CMS Banner Year for Blood-Based Cancer Screening in 2021, but Reimbursement and Utility Hurdles Loom Premium New companies claimed stakes during the year, established firms solidified their plans and data, and Grail launched the first genomic multi-cancer early detection test. CMS Repeals Rule Aimed at Expediting Medicare Coverage for FDA Breakthrough Devices The rule would have granted quicker Medicare coverage for up to four years for tests that had received breakthrough device designation from the FDA. Palmetto Finalizes Medicare Coverage for MRD Cancer Testing To receive coverage, the patient must have a personal history of cancer where the type and staging are within the intended use of the test. Adaptive Biotechnologies' T-Cell Assay Plans Boosted by Medicare Nod for COVID Test Premium The company has slightly extended its timeline for launching a Lyme disease test to focus on marketing its COVID assay for immunocompromised individuals. Labs Ask Medicare Contractor to Refine Coverage Policy for 'Comprehensive' NGS Cancer Testing Premium National Government Services' proposal to broaden coverage of large sequencing panels for solid tumor patients is positive but may need clarification to ensure appropriate patient care. Jul 21, 2021 Biocept HER2 Assay Gains Coverage Under Medicare Local Coverage Determination for CTC Tests Jul 16, 2021 US House Appropriations Committee Seeks 15 Percent NIH Funding Increase for Fiscal 2022 Jun 4, 2021 Veracyte Bladder Cancer Test Receives Medicare Coverage May 28, 2021 Postponed CMS Proposal Would Remove Unspecified Cancer Dx Codes, Impacting Test Access Premium May 21, 2021 Palmetto Releases Draft LCD for Prostate Cancer Risk Stratification Tests Apr 22, 2021 Medicare Administrative Contractor Palmetto Finalizes Coverage of Molecular Testing for Organ Transplant Rejection Mar 31, 2021 Biocept Prepares for First FDA Foray With CSF Liquid Biopsy Brain Metastases Assay Premium Mar 2, 2021 PreludeDx DCIS Breast Cancer Test Helps Determine Radiation Therapy Benefits, Reduce Overtreatment Premium Jan 26, 2021 Genomind Receives Medicare Coverage for Pharmacogenetics Test Jan 20, 2021 CMS Finalizes Blood-Based Colon Cancer Screening NCD with Non-Coverage for Epi ProColon Dec 22, 2020 Congress Approves 3 Percent Increase in NIH Budget for Fiscal 2021 Dec 10, 2020 Lucence Obtains CLIA Certification for Palo Alto Lab Dec 3, 2020 Local Coverage Determinations Roundup: Castle Bio Dec 2, 2020 Diaceutics, Alva10 Gathering Evidence Base for Improving PD-L1 Test Reimbursement Premium Nov 19, 2020 CGS Administrators Aligns Medicare Coverage for CareDx AlloSure Tests Nov 13, 2020 Clinical Genomics Nabs Medicare Coverage for Colorectal Cancer Test as Novitas Revises LCD Nov 6, 2020 Medicare Administrative Contractor CGS Aligns Coverage for Melanoma Risk Stratification Tests Oct 28, 2020 Strata Oncology Receives Medicare Coverage for NGS Test Oct 22, 2020 Local Coverage Determinations Roundup: CareDx, Castle Bio, Decipher Biosciences Oct 19, 2020 CMS Colon Cancer Screening Memo Bodes Well for Assays in Development; Denies Epi ProColon Load More Breaking News Centogene Strikes Rare Disease Target Discovery Deal With Insilico Medicine Dilated Cardiomyopathy Gene Mutations Point to Possible Therapeutic Strategy Ginkgo Bioworks Acquires Massachusetts COVID-19 Testing Firm Mainz Biomed Taps DCN Dx to Aid European Study of Enhanced ColoAlert Assay Parse Biosciences Partners With Research Instruments for Southeast Asia Distribution Thermo Fisher, Oncocyte Ink Development, Comarketing Deal for Cancer IVDs The Scan And a Fourth? A fourth dose of the Pfizer-BioNTech SARS-CoV-2 vaccine in an Israeli study increased antibody levels but did not prevent Omicron variant infections, according to the Financial Times. For Better Science Software A virtual institute funded by former Google CEO Eric Schmidt's philanthropy aims to lure software engineers to academia, Science reports. Recommendation Explanations The New York Times writes that the US Centers for Disease Control and Prevention is straining to both make and explain decisions based on limited information. Genome Research Papers on De Novo Mutation Rates, Polyploid Genotyping, Oncogene Epigenomic Translocation In Genome Research this week: de novo mutations rates in hemoglobin subunits, analysis of variant calling methods for polyploid plants, and more.