The Centers for Disease Control and Prevention (CDC) has released the first federal government recommendations to promote accurate and appropriate use of molecular, or DNA-based, genetic tests, according to a recent press release.

The CDC guidance, entitled "Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions," is available on the Morbidity and Mortality Weekly Report website. The CDC says the guidance offers recommendations for clinical and public health professionals and those evaluating laboratory practices and policies.

The guidance highlights areas of molecular genetic testing that have been recognized by the Clinical Laboratory Improvement Advisory Committee as needing specific guidelines for compliance with existing CLIA requirements or needing quality assurance measures in addition to CLIA requirements. In addition, the guidance provides CLIAC recommendations for good laboratory practices to ensure the quality of molecular genetic testing for heritable diseases and conditions.

The recommended laboratory practices provide guidelines for ensuring the quality of the testing process, laboratory responsibilities regarding authorized persons, confidentiality of patient information, personnel competency, as well as factors to consider before introducing molecular genetic testing or offering new molecular genetic tests. Implementation of the recommendations is expected to prevent or reduce errors, improved use of molecular genetic laboratory services, and better health outcome for patients, the guidance says.

The CDC says molecular genetic testing is one of the fastest growing areas of laboratory testing in the United States. Concerns are rising, the CDC notes, over the growth of direct-to-consumer testing (sometimes without oversight) and potential misuse of the genetic tests.

DNA-based genetic tests are used for decisions in patient care, including risks for a genetic disease or potential for chronic diseases. "Getting an accurate diagnosis influences a patient's course of treatment and how they deal with a disease or disease threat," the CDC stated in the press release. "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."

The guidance may be found at: http://www.cdc.gov/mmwr/mmwr_rr.html

Based upon a press release by the Centers for Disease Control and Prevention.

Link: http://www.cdc.gov/media/pressrel/2009/a090611b.htm

More Industry Headlines