Genomics: Clinical Implementation

This channel includes news headlines and educational resources regarding the clinical implementation of genomics assays, including development, validation, quality control, standardization, and the practical and commercial considerations for labs adopting these tests.

Oncocyte AACR Data Expands Potential Applications for Immunotherapy Response Predictor

The firm presented evidence that its DetermaIO gene expression test can help predict which bladder cancer patients are likely to respond to immune checkpoint inhibitors.

Genetron Health Updates Data from Prospective Liquid Biopsy Liver Cancer Screening Study

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The results represent a significant improvement over currently used screening tools and are spurring renewed LDT commercialization and regulatory submission efforts.

Bionano Genomics Outlines Strategy for Clinical Adoption of Optical Genome Mapping

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The company is also working on a new Saphyr system that will have 14 times higher throughput than the current one, which can analyze 5,000 human genomes per year.

New AMP Survey Reports Insufficient Reimbursement for Analysis, Interpretation of MDx Test Results

The survey found analysis, interpretation, and reporting requirements can take more than six hours per test but that reimbursement for tests doesn't account for this work.

GeneFirst Aims to Prove Clinical Feasibility for ATOM-Seq Colorectal Cancer Detection Test

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The company is collaborating with the University of Leeds under a new grant, aiming to collect prospective validation and economic data that could support clinical adoption.

Feb 24, 2021

ACMG Lobbying State Legislatures on Genetic Counselors' Scope of Practice Draws Criticism

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Feb 23, 2021

AMP Survey Finds Significant Decline in Molecular Cancer Testing Due to COVID-19 Pandemic

Feb 23, 2021

German Medical Center to Report Polygenic Risk Scores as Part of Clinical Whole-Genome Testing

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Feb 18, 2021

Rady Children’s Institute for Genomic Medicine Gets NY State Approval for Sequencing Tests

Feb 05, 2021

Guardant Health Turns to Tumor Tissue Sequencing to Broaden Offering

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Jan 29, 2021

Stanford Launches Clinical Whole-Genome Sequencing for Inherited Cardiovascular Testing

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Jan 20, 2021

CMS Finalizes Blood-Based Colon Cancer Screening NCD with Non-Coverage for Epi ProColon

Jan 11, 2021

Multi-Cancer Molecular Screening Assays Primed for Clinical Implementation in 2021

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Jan 11, 2021

Grail Inks Deals With Amgen, AstraZeneca, Bristol Myers Squibb for MRD Test Development

Jan 11, 2021

Helix Obtains FDA Authorization for Exome Sequencing Platform, Alzheimer's Disease Risk Test

Jan 05, 2021

New York Study Aims to Assess Utility of Clinical Whole-Genome Sequencing Across Diseases

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Dec 18, 2020

UK Launches Public-Private iDx-Lung Consortium to Improve Early Detection of Lung Cancers

Dec 15, 2020

University of Chicago Program Aims to Improve Knowledge Transfer for PGx Testing

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Dec 03, 2020

Aetna Updates Noninvasive Prenatal Testing Coverage Policy to Include All Pregnancies

Dec 03, 2020

Illumina, New York Healthcare Providers, NYGC Partner on Clinical Whole-Genome Sequencing

Dec 02, 2020

China NMPA Approves Illumina NextSeq 550Dx Sequencer for Genetic Testing and Diagnosis

Nov 25, 2020

European Consortium Seeks to Develop Liquid Biopsy Test for Prostate, Testicular Cancer

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Nov 17, 2020

Diagnostics Firms, Lab Providers Form Genomic Profiling Coalition

Nov 16, 2020

Myriad Genetics Bets Fetal DNA Enrichment Method Will Further Increase Uptake of NIPS Test

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Nov 11, 2020

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Genomics: Clinical Implementation

Oncocyte AACR Data Expands Potential Applications for Immunotherapy Response Predictor

Genetron Health Updates Data from Prospective Liquid Biopsy Liver Cancer Screening Study

Bionano Genomics Outlines Strategy for Clinical Adoption of Optical Genome Mapping

New AMP Survey Reports Insufficient Reimbursement for Analysis, Interpretation of MDx Test Results

GeneFirst Aims to Prove Clinical Feasibility for ATOM-Seq Colorectal Cancer Detection Test

ACMG Lobbying State Legislatures on Genetic Counselors' Scope of Practice Draws Criticism

AMP Survey Finds Significant Decline in Molecular Cancer Testing Due to COVID-19 Pandemic

German Medical Center to Report Polygenic Risk Scores as Part of Clinical Whole-Genome Testing

Rady Children’s Institute for Genomic Medicine Gets NY State Approval for Sequencing Tests

Guardant Health Turns to Tumor Tissue Sequencing to Broaden Offering

Stanford Launches Clinical Whole-Genome Sequencing for Inherited Cardiovascular Testing

CMS Finalizes Blood-Based Colon Cancer Screening NCD with Non-Coverage for Epi ProColon

Multi-Cancer Molecular Screening Assays Primed for Clinical Implementation in 2021

Grail Inks Deals With Amgen, AstraZeneca, Bristol Myers Squibb for MRD Test Development

Helix Obtains FDA Authorization for Exome Sequencing Platform, Alzheimer's Disease Risk Test

New York Study Aims to Assess Utility of Clinical Whole-Genome Sequencing Across Diseases

UK Launches Public-Private iDx-Lung Consortium to Improve Early Detection of Lung Cancers

University of Chicago Program Aims to Improve Knowledge Transfer for PGx Testing

Aetna Updates Noninvasive Prenatal Testing Coverage Policy to Include All Pregnancies

Illumina, New York Healthcare Providers, NYGC Partner on Clinical Whole-Genome Sequencing

China NMPA Approves Illumina NextSeq 550Dx Sequencer for Genetic Testing and Diagnosis

European Consortium Seeks to Develop Liquid Biopsy Test for Prostate, Testicular Cancer

Diagnostics Firms, Lab Providers Form Genomic Profiling Coalition

Myriad Genetics Bets Fetal DNA Enrichment Method Will Further Increase Uptake of NIPS Test

Adaptive Biotechnologies, GlaxoSmithKline Collaborate on MRD Testing