AHRQ On Genetic Testing Data

Full brief reprinted from "The Gray Sheet" - June 2, 2008

There are over 1,000 gene-based tests in clinical use, and the global market is expected to reach $12.5 billion in 2009, AHRQ says.

More data are needed on the utilization, short- and long-term outcomes and cost-effectiveness of gene-based tests, according to an Agency for Healthcare Research and Quality report published May 21. The report, prepared by RTI International for AHRQ, assessed existing U.S. databases and found that “only limited, sporadic information is available on the utilization of gene-based tests over time.” Databases should have standard codes for genetic tests that clearly convey test type, reason for the test and results, and should incorporate architecture standards to link different databases, the report recommends. They also should address privacy concerns and reduce proprietary and regulatory barriers that inhibit data sharing. The report notes that surveys are needed to monitor the availability of genetic testing centers and counseling modeled, for example, on the National Ambulatory Medical Care Survey for medical clinics. Finally, the AHRQ document recommends developing pilot studies on clinical outcomes for a small set of diseases and tests, such as BRCA1/2 screening, newborn screening and genetic testing for warfarin drug therapy. There are over 1,000 gene-based tests in clinical use, and the global market is expected to reach $12.5 billion in 2009, AHRQ says.

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