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Publication Topic: Diagnostics

White Paper | Innovative Validation And Regulatory Processes For Companion Diagnostic Tests For Rare Biomarkers Or Indications

Discussion Document | Considerations For Developing Reference Data Sets For Digital Pathology Biomarkers

2024 Scientific Report

RFI | Enhancing Adoption of Innovative Clinical Trial Approaches

RFI | Scientific Challenges and Opportunities To Advance the Development of Individualized Cellular and Gene Therapies

Proposed Rule | Medical Devices; Laboratory Developed Tests

Public Comment | Cancer Clinical Trial Eligibility Criteria: Brain Metastases

Poster | 2018 SITC Annual Meeting | In Silico Assessment of Variation in TMB Quantification Across Diagnostic Platforms: Phase 1 of the Friends of Cancer Research Harmonization Project

Poster | 2019 ASCO Annual Meeting | TMB Standardization by Alignment to Reference Standards

Poster | 2022 AMP Annual Meeting | Assessing Variability Across HRD Assays: Findings from the Friends’ HRD Harmonization Project