tumor mutational burden 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. Diagnostics Firms, Lab Providers Form Genomic Profiling Coalition The new consortium is aiming to make comprehensive genomic profiling accessible to advanced cancer patients in the US, to help inform their treatment decisions. FDA Approves Foundation Medicine Liquid Biopsy Test as CDx for Lynparza The test will use a blood-based biopsy to detect patients with BRCA1, BRCA2, and/or ATM alterations in metastatic castration-resistant prostate cancer. Immunotherapy Response Prediction Improved by Baseline, On-Treatment Biomarker Combo Premium Stanford and Memorial Sloan Kettering researchers have developed a multi-modal and multi-timepoint biomarker approach to predict therapeutic benefit in lung cancer cases. Multi-Biomarker Strategies Show Promise in Improving Immunotherapy Response Prediction Premium In two studies at ESMO, researchers demonstrated the ability of combined biomarker approaches to predict the efficacy of immune checkpoint inhibitors. Jul 24, 2020 TMB Harmonization Effort Yields Calibration Method to Correct Inter-Assay Variation Premium Jul 21, 2020 NCCN's Updated Inherited Colorectal Cancer Risk Guidelines Features Gene-Specific Information Jun 22, 2020 Genomic Study Reveals Recurrent Cutaneous Melanoma Alterations, Male-Specific Mutations Jun 17, 2020 FDA Approves Merck's Keytruda, Foundation Medicine CDx for TMB-High Solid Tumors Jun 4, 2020 Tumor Mutational Burden in Blood May Predict Immunotherapy Response in Head, Neck Cancer Apr 30, 2020 TMB Harmonization Data Extends Concordance Findings, Tests Calibration Methods Apr 15, 2020 Glioma Hypermutation May Not Correspond to Checkpoint Immunotherapy Response, Study Suggests Apr 14, 2020 Merck Bid for Second Pan-Cancer Keytruda Indication Would Raise Tumor Mutation Burden to CDx Status Premium Apr 13, 2020 Pediatric Low-Grade Glioma Molecular and Clinical Analysis Defines Subtypes That Predict Outcome Mar 25, 2020 Prostate Cancer Cases in China Show Recurrent Alterations Distinct From Western Cohorts Feb 12, 2020 Exact Sciences Boosting Position in Cancer Dx Market Through M&A Premium Feb 5, 2020 Large-Scale Pan-Cancer Analysis Expands Set of Alterations Disrupting Key Genes, Pathways Jan 14, 2020 Immunotherapy Response Prediction Improves With TMB Correction, Other Markers Premium Dec 18, 2019 DNAnexus PrecisionFDA Platform Expansion Will Add Support for Multi-Omics Data, Interactive Review Premium Dec 17, 2019 NeoGenomics Focused on Companion Diagnostics, NGS in 2020 Premium Nov 19, 2019 Despite FDA Clearance for NantHealth Test, Benefits of TMB Biomarker Unclear Premium Nov 19, 2019 Paragon Genomics Discusses New Gene Fusion Detection Method, Cystic Fibrosis Panel Premium Nov 12, 2019 AMP Attendees Reflect on Uptake of Tumor Mutational Burden Amid Validation, Utility Questions Premium Sep 23, 2019 PGDx Shares New MSI Data, Provides Update on FDA Bid for Pan-Cancer IVDs Premium Sep 10, 2019 European Labs Continue to Validate, Implement TMB, Facing Down Cutoff Discordance Concerns Premium Load More Breaking News Novacyt 2020 Revenues Surge on Strong Demand for SARS-CoV-2 Testing Products Leidos Wins CDC Bioinformatics Contract Worth up to $13M Thermo Fisher Scientific Next-Generation SARS-CoV-2 PCR Test Nabs CE-IVD Mark Cytosine Base Editor Enables Genome-Wide Genetic Function Screening G42 Healthcare, Seegene to Offer Mobile Molecular Diagnostic Labs in Middle East, North Africa JP Morgan, Cowen Initiate Coverage of Singular Genomics Systems The Scan Renewed Gain-of-Function Worries The New York Times writes that the pandemic is renewing concerns about gain-of-function research. Who's Getting the Patents? A trio of researchers has analyzed gender trends in biomedical patents issued between 1976 and 2010 in the US, New Scientist reports. Other Uses CBS Sunday Morning looks at how mRNA vaccine technology could be applied beyond SARS-CoV-2. PLOS Papers Present Analysis of Cervicovaginal Microbiome, Glycosylation in Model Archaea, More In PLOS this week: functional potential of the cervicovaginal microbiome, glycosylation patterns in model archaea, and more.