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IOM Committee Starts 'Omics Test Review

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The Institute of Medicine has started a new committee that will look at predictive 'omics-based tests and eventually issue a report and recommendations on how to determine when these tests are fit for use as a basis for designing clinical trials, for stratifying patients, and measuring patient response in clinical trials.

The IOM committee will conduct its first meeting with members of the US Food and Drug Administration, the National Cancer Institute, and other stakeholders and members of the public on December 20. It expects to release its first report in around 15 months.

At its meeting next week, the Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials will discuss what its tasks and goals will be and will hear presentations from NCI and FDA. The committee also will identify the topics it plans to look at in future meetings and form working groups that will collect evidence and develop materials for its final report.

Although the specific details of the committee's tasks remain uncertain, its charge is to review the published literature to identify what criteria will be appropriate for evaluating tests based on 'omics tools, including genomics, epigenomics, proteomics, and metabolomics tests.

After conducting this review, the committee will recommend an evaluation process for when these tests are fit for use in designing and stratifying trials and measuring patient response. The group also will identify which criteria are important for the analytical validation, qualification, and utilization components of the test evaluation process.

After developing those evaluation criteria, the committee then will apply them to three cancer clinical trials conducted by researchers at Duke University. For example, one of these Duke studies involved partnering with Eli Lilly and used Affymetrix gene-expression data with corresponding drug-response data to provide personalized chemotherapy regimens for two types of lung cancer.

Although how the committee will apply these criteria has not yet been determined, several approaches may be used. The committee may assess the analytical methods used to generate and validate the predictive models, examine how the source data were used to develop the test and how the predictive models were generated, or evaluate the use of predictive models in clinical trials, according to IOM.