pembrolizumab 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. Somatic Mutations in Lung Cancer Patients With HLA Supertype B44 Influence Immunotherapy Response The B44 supertype is associated with improved survival in melanoma patients treated with immunotherapy, but less so in NSCLC patients, due to mutational differences. FDA Approves Merck's Keytruda, Agilent CDx in PD-L1-High Triple-Negative Breast Cancer The agency approved Agilent/Dako's PD-L1 IHC test for identifying TNBC patients who are most likely to respond to Keytruda and chemo. 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 Aug 16, 2019 Foundation Medicine to Seek FDA Approval for FoundationOne as CDx to Genentech's Rozlytrek Aug 8, 2019 Guardant Health Preps Pan-Cancer FDA Bid, Highlights New MSI Validation Data Premium Load More Breaking News Singular Genomics Systems Reports No Revenues, Increased Net Loss for Q2 Burning Rock Biotech, Impact Therapeutics Partner on CDx for PARP Inhibitor Senaparib Gene Editing Analysis Firm SeQure Dx Closes $17.5M Series A Funding Round Resolve Biosciences, Zeiss Partner to Enhance Spatial Biology Imaging Tech EliTechGroup Obtains CE Mark for Saliva Use With SARS-CoV-2 Test Waters Q2 Revenues Up 31 Percent The Scan And Back The New York Times reports that missing SARS-CoV-2 genome sequences are back in a different database. Lacks Family Hires Attorney A lawyer for the family of Henrietta Lacks plans to seek compensation from pharmaceutical companies that have used her cancer cells in product development, the Baltimore Sun reports. For the Unknown The Associated Press reports that family members are calling on the US military to use new DNA analysis techniques to identify unknown sailors and Marines who were on the USS Arizona. PLOS Papers on Congenital Heart Disease, COVID-19 Infection Host MicroRNAs, Multiple Malformation Mutations In PLOS this week: new genes linked to congenital heart disease, microRNAs with altered expression in COVID-19, and more.