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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.

At least two early-access users, at Massachusetts General Hospital and at Weill Cornell, have explored the new platform for infectious disease testing.

At a Thermo Fisher-sponsored workshop, two companies argued for the clinical utility of PGx LDTs as FDA prepared to issue a warning against unapproved tests.

Researchers separately found that the assay had high concordance with other techniques in cancers including colorectal and endometrial carcinomas.

Company officials stressed the firm's drive to help connect industry and academia, and expand access to tools for precision medicine.

Roche said at the AMP annual meeting that it plans to commercialize the system in Europe with CE IVD marking for clinical applications and in the US with a 510(k) exemption.

The working group reviewed data to identify a minimum of 34 commonly mutated genes that should be included in pan-myeloid targeted panels.

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


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The New York Times Magazine examines gender discrimination at the Salk Institute.

Science reports that MD Anderson Cancer Center has dismissed three researchers over foreign tie concerns.

A second death in gene therapy trial for type 1 spinal muscular atrophy is under investigation, according to Reuters.

In PLOS this week: antibiotic resistance patterns in Escherichia coli, a dozen genetic loci tied to varicose vein risk, and more.