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IOM Considers Companion Dx

A clearer and more certain regulatory environment will be required for US businesses working on co-developed companion diagnostic tests to be able to tap the potential such tests offer for personalized medicine, according to a new editorial in the Online First publication of the Journal of the American Medical Association.

Robert McCormack, Joanne Armstrong, and Debra Leonard write, in response to a new publication of workshop notes on companion diagnostics and genome-guided therapies from the Institute of Medicine, even though over 100 therapeutics have biomarker tests recommended for them in their FDA labels, "significant opportunity remains untapped."

The IOM summary, "Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostics," includes several suggestions that were mentioned at a workshop IOM led last year.

Speakers at the workshop suggested that regulatory oversight of LDTs is needed, whether through more robust CLIA processes or a risk-based approach by FDA; that a mechanism for regulating follow-on tests could provide economic incentives for IVD and LDT developers to produce diagnostics; that rather than specific tests being named for drug responses the companion analytes and performance characteristics of tests could be specified; that the same molecular tests to diagnose and classify diseases could be used for patient selection for drug trials; that well-defined standards of evidence for the clinical utility of tests and the processes for generating that evidence are needed for determining intended uses, and other suggestions.

The JAMA authors explain that the workshop stakeholders identified several particular challenges facing companion diagnostics co-development efforts, including an uncertain regulatory environment, a weak business case for investing in companion diagnostics, and clinical, ethical, or legal constraints of implementing these tests in today's healthcare environment.

"These challenges have the potential to limit continued progress and investment in targeted therapies and CoDx tests, especially for diagnostic test manufacturers," they write.

"The present environment for the codevelopment of a CoDx test with a therapeutic agent is not sustainable, and no easy solution is apparent," they write.
However, they note, FDA is working on the problem.