pembrolizumab FDA Approves Foundation Medicine Test as CDx for Merck's Keytruda to Identify MSI-H Solid Tumors The FoundationOne CDx test can now be used as a companion diagnostic for the drug to identify patients with solid tumors that have high microsatellite instability. UK Researchers Show Cytotoxic T-Cell Level Predicts Melanoma Immunotherapy Response A Science Immunology paper details how patients with more cytotoxic effector T cells in peripheral blood at baseline respond better to checkpoint inhibitors. Breast Cancer Immunotherapy Response Markers Emerge From Single-Cell Sequencing Study Researchers identified several pre-treatment markers that correlated with T-cell expansion and could be predictive of response to a PD1 inhibitor. Cofactor Genomics Cements Clinical Diagnostic Plans as Immunotherapy Prediction Data Builds Premium The firm highlighted a new study exploring immune-related gene expression in ovarian cancer and gave an update on its lead diagnostic candidate for head and neck tumors. 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. Nov 16, 2020 Somatic Mutations in Lung Cancer Patients With HLA Supertype B44 Influence Immunotherapy Response Nov 13, 2020 FDA Approves Merck's Keytruda, Agilent CDx in PD-L1-High Triple-Negative Breast Cancer Oct 7, 2020 Immunotherapy Response Prediction Improved by Baseline, On-Treatment Biomarker Combo Premium Aug 3, 2020 Natera's Signatera ctDNA Test Shows Immunotherapy Response Prediction Capability in Advanced Cancer Jun 29, 2020 Creatv MicroTech Aims to Detect Patient Immune Cells for Cancer Drug Response Prediction Premium Jun 18, 2020 Promega Maintains Microsatellite Instability IVD Plans Amid Evolving Cancer Test Landscape Premium Jun 18, 2020 Protypia, Lilly Show Mass Spec PD-L1 Measurements Vary Widely From IHC Results Premium Jun 17, 2020 FDA Approves Merck's Keytruda, Foundation Medicine CDx for TMB-High Solid Tumors Jun 9, 2020 Promega Nabs CE Mark for Microsatellite Instability IVD May 11, 2020 Decipher Bladder Cancer Test Determines Molecular Subtype Most Likely to Respond to Keytruda Premium Apr 28, 2020 New Iteration of AACR's Project GENIE Focuses on Real-World Outcomes to Enhance Precision Oncology Premium Apr 14, 2020 Merck Bid for Second Pan-Cancer Keytruda Indication Would Raise Tumor Mutation Burden to CDx Status Premium Feb 19, 2020 Cancer, Pathology Organizations Developing Clinical Guidelines for MMR, MSI Testing Jan 15, 2020 Presence of B Cells in Tumors Associated With Favorable Immunotherapy Outcomes Jan 14, 2020 Immunotherapy Response Prediction Improves With TMB Correction, Other Markers Premium 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 19, 2019 Despite FDA Clearance for NantHealth Test, Benefits of TMB Biomarker Unclear Premium Nov 6, 2019 Merck, Promega Collaborate to Develop MSI CDx for Keytruda Sep 23, 2019 PGDx Shares New MSI Data, Provides Update on FDA Bid for Pan-Cancer IVDs Premium Load More Breaking News Guardant Health Files Motions to Dismiss, Change Venue in Illumina Patent Lawsuit In Brief This Week: SQI Diagnostics, T2 Biosystems, Enhanc3D, QuidelOrtho, More Illumina, Precision Health Research Singapore Partner for 100K Genomes Population Study 23andMe Fiscal Q4 Revenues Increase 14 Percent Local Coverage Determinations Roundup: Castle Bio, SkylineDx Ancient Genome Sequence Provides Look at Ancestry for Individual Who Perished at Pompeii The Scan Billion-Dollar Diversity Initiative The Howard Hughes Medical Institute is now accepting applications for its new $1.5 billion initiative to boost the diversity of the scientific workforce. Biotech Co-Founder Arrested A co-founder of a Los Angeles-based biotech company has been arrested in connection with a murder-for-hire scheme, according to Endpoint News. Return of the Tasmanian Tiger The Washington Post reports that a team in Australia is working to bring the thylacine back from extinction. Nature Papers on Genome of Individual From Pompeii, CircRNA Study Best Practices, More In Nature this week: first sequenced genome of a person from Pompeii, best practice guidelines for circRNA studies, and more.