Close Menu

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. 

As labs implement TMB workflows in-house, studies are showing that its is possible to validate assays with cutoff points remaining stable across complex clinical cohorts and in different drug contexts.

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.

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

In response to CMS reopening its national coverage determination to address its germline testing policy, stakeholders point out areas of concern and confusion.  

After reviewing more than 100 studies, the panel issued recommendations focused on women with a personal or family history of BRCA1/2-related cancers or high-risk ancestry.