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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. 

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

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During a session at the ASHG 2020 virtual meeting, representatives from both organizations laid out the reasons for their contrasting guidelines.

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

FoundationOne Liquid CDx can now be used as a companion diagnostic for therapies to treat advanced ovarian, breast, and non-small cell lung cancer.

Inspirata Partners With Carebox Healthcare on Automated Cancer Clinical Trial Matching

Carebox's system matches eligibility criteria from clinical trial databases with patients' health and genomic data to identify potentially relevant studies.

Germline Genetic Testing After Tumor Sequencing Can Uncover Clinically Actionable Variants

An Invitae-led retrospective study found almost a third of cancer patients who underwent germline genetic testing after tumor sequencing had pathogenic variants.

FDA Joins PGx Collaborative Community but Effect on Field is Unclear

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The community is poised to be the primary channel for stakeholders to communicate PGx concerns with FDA, but it is unclear if all stakeholders will participate.

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

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

Aug 20, 2020

HHS Says FDA Can't Regulate Lab-Developed Tests Without Notice, Comment Rulemaking

Aug 17, 2020

Bionano Genomics Expecting Clinical Validation Studies to Drive Platform Adoption

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Aug 07, 2020

Wide Variation in Genomic Testing Utilization Across US, Report Finds

Jul 24, 2020

TMB Harmonization Effort Yields Calibration Method to Correct Inter-Assay Variation

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Jul 15, 2020

Canadian Consortium Launches C$2.6M Liquid Biopsy Initiative to Improve Targeted Cancer Treatment

Jul 15, 2020

Sema4 Nabs New York State Approval for Cancer Somatic Sequencing Tests

Jul 14, 2020

Dante Labs Software Nabs CE Mark for Interpretation of Whole-Genome Sequencing Data

Jul 10, 2020

Presence of cfDNA, CTCs Predicts Recurrence in Triple-Negative Breast Cancer

Jul 01, 2020

Yale, NBA Validating RNA Extraction-Free Saliva Test for Coronavirus

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Jun 18, 2020

State-Funded Rapid WGS Pilot Improves Outcomes, Saves Costs in Critically Ill California Newborns

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Jun 12, 2020

Liquid Biopsy Startup C2i Genomics to Launch International Validation Trials for MRD Detection Tech

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Jun 10, 2020

Cancer Experts Develop Precision Medicine-Based Genetic Testing Framework for Prostate Cancer

May 27, 2020

Illumina, Genomic Medicine Sweden to Evaluate Sequencing-Based Leukemia Diagnostics

May 21, 2020

Q&A: ACMG Work Group Hoping to Spark Discussion on Reporting Germline Findings From Tumor Testing

May 20, 2020

Bio-Techne Bets Clinical Utility Study Data Will Sway Payors to Cover Prostate Cancer Risk Test

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