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CDC Releases First Genetic Testing Guidelines

Guidelines to standardize testing procedures and prevent misuse of results in advising patients

FRIDAY, June 12 (HealthDay News) -- With the number of tests for genetic conditions having more than tripled since 2001, the U.S. Centers for Disease Control and Prevention (CDC) has announced the release of the first federal guidelines for the use of molecular, or DNA-based, genetic testing.

Prepared by Bin Chen, Ph.D., of the Coordinating Center for Infectious Diseases in Atlanta, and colleagues, "Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions" covers lab personnel qualifications, testing methods, test performance, result reporting, interpretation and appropriate use in advising patients. The guidelines are intended for clinicians, public health professionals, and those charged with oversight of laboratories.

Genetic testing in the United States has grown rapidly in recent years. The number of genetic conditions for which tests are available has increased from 423 to more than 1,300 since 2000. Meanwhile, direct-to-consumer testing, which is allowed in 37 states, has raised concerns about the potential misuse of genetic tests in making patient care decisions.

"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," the CDC said. "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."

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