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LDTs

The Columbia Solid Tumor Panel, a custom NGS panel from Pillar Biosciences, will be used at CUMC's Laboratory of Personalized Genomic Medicine.

How labs — including those that are part of other healthcare systems — offering PGx testing will react to Inova's decision to not engage with the FDA remains to be seen.

Pharmacogenetics and legal experts took particular issue with the agency's suggestion that "established" drug/gene relationships are found only in FDA-approved drug labels.

The discussion draft includes the regulatory proposals, including precertification, the FDA provided to legislators in a technical assistance document.

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.

At his FDA Law Blog, Jeffrey Gibbs discusses FDA's technical assistance for the draft Diagnostic Accuracy and Innovation Act.

The agency's regulatory plan differs in key areas from a draft of the Diagnostic Accuracy and Innovation Act that had shored up lab industry support.

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


Clinicians are using Roche's Cobas Omni Utility Channel to run lab-developed PCR tests alongside in vitro diagnostic kits, freeing valuable resources for labs.

The year brought more FDA approvals for molecularly targeted drugs and NGS tests for personalizing cancer treatment, but reimbursement remained a stress point for industry.

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The Hill reports President Donald Trump issued an executive directing federal agencies to cut the number of board and advisory committees they have.

Scientists in Canada are looking to the UK's plan to sequence children with rare conditions for inspiration, the National Post reports.

The New York Times reports that researchers are combining tools to more quickly develop crops to feed a growing population and cope with shifting climates.

In PNAS this week: copy number changes arose during polar bear evolution, genomic and transcriptomic analysis of the Siberian hamster, and more.