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National Cancer Institute Develops Checklist to Determine Readiness of an Omics Test

The National Cancer Institute (NCI) developed a checklist with 30 criteria for determining the readiness of an omics test for use in guiding patient care in clinical trials, based on the principles set forth in the IOM report Evolution of Translational Omics: Lessons Learned and the Path Forward. The checklist will be used when reviewing proposals for NCI-sponsored clinical trials in which omics tests will guide care.

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News Release

IOM Report Recommends Evaluation and Validation Process to Prevent Problems Associated With Turning 'Omics' Research Into Clinical Tests
Released: 3/23/2012

Genomics, proteomics, and other branches of molecular bioscience offer the prospect of greater precision in medical care, but some clinical tests based on "omics" research have proved invalid and highlighted the challenges of dealing with complex data. To enhance the translation of omics-based discoveries to clinical use, a new report by the Institute of Medicine recommends a detailed process to evaluate whether the data and computational steps underlying such tests are sound and the tests are ready to be used in clinical trials. The proposed process defines responsibilities and best practices for the investigators, research institutions, funders, regulators, and journals involved in development and dissemination of clinical omics-based technologies.

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Media Advisory

IOM Report on Improving “Omics-Based” Test Development Releases March 23
Released: 3/21/2012

Genomics, proteomics, and other branches of molecular bioscience offer the possibility of greater precision in medical care by tailoring therapies to patients' genetic or molecular profiles. But some clinical tests based on "omics" research, including tests developed by researchers at Duke University to select chemotherapy for cancer patients, have proved invalid. Evolution of Translational Omics: Lessons Learned and the Path Forward, a new report from the Institute of Medicine, recommends steps to help avoid future problems associated with moving omics-based discoveries from the lab to clinical settings.

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