Merck Lynparza Benefit in Early BRCA-Mutated Breast Cancer Reignites Universal Genetic Testing Discussion Premium The OlympiA trial showed a disease-free survival benefit with adjuvant PARP inhibitor therapy for early-stage, BRCA1/2-mutated, HER2-negative breast cancer patients. M2Gen Lands New Private Investment, Inks Research Deal with Merck Bioinformatics firm M2Gen will provide Merck with deidentified clinical and genomics data to aid in oncology drug discovery and development. MSK Study Underscores Need to Validate Cancer-Specific Tumor Mutational Burden Cutoffs Premium A TMB-high cutoff of 10 mutations per megabase doesn't predict immunotherapy responses universally well across cancer types, according to a paper published in JAMA Oncology. Illumina CEO Discusses Pan-Cancer IVD Assay, CDx Collaborations at JP Morgan The firm also provided preliminary revenues of $950 million for Q4 and reinstated guidance of $3.79 billion to $3.88 billion for 2021. Nonprofit Friends of Cancer Research Launches Public-Private HRD Harmonization Project The consortium aims to harmonize the use of homologous recombination deficiency as a biomarker to guide certain treatment types in cancer patients. Nov 13, 2020 FDA Approves Merck's Keytruda, Agilent CDx in PD-L1-High Triple-Negative Breast Cancer Nov 9, 2020 FDA Approves Foundation Medicine Liquid Biopsy Test as CDx for Lynparza Jul 24, 2020 TMB Harmonization Effort Yields Calibration Method to Correct Inter-Assay Variation Premium Jun 18, 2020 Promega Maintains Microsatellite Instability IVD Plans Amid Evolving Cancer Test Landscape Premium Jun 17, 2020 FDA Approves Merck's Keytruda, Foundation Medicine CDx for TMB-High Solid Tumors May 20, 2020 FDA Approves Lynparza With Myriad, Foundation Med CDx Tests in HRR-Mutated Prostate Cancer May 11, 2020 FDA Approves Lynparza/Avastin With Myriad Genetics CDx for Platinum-Sensitive Ovarian Cancer Apr 27, 2020 Merck, ISB Collaborating on COVID-19 Drug, Vaccine Target Discovery Apr 14, 2020 Merck Bid for Second Pan-Cancer Keytruda Indication Would Raise Tumor Mutation Burden to CDx Status Premium Mar 30, 2020 Myriad Genetics Seeks Japan Approval for Advanced Pancreatic, Prostate Cancer Companion Diagnostic Mar 5, 2020 Genedata Moves Into R&D for Nonprofits, Adds Digital Pathology Support Premium Feb 11, 2020 Myriad Files sPMA With FDA for Test to ID Best Responders to Lynparza, Avastin Combination Jan 21, 2020 Myriad Genetics Files for FDA Approval of BRACAnalysis CDx for Lynparza in Prostate Cancer Dec 30, 2019 FDA Approves AstraZeneca's Lynparza, Myriad Genetics' CDx for BRCA-Positive Pancreatic Cancer Dec 12, 2019 Immunotherapy Regimens Yield Contrasting Results in Early Triple Negative Breast Cancer Premium Dec 4, 2019 PGDx Gets IDE For Tissue NGS Test in Merck Immunotherapy Trial Nov 6, 2019 Merck, Promega Collaborate to Develop MSI CDx for Keytruda Aug 7, 2019 Myriad Genetics Seeking Additional FDA Approval for BRACAnalysis CDx Jul 1, 2019 FDA Approves Foundation Medicine CDx Test for Lynparza Jul 1, 2019 Merck KGaA to Distribute RevoluGen's High Molecular Weight DNA Extraction Product Load More Breaking News Enzo Biochem, CLX Health Partner to Support COVID-19 Testing for International Travel Type 1 Diabetes GWAS, Fine-Mapping Leads to New Genetic Loci, Potential Drug Targets LSU Health Sciences Center Wins $2.4M to Lead SARS-CoV-2 Variant Sequencing Program NanoString Technologies, Parker Institute for Cancer Immunotherapy Partner on Cell Therapy Project BGI Americas Collaborating With Champions Oncology on Proteomic Cancer Research Personal Genome Diagnostics Inks Cancer Genomic Profiling Deal with Duke University Health System The Scan Missed Early Cases A retrospective analysis of blood samples suggests early SARS-CoV-2 infections may have been missed in the US, the New York Times reports. Limited Journal Editor Diversity A survey finds low diversity among scientific and medical journal editors, according to The Scientist. How Much of a Threat? Science writes that need for a provision aimed at shoring up genomic data security within a new US bill is being questioned. PNAS Papers on Historic Helicobacter Spread, Brain Development, C. difficile RNAs In PNAS this week: Helicobacter genetic diversity gives insight into human migrations, gene expression patterns of brain development, and more.