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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. 

In a survey conducted by an association working group, 40 percent of respondents said they are already offering TMB, with most others planning to do the same within the year.

Genetic testing results increasingly inform clinical decisions, though the inclusion of hereditary risk genes beyond BRCA1, BRCA2, and PALB2 sparked debate.

With a $3.7 million NIH grant, database developers hope to garner FDA recognition, develop a new user interface, and further integrate its use in cancer care.

CMS has attempted to address stakeholders' concerns about its coverage criteria for germline NGS testing in a new proposed national policy.

Negative results in recent trials have highlighted the challenges that newer genomic test makers must overcome in proving methods for personalized CUP treatment.