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While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.

The industry organization issued a letter urging the agency to reconsider recent decisions to demand several laboratories stop offering pharmacogenetic testing.

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

CMS had received significant stakeholder feedback that germline NGS testing is not the same as somatic testing, and that the NCD as written would negatively impact patients.

The diversity of the organizations that have signed the letter to CMS demonstrates widespread concern over this policy.

CMS's move to restrict coverage could limit test access for early-stage cancer patients and negatively impact lab revenues.

At the Personalized Medicine Conference this week, stakeholders historically at odds over lab test regulation said it is up to Congress to resolve the issue.

Seventeen organizations don't support the Diagnostic Accuracy and Innovation Act as written and would like lawmakers to advance a CLIA-centric framework.


The agency asked Reps. Bucshon and DeGette to consider the precertification program idea as they work on refining the draft of the Diagnostic Accuracy and Innovation Act.

These lobbying efforts aim to shore up willingness among legislators to step in and halt implementation of the NCD if certain provisions remain in the final version.

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23andMe has a holiday popup shop at a mall and could open additional stores, Bloomberg reports.

By studying koalas and a retrovirus that infects them, researchers may have uncovered a new sort of 'immune response' that occurs at the genomic level, Agence France Presse reports.

NPR reports that the first person in the US given a gene editing-based therapy for a genetic disorder is heading home.

In Science this week: ancient genomes reveal social inequality within individual households, new method for quantifying genetic variation in gene dosage, and more.