Development of a somatic variant registry in a National Cancer Center: towards Molecular Real World Data preparedness

Article Computer Science, Information Systems

Introducing HL7 FHIR Genomics Operations: a developer-friendly approach to genomics-EHR integration

Robert H. Dolin et al.

Summary: By encapsulating the complexity of molecular data, FHIR Genomics Operations provide a standardized interface for applications, enabling clinicians to formulate individualized clinical management strategies.

JOURNAL OF THE AMERICAN MEDICAL INFORMATICS ASSOCIATION (2023)

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Article Pharmacology & Pharmacy

Understanding Use of Real-World Data and Real-World Evidence to Support Regulatory Decisions on Medical Product Effectiveness

Nirosha Mahendraratnam et al.

Summary: Research has shown that RWE has been used to support the regulatory effectiveness of oncology and rare disease treatments, but there is potential for expanding its use to other therapeutic areas for a more patient-centered approach.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2022)

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Article Oncology

Co-occurring genomic alterations and immunotherapy efficacy in NSCLC

Fan Zhang et al.

Summary: This study establishes an oncogene-centric molecular classification paradigm in non-small cell lung cancer (NSCLC) and identifies the impact of co-occurring mutations on the efficacy of immune checkpoint inhibitors. The study emphasizes the importance of considering interactions between mutations when developing prediction algorithms for cancer therapeutics.

NPJ PRECISION ONCOLOGY (2022)

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Article Pathology

Evaluation of the TruSight Oncology 500 Assay for Routine Clinical Testing of Tumor Mutational Burden and Clinical Utility for Predicting Response to Pembrolizumab

Bo Wei et al.

Summary: This study evaluated the clinical utility of TSO500, a gene testing method, for determining the eligibility of patients for pembrolizumab treatment. The results showed a high concordance between TSO500 and two reference methods, indicating that TSO500 can effectively predict the response to pembrolizumab in patients with high TMB levels.

JOURNAL OF MOLECULAR DIAGNOSTICS (2022)

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Article Oncology

Implementation of a Molecular Tumor Registry to Support the Adoption of Precision Oncology Within an Academic Medical Center: The Duke University Experience

Michelle F. Green et al.

Summary: Comprehensive genomic profiling is essential in oncology care but can be challenging for oncologists to interpret. The Molecular Registry of Tumors (MRT) and Molecular Tumor Board (MTB) provide a solution by aggregating genomic data and facilitating targeted therapy selection. Through MRT, therapeutic sensitivity, resistance alterations, and potential germline implications can be identified, ultimately improving precision cancer medicine programs.

JCO PRECISION ONCOLOGY (2021)

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Article Oncology