Reference Samples to Compare Next-Generation Sequencing Test Performance for Oncology Therapeutics and Diagnostics.

Objectives: Diversity of laboratory-developed tests (LDTs) using next-generation sequencing (NGS) raises concerns about their accuracy for selection of targeted therapies. A working group developed a pilot study of traceable reference samples to measure NGS LDT performance among a cohort of clinical laboratories.

Methods: Human cell lines were engineered via CRISPR/Cas9 and prepared as formalin-fixed, paraffin-embedded cell pellets ("wet" samples) to assess the entire NGS test cycle.

Molecular Diagnosis of Coronavirus Disease 2019.

Objectives: To review molecular diagnostics for coronavirus disease 2019. The world is in the midst of a coronavirus disease 2019 pandemic. Containing the spread of the severe acute respiratory distress coronavirus is critical.

Economics of Coding, Coverage, and Reimbursement for Molecular Diagnostics.

This editorial highlights the article from the Association for Molecular Pathology's Economic Affairs Committee that appears in this issue.

Renewed Commitments to Key Partners.

This Editorial highlights the updates to the publication frequency, member benefits, and societal oversight of The Journal of Molecular Diagnostics beginning in January 2020.

The Journal of Molecular Diagnostics: 20 Years Defining Professional Practice.

This editorial highlights 20 years of JMD defining professional practice.

Integration Standardization and Diagnostics Oversight of Laboratory Testing.

This editorial highlights the article by Schreier et al that emphasizes on reforming the process for regulating laboratory developed testing.

Expanding the Scope of The Journal of Molecular Diagnostics to the Informatics Subdivision of the Association for Molecular Pathology.

This editorial describes the expanded scope of The Journal of Molecular Diagnostics, to include informatics-based articles.

Translating Risk of Consumer-Initiated Genetic Testing.

This editorial highlights the article by Bick and colleagues that proposes a framework for evaluating elective genomic testing.

Keeping Practice Recommendations in Step with Advancing Knowledge.

This editorial comments on the updated molecular testing guideline for lung cancer patients.

Navigating the Peer Review Process.

This editorial provides insights and guidelines for publishing in The Journal of Molecular Diagnostics.

Anticoagulation manager: development of a clinical decision support mobile application for management of anticoagulants.

Patients with certain clotting disorders or conditions have a greater risk of developing arterial or venous clots and downstream embolisms, strokes, and arterial insufficiency. These patients need prescription anticoagulant drugs to reduce the possibility of clot formation. However, historically, the clinical decision making workflow in determining the correct type and dosage of anticoagulant(s) is part science and part art.

Guidelines for Colorectal Cancer Testing: Evidence-Based Practice Recommendations.

This Editorial provides readers additional insight on the colorectal guideline appearing in this issue.

Diagnostic Quality Assurance Pilot: A Model to Demonstrate Comparative Laboratory Test Performance with an Oncology Companion Diagnostic Assay.

This Editorial highlights a model demonstrating laboratory test performance with a companion diagnostic assay.

Evaluation of Diverse Health Professionals' Learning Experience in a Continuing Education Activity for Quality Practices in Molecular Genetic Testing.

Objective: This study was conducted to evaluate the responses of 3,265 health professionals who took a continuing education (CE) activity during June 2009 - April 2012 for a comprehensive set of good laboratory practice recommendations for molecular genetic testing.

Design: Participants completed an evaluation questionnaire as part of the CE activity. Responses were summarized to assess the participants' learning outcomes and commitment to applying the knowledge gained.

Thymidylate synthase genotype-directed chemotherapy for patients with gastric and gastroesophageal junction cancers.

Background: Retrospective studies indicate associations between TSER (thymidylate synthase enhancer region) genotypes and clinical outcomes in patients receiving 5-FU based chemotherapy, but well-controlled prospective validation has been lacking.

Methods: In this phase II study (NCT00515216 registered through ClinicalTrials.gov, http://clinicaltrials.