmos-ID, OncoDNA, More FDA Grants Emergency Use Authorization for Northeastern University SARS-CoV-2 Test FDA Revises SARS-CoV-2 Test Emergency Use Authorization Requirements to Account for Variants Geisinger Wins $5M NIH Grant to Develop Point-of-Care Genetic Diagnostic Tool Second Genome, Virginia Commonwealth University Partner on NASH Biomarker Discovery The Scan US Booster Eligibility Decision The US CDC director recommends that people at high risk of developing COVID-19 due to their jobs also be eligible for COVID-19 boosters, in addition to those 65 years old and older or with underlying medical conditions. Arizona Bill Before Judge The Arizona Daily Star reports that a judge weighing whether a new Arizona law restricting abortion due to genetic conditions is a ban or a restriction. Additional Genes Wales is rolling out new genetic testing service for cancer patients, according to BBC News. Science Papers Examine State of Human Genomic Research, Single-Cell Protein Quantification In Science this week: a number of editorials and policy reports discuss advances in human genomic research, and more.