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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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The Washington Post reports that Herbert Tabor, who worked at the US National Institutes of Health for 77 years, has died at 101.

The World Bank is seeking approval for a $12 billion plan to provide low-income nations with funds to procure SARS-CoV-2 vaccines, according to Reuters.

Science writes that public health officials and others are debating whether cycle threshold values should be included on SARS-CoV-2 results.

In Nucleic Acids Research this week: online database of SARS-CoV-2 protein structures, atlas of the human brain, and more.