Views Differ On How Lab-Developed Tests Fit In FDA Companion Dx Guidance
This article was originally published in The Gray Sheet
Executive SummaryLaboratory-developed tests are not explicitly mentioned in FDA’s 12-page draft guidance on companion diagnostics issued this summer, but the issue attracted significant attention in written comments in response to the document.
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A CDRH representative tells a conference on drug/diagnostic co-development that it doesn’t matter how well designed a study for a therapeutic agent is if the accompanying biomarker-targeted test is not reliable and uniformly implemented.
The standards needed for reimbursement of molecular diagnostics are changing – especially with respect to genomics-based tests, with their potential impact on public health with respect to screening, prevention, and measuring response to treatment, as well as cost. As the complexity of the assay development and launch process has grown, so too has the emphasis on evidence and clinical effectiveness, as well as the importance of finding better ways to align test coding and reimbursement with clinical value. But a lack of coordination across agencies and commercial players makes an assessment of the impact of any changes on evidence demands problematic.
FDA aims to issue both a final companion diagnostics guidance document and a separate draft guidance on the co-development of drugs and tests in the coming months.