Diagnostic Kits/SACGHS U.S. System of Oversight of Genetic Testing

Report of the Secretary’s Advisory Committee on Genetics, Health, and Society, U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services, April 2008. Available at: http://oba.od.nih.gov/oba/SACGHS/reports/SACGHS_oversight_report.pdf [Accessed July 8, 2009].

Map of US Oversight for Genetic Testing

The report points out that at "(G1) there is a need for reference materials for assay, analyte, and platform validation to establish that new tests are accurate."

This image presents a map of the US regulatory process for diagnositics and implicitly demonstrates the diagnostic development pipeline.

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