Companion Diagnostics News on companion diagnostics and drug/test co-development. EU IVDR Implementation Woes Could Severely Limit Cancer Companion Test, Precision Therapy Access Premium The EC has stuck with its timeline to implement the new regulations in eight months, raising concerns for cancer patients' ability to receive biomarker testing and treatments. 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. Aug 26, 2021 FDA Clears Thermo Fisher Scientific Oncomine Assay as CDx for Bile Duct Cancer Drug 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 Load More Breaking News Exome Sequencing of UK Biobank Participants Highlights Natural Variation, Gene Function Cystic Fibrosis Sinus Infections Involve Microbes With Shifting Evolution Patterns Molecular Assemblies Wins $256K NIH Phase I SBIR Grant to Develop Enzymatic DNA Synthesis Vibrent Health, VCU Partner to Offer Twin Research Platform Castle Biosciences Acquires Cernostics for up to $80M Princess Margaret Cancer Centre, Inivata Partner on Clinical Liquid Biopsy Studies The Scan Could Mix It Up The US Food and Drug Administration is considering a plan that would allow for the mixing-and-matching of SARS-CoV-2 vaccines and boosters, the New York Times says. Closest to the Dog New Scientist reports that extinct Japanese wolf appears to be the closest known wild relative of dogs. Offer to Come Back The Knoxville News Sentinel reports that the University of Tennessee is offering Anming Hu, a professor who was acquitted of charges that he hid ties to China, his position back. PNAS Papers on Myeloid Differentiation MicroRNAs, Urinary Exosomes, Maize Domestication In PNAS this week: role of microRNAs in myeloid differentiation, exosomes in urine, and more.