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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.

The American Academy of Family Physicians said that the changes being considered by CMS would increase the financial burden on laboratories.

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 agency addressed industry stakeholder's concerns about its proposed diagnostic regulatory framework at the American Clinical Laboratory Association's annual meeting.

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.

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.

MHRA has also published a draft guidance for institutions that offer such tests so that they can gain compliance with the new directive.

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