FDA Recognizes Role of Genetic Counselors in DTC Testing A Statement from the National Society of Genetic CounselorsMarch 2011
The Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee to the Food and Drug Administration (FDA) recognized the important role that genetic counselors should play in direct-to-consumer genetic testing. The National Society of Genetic Counselors (NSGC) applauds the Panel’s recognition of certified genetic counselors as having expertise that supports physicians and patients throughout the testing process and specifically ensuring there is an understanding of what genetic test results do and do not mean.
“Genetic tests have the potential to uncover life-altering information, both positive and negative. It is very important for patients to understand the context and ramifications of the information revealed by a test,” said Karin Dent, president of NSGC. “To avoid misinterpreting results that can lead to false reassurance or unnecessary anxiety, it is important that a certified genetic counselor and qualified health care provider are involved to interpret test results in light of other risk factors.”
NSGC also applauds the American Medical Association for its Feb. 23, 2011, letter to the Panel calling for genetic testing to be conducted under the guidance of a physician, genetic counselor or other genetics specialist.
Without the guidance of a genetic counselor when using DTC testing:
1. You may receive a battery of test results without proper context and you will not receive answers to your questions.
2. You may receive test results that are alarming without an expert to talk to about your concerns.
3. You may not know what action you can take based on the test results or you may be paying for information you already know
Genetic counselors work closely with physicians to help patients determine if and when they should undergo genetic testing. It is important that someone who has expertise in genetics helps you understand and interpret your test results. For example, genetic counselors have specialized training in medical genetics and counseling and have master’s degrees in their field.
For more information or to find a genetic counselor in your area, visit www.nsgc.org.
About the National Society of Genetic Counselors
NSGC is the leading voice, authority and advocate for the genetic counseling profession, representing more than 3,000 health professionals. The organization is committed to ensuring that the public has access to genetic counseling and genetic testing. For more information, visit www.nsgc.org.
NSGC Media Contact:
Public Communications Inc.