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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.

An IASLC survey showed that molecular testing is not performed in line with expert guidelines, which means only a minority of lung cancer patients are benefitting from precision oncology.

The group notes the importance of lab CLIA certification, clear test reports, and clinical validity support for test claims in the literature, guidelines, and FDA labels.

As NGS testing becomes more widespread, labs, payors, and professional groups confront questions about which genes should be required as part of clinical assays.

The organizations provided a list of genes they believe are informative in treatment of myeloid disorders and suggested several changes to the coverage policy.

The organization continues to support direct access genetic testing for healthcare decision making, while remaining neutral on recreational, novelty, lifestyle, and ancestry genetic testing.

A draft bill provides for a major expansion of eligible material, a move the ACLU and AMP said threatens to reduce competition in genetic testing.

Call to Undo

An opinion piece appearing at Stat News calls the CMS decision to limit access to next-generation sequencing-based tests for hereditary cancers a "grievous error."

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

In a letter to CMS, AMP made a case for crosswalking existing CPT codes for BRCA1/2 testing to codes that more accurately reflect the work required to analyze these genes.

Pages

The US Department of Justice has proposed a rule change to enable DNA to be collected from migrants, the Associated Press reports.

Bernard Fisher, a surgeon who changed how breast cancer is treated, has died at 101, the New York Times reports.

Washington Post columnist writes that she is skeptical about DNA-based diets.

In PNAS this week: recurrent inactivation of DEPDC5 in gastrointestinal stromal tumors, taxonomic reliability of GenBank sequences, and more.