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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. 

Myriad Genetics, University of Leeds Collaborate on Prolaris Clinical Utility Study

The study will evaluate how Prolaris impacts prostate cancer treatment decisions, and how those decisions impact costs within UK's National Health Service.

Large-Scale Multigene Panel Study of Hereditary Cancer Risk Refines Gene Associations

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The team analyzed multigene panel test data from Ambry Genetics for 165,000 individuals, focusing on hereditary cancer risk related to 32 genes in six cancer types.

AMP Issues Recommendations to Labs for Responsible PGx Test Offerings

The group notes the importance of lab CLIA certification, clear test reports, and clinical validity support for test claims in the literature, guidelines, and FDA labels.

Genetic Testing Can Guide Medication Decisions After Heart Procedure, Study Finds

A European study, published today in NEJM, used a POC, PCR-based system to perform CYP2C19 genotyping to guide platelet inhibitor therapy.

Veterans Health Administration Precision Oncology Program Successfully Profiles Advanced Tumors

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Since 2016, the VHA has routinely profiled molecular features in advanced cancers from vets in its care, even in rural locales, though challenges remain.

Aug 26, 2019

Stakeholders Voice Concerns, Push Back on NCD for NGS Cancer Panels

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Aug 20, 2019

USPSTF Formalizes Slightly Expanded BRCA Screening Recommendations

Aug 13, 2019

Complex Genetic Testing Errors Emerge Amid Increasing Panel Use, Consumer Access, Case Series Finds

Aug 07, 2019

Australian Team Builds Federated System for Integrating Genomics Into Healthcare

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Aug 02, 2019

Comparison of KRAS Liquid Biopsy Kits Confirms Differences at Low Mutant Allele Fraction

Aug 02, 2019

Legislators Introduce Bill to Increase Whole-Genome Sequencing Access for Pediatric Illnesses

Aug 02, 2019

Harmonizing NGS Test Panels Remains a Challenge for Clinical Sequencing

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Jul 10, 2019

Multi-Gene Panel Testing Moderately Cost Effective for Lung Cancer Patients

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Jun 21, 2019

Liquid Biopsy Monitoring, Surveillance Efforts Accelerate Across Cancer Types and Technologies

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Jun 21, 2019

Cascade Testing for Dilated Cardiomyopathy Likely to Be Cost Effective, Analysis Finds

Jun 21, 2019

AMP and CAP Comment on Palmetto Proposed Guidelines for NGS Testing of Myeloid Disorders

Jun 17, 2019

Clinical PGx Consortium Taking Aim at Non-Actionable Genes, Countering 'Inappropriate' Marketing

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Jun 10, 2019

AMP Updates Position Statement on DTC Genomic Testing

May 24, 2019

Multi-Site Study Tests Power of Commercial Reference Materials in Comparing Liquid Biopsy Assays

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May 08, 2019

BillionToOne to Launch Noninvasive Prenatal Screening Test; Plans Liquid Biopsy Products

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May 03, 2019

Helix Eyeing Partnerships With Health Systems on Large Population Health Studies

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May 01, 2019

CMS Reopens National Coverage Determination for NGS Testing in Advanced Cancer

Apr 26, 2019

Inivata Clinical Validation Bolsters Liquid Biopsy Evidence Base, Aids Platform Comparisons

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Apr 24, 2019

Rady Team Automates Rapid Pediatric Sequence Interpretation for Rare Disease Dx

Apr 23, 2019

Illumina, Chinese Children's Hospital to Launch Newborn Sequencing Study

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