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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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ScienceInsider reports that rude and unprofessional paper reviewers are common and can have harmful effects.

The US Senate has confirmed Stephen Hahn as the next commissioner of the Food and Drug Administration, according to the New York Times.

CNBC reports Apple is partnering with Color Genomics to offer its employees free DNA screening for disease.

In Science this week: researchers use CRISPR tool to find gut microbiome molecules involved in immunity, and more.