Direct Access Genetic Testing - Consumer Caution

Author: Association for Molecular Pathology
Published: 2010/05/14
Topic: Recalls, Warnings and Advisories - Publications List

Page Content: Synopsis - Introduction - Main

Synopsis: Genetic tests should be provided to the public only through the services of appropriate health care professionals.

Introduction

AMP cautions consumers about direct access genetic testing

Main Item

In response to recent announcements about consumer genetic tests being made available in retail drugstores, the Association for Molecular Pathology (AMP) today reiterated its position that these tests should be provided to the public only through the services of appropriate health care professionals that order tests from laboratories that are certified by CLIA for high-complexity testing.

"Genetic testing continues to be an integral part of health care and there is great potential for future test development and use as long as they are administered properly and interpreted in the context of the overall medical evaluation of each patient," said AMP President, Karen Mann, M.D., Ph.D. "AMP is concerned that these types of direct access genetic tests will mislead consumers by making predictions that are medically unproven or not meaningful and promoting purchase of products not proven to be medically useful."

AMP is an international medical and professional association representing approximately 1,800 physicians, doctoral scientists, and medical laboratory scientists who perform laboratory testing based on knowledge derived from molecular biology, genetics, and genomics. Our members are dedicated to the development and implementation of molecular pathology testing, including genetic testing, in a manner consistent with the highest standards established by the Clinical Laboratory Improvement Amendments (CLIA), the College of American Pathologists (CAP), the American College of Medical Genetics (ACMG), and the U.S. Food & Drug Administration (FDA).

The Association for Molecular Pathology (AMP) is an international medical professional association dedicated to the advancement, practice, and science of clinical molecular laboratory medicine and translational research based on the applications of molecular biology, genetics and genomics. For more information, please visit: www.amp.org.

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