IOM Identifies Goals for Advancing Biomarker Tests for Molecularly Targeted Therapies

In March, the Institutes of Medicine (IOM) released a report, Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine, which explores the clinical, reimbursement, regulatory and data challenges associated with biomarker testing.  The report makes a series of recommendations urging policymakers to: 

• Establish common evidentiary standards of clinical utility;
• Establish more coordinated and transparent federal regulatory and payment processes;
• Update and strengthen laboratory oversight practices; and
• Improve clinical practice guidelines.

Although the IOM study group urged stronger oversight for laboratory developed tests, it did not address whether the Food and Drug Administration or Centers for Medicare and Medicaid Services should take the lead.  The panel did suggest, however, that test reimbursement be linked to meeting certain “predefined clinical and evidentiary criteria.”  In addition, the IOM suggests a ranking system be developed to help healthcare professionals assess the level of evidence associated with clinical validity and clinical utility of each intended clinical use of a test.

IOM studies are frequently used by legislators and agency personnel to make policy decisions.  AACC will report on future developments involving these recommendations in upcoming editions of Lab Advocate.