Companion Diagnostics News on companion diagnostics and drug/test co-development. 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. Japanese Health Ministry Clears Thermo Fisher Scientific Oncomine Assay as CDx for Lung Cancer Drug The Oncomine Dx Target Test can now be used to identify patients with RET-fusion positive NSCLC who may be treated with Eli Lilly's selpercatinib. Illumina, Merck Partner to Advance Homologous Recombination Deficiency CDx, Research Assay Under the terms of the deal, Illumina will develop a new HRD CDx for the EU and UK markets and a research-use only HRD assay that will be add-on content for its TSO 500 panel. Thermo Fisher Scientific, AstraZeneca Team up to Develop CDx for Targeted Drugs The next-generation sequencing based companion diagnostics will be paired with targeted therapies that are being developed for several diseases. FDA Clears Thermo Fisher Scientific Oncomine Assay as CDx for Bile Duct Cancer Drug The Oncomine Dx Target Test can now be used to identify patients with IDH1-mutated cholangiocarcinoma who may be candidates for ivosidenib. Aug 19, 2021 Amoy Diagnostics, Amgen Partner on Lung Cancer CDx Development for Lumakras in Japan Aug 17, 2021 Amoy Diagnostics CDx Gets Japanese Approval to ID NSCLC Patients Eligible for Tepmetko Aug 9, 2021 Qiagen, OncXerna Therapeutics Ink Companion Dx Development, Technology-Licensing Deal Aug 5, 2021 State-Regulated Illinois Health Plans Subject to Biomarker Test Coverage Mandate Starting 2022 Premium Aug 5, 2021 Promega, Henlius to Develop Microsatellite Instability CDx for Cancer Drug Aug 3, 2021 Burning Rock Biotech, Impact Therapeutics Partner on CDx for PARP Inhibitor Senaparib Jul 16, 2021 FDA Approves Foundation Medicine's Liquid Biopsy Test as CDx for Novartis' Tabrecta in NSCLC Jul 1, 2021 FDA Approves FoundationOne CDx for Takeda's ALK-Inhibitor Jul 1, 2021 Qiagen, Sysmex Form Global Companion Diagnostic Development Pact Jun 30, 2021 AmoyDx PCR Panel Receives Japanese Approval as CDx for Non-Small Cell Lung Cancer Therapies Jun 15, 2021 Caris Life Sciences, Elevation Oncology Team on Targeted Drug Development May 28, 2021 FDA Approves Bile Duct Cancer Drug from Helsinn, BridgeBio Pharma With Foundation Medicine CDx May 28, 2021 FDA Approves Amgen's Lumakras for NSCLC Alongside Companion Tests From Guardant Health, Qiagen May 25, 2021 Qiagen, Mirati Therapeutics Partner to Develop KRAS Companion Test for NSCLC Drug May 13, 2021 LGC SeraCare Joins Diaceutics DXRX Network for Precision Medicine Diagnostics Apr 29, 2021 Burning Rock Biotech, Abbisko Therapeutics Ink CDx Partnership for ABSK091 Apr 22, 2021 Illumina, Kartos Therapeutics Partner to Develop TP53 Companion Diagnostic Apr 6, 2021 Roche to Use Oncimmune Infectious Disease Panel in COVID-19 Drug Trial Mar 30, 2021 MapKure, Personalis Partner to Screen Patients for BRAF Inhibitor Trial Mar 12, 2021 Prometheus Biosciences Prices Upsized $190M IPO Load More Breaking News Beckman Coulter, Invitae Partner to Develop NGS Library Prep Applications Sick Infants Profiled with WGS See Better Diagnosis, More Care Changes UC Santa Cruz Center for Live Cell Genomics Wins $13.5M NIH Grant Genetron Health, Impact Therapeutics Partner for Anti-Cancer Drug, CDx Development Canaccord Genuity Initiates Coverage of Pacific Biosciences With Buy Rating Alternative Genetic Counseling Approach Leads to Higher Patient Satisfaction, Study Suggests The Scan Highly Similar Researchers have uncovered bat viruses that are highly similar to SARS-CoV-2, according to Nature News. Gain of Oversight According to the Wall Street Journal, the Biden Administration is considering greater oversight of gain-of-function research. Lasker for mRNA Vaccine Work The Scientist reports that researchers whose work enabled the development of mRNA-based vaccines are among this year's Lasker Award winners PLOS Papers on Causal Variant Mapping, Ancient Salmonella, ALK Fusion Test for NSCLC In PLOS this week: MsCAVIAR approach to map causal variants, analysis of ancient Salmonella, and more.