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.

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

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Backed by large public companies and growing prospective data, the first molecular blood tests to screen for multiple cancers are approaching commercialization.

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

The company aims to use the methylation technology from its multi-cancer screening assay to detect minimal residual disease in early-stage cancer patients.

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

The Helix Laboratory Platform is the first whole-exome sequencing platform to receive do novo authorization by the agency and paves the way for others.

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

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Over the next year or so, the investigators plan to sequence the genomes of 3,000 patients with cancer, heart disease, diabetes, or neurological disorders.

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

The Universities of Southampton and Leeds will lead the project with participation from Johnson & Johnson, Roche, Oncimmune, BC Platforms, Inivata, and NHS England.

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

Adaptive Biotechnologies, GlaxoSmithKline Collaborate on MRD Testing

Nov 05, 2020

Parents, Physicians View Genome Sequencing as Useful for Managing Care of Seriously Ill Infants

Nov 02, 2020

Regulatory Documents for Newly Approved Liquid Biopsy NGS Panels Detail Diverse Test Claims, Methods

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Oct 30, 2020

ESHG, ACMG Differ Starkly in Recommendations for Reporting Secondary Findings From Genomic Tests

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Oct 27, 2020

FDA Approves Foundation Medicine Liquid Biopsy Test as CDx for Three Targeted Therapies

Oct 14, 2020

Inspirata Partners With Carebox Healthcare on Automated Cancer Clinical Trial Matching

Oct 08, 2020

Germline Genetic Testing After Tumor Sequencing Can Uncover Clinically Actionable Variants

Sep 10, 2020

FDA Joins PGx Collaborative Community but Effect on Field is Unclear

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Sep 10, 2020

Helio Health Collaboration Aims to Evaluate Liquid Biopsy Test for Liver Cancer

Sep 03, 2020

Invitae Launches Study to Explore Impact of Testing Guidelines on Prostate Cancer Patients' Outcomes

Sep 02, 2020

BloodPAC Publishes Analytical Validation Protocols for NGS Liquid Biopsy Assay Development

Aug 27, 2020

Foundation Medicine Liquid Biopsy Gets FDA Approval for Multiple Companion Diagnostic Indications

Aug 25, 2020

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Genomics: Clinical Implementation

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

Parents, Physicians View Genome Sequencing as Useful for Managing Care of Seriously Ill Infants

Regulatory Documents for Newly Approved Liquid Biopsy NGS Panels Detail Diverse Test Claims, Methods

ESHG, ACMG Differ Starkly in Recommendations for Reporting Secondary Findings From Genomic Tests

FDA Approves Foundation Medicine Liquid Biopsy Test as CDx for Three Targeted Therapies

Inspirata Partners With Carebox Healthcare on Automated Cancer Clinical Trial Matching

Germline Genetic Testing After Tumor Sequencing Can Uncover Clinically Actionable Variants

FDA Joins PGx Collaborative Community but Effect on Field is Unclear

Helio Health Collaboration Aims to Evaluate Liquid Biopsy Test for Liver Cancer

Invitae Launches Study to Explore Impact of Testing Guidelines on Prostate Cancer Patients' Outcomes

BloodPAC Publishes Analytical Validation Protocols for NGS Liquid Biopsy Assay Development

Foundation Medicine Liquid Biopsy Gets FDA Approval for Multiple Companion Diagnostic Indications

ESMO Recommendations Outline Use of Next-Gen Sequencing in Metastatic Cancer Patients