2024
Strength of evidence underlying the CMS-FDA parallel review of comprehensive genomic profiling tests in the cancer setting
Stackland S, Schnabel D, Dinan M, Presley C, Gross C. Strength of evidence underlying the CMS-FDA parallel review of comprehensive genomic profiling tests in the cancer setting. Journal Of The National Cancer Institute 2024, djae196. PMID: 39288939, DOI: 10.1093/jnci/djae196.Peer-Reviewed Original ResearchComprehensive genomic profilingComprehensive genomic profiling testCenter for Medical Technology PolicyClinical careClinical outcomesDiagnostic testsAssessed clinical outcomesOutcomes of patientsStrength of evidenceCourse of clinical careEfficacy of diagnostic testsNovel diagnostic testsPeer-reviewed literatureGenomic profiling testsFoundationOne CDxGenomic testingSolid tumorsStudy designGenomic alterationsGenomic profilingF1CDxCancer settingClinical utilityCancer typesCompare groups
2019
Proposal for Value-Based, Tiered Reimbursement for Tumor Biomarker Tests to Promote Innovation and Evidence Generation.
Dinan MA, Lyman GH, Schilsky RL, Hayes DF. Proposal for Value-Based, Tiered Reimbursement for Tumor Biomarker Tests to Promote Innovation and Evidence Generation. JCO Precision Oncology 2019, 3: 1-10. PMID: 35100733, DOI: 10.1200/po.19.00210.Peer-Reviewed Original ResearchTumor biomarker testsClinical utilityBiomarker testsFormal cost-effectiveness analysisHigh-level evidenceLow-level evidenceHealth care dollarsPrecision cancer careCost-effectiveness analysisCancer careEffective therapyCancer precision medicineTreatment decisionsTreatment selectionIneffective treatmentPoor reimbursement