publication date: Mar. 11, 2016

National Academy of Medicine Calls for Integrated FDA-CMS Pathway for Biomarker Tests 


By Conor Hale

The National Academy of Medicine listed 10 goals for advancing the appropriate use of biomarker tests in precision medicine.

“How do we ensure patients have timely access to appropriate tests that may accurately direct targeted therapies, while at the same time protecting them from potential harm due to the adoption of poorly validated tests or inappropriately used tests?” the report asked, saying that broader implementation was being held back by a lack of consensus over evidentiary standards, inefficient and inconsistent regulatory and reimbursement approaches, the need for a framework for collecting patient data, and translating that data into improved patient outcomes.

The report concluded that “the full potential of precision medicine will not be realized without accurate, reliable, clinically useful, and appropriately implemented biomarker tests for molecularly targeted therapies.”

“Biomarker tests for molecularly targeted therapies represent a crucial area of focus for developing methods that could later be applicable to other areas of precision medicine. The appropriate regulatory oversight of these tests is required to ensure that they are accurate, reliable, properly validated, and appropriately implemented in clinical practice.

“Moreover, common evidentiary standards for assessing the beneficial impact of biomarker-guided therapy selection on patient outcomes, as well as the effective collection and sharing of information related to those outcomes, are urgently needed to better inform clinical decision making.”

The report, titled “Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine,” includes … Continue reading 42-10 National Academy of Medicine Calls for Integrated FDA-CMS Pathway for Biomarker Tests

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