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'Viewpoint' addresses IOM report on genome-based therapeutics and companion diagnostics
Date:2/12/2014

resent the testing and medical insurance industry respectively, argue for stakeholders' support of "a strategy to co-develop and co-submit to the FDA a diagnostic test (companion diagnostic [CoDx]) that specifically targets a drug to patients predicted to respond." The authors share that "regulatory and business challenges . . . hamper the broader field of diagnostic testing" and not just the companion diagnostic pathway.

Currently, there are two pathways for test co-development the FDA's in vitro diagnostic (IVD) tests and laboratory-developed tests (LDTs). Each has its own set of regulations and safety measures, as well as costs and insurance reimbursement eligibility. "The coexistence of two test development pathways is problematic, especially for co-developed CoDx tests, and requires clarification," writes Leonard and colleagues.

As an example of the current co-development CoDx environment, Leonard provides a potential scenario of a lung cancer patient for whom an oncologist may be considering several different drugs for treatment. "The pathologist has to do multiple separate CoDx tests, unless the institution does its own LDT that combines all the individual tests into a single test," Leonard explains, which is done in some pathology laboratories, predominantly using next-generation genetic sequencing. This combined test reduces the number of tests required, can conserve tissue and produce more medically-relevant results. However, insurance payers will not always cover the breadth of the tests.

"A university-based lab can run a single test to assess 28 genes, but an insurance company might only cover three of the gene tests," she admits.

The "Viewpoint" article addresses reimbursement and other economic obstacles, such as the investment environment for CoDx co-development and the costs associated with performing laboratory tests. The IOM Roundtable workshop explored these challenges, as well as discussed solutions to the co
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Contact: Jennifer Nachbur
jennifer.nachbur@med.uvm.edu
802-656-7875
University of Vermont
Source:Eurekalert

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