Media Advisory

CDC Releases New Guidance on Genetic Testing

Who:

TheCenters for Disease Control and Prevention is releasing the first federal government recommendations to foster accuracy and appropriate use of molecular, or DNA-based, genetic tests.

What:

The guidance, entitled "Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions," addresses considerations for clinical and laboratory professionals that are important for achieving patient benefits and avoiding medical mistakes when molecular genetic tests are used. These include ensuring proper test method selection and test performance, as well as appropriate test result reporting, interpretation and use. The guidance also covers factors to consider before introducing new tests and what qualifications laboratory personnel should have to perform testing.

The recommendations are intended for use by clinical and public health professionals, and those evaluating laboratory practices and policies.

Why:

Molecular genetic testing is one of the most rapidly growing areas of laboratory testing in the United States. The number of genetic diseases and conditions for which tests are available has more than tripled from 423 in the past eight years to more than 1,300 today. The growth of direct-to-consumer testing – which is permitted in 37 states and often done without oversight – has raised additional concern about the potential misuse of genetic tests.

DNA-based genetic tests are used to help make decisions about patient care, such as whether patients have or may be at risk for a genetic disease such as cystic fibrosis or whether they may be prone to chronic diseases including cancer, diabetes and blood clotting disorders. Getting an accurate diagnosis influences a patient’s course of treatment and how they deal with a disease or disease threat. Implementation of the genetic testing guidance can improve accurate diagnoses and ultimately ensure that patients and their doctors can make the best decisions for their health.

When:

The report is under embargo until 12 p.m. ET today.

Where:

The new recommendations are available through the CDC's MMWR website at http://www.cdc.gov/mmwr/mmwr_rr.html.

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES