AACC Urges Lab Involvement in Ordering/Interpreting Genetic Test Results

On March 2, the Food and Drug Administration held a workshop to explore the Patient and Medical Professional Perspective on the Return of Genetic Test Results.  The Agency’s stated purpose for the meeting was to gather input from the healthcare community on how such information should be communicated with and between clinicians and patients.  The FDA heard testimony from a variety of groups representing clinicians, healthcare professionals, and consumers.

Among those testifying at the workshop was the American Medical Association, which questioned whether the FDA should be involved in this issue.  The physician group asserted that the appropriate presentations of test results is best determined by the clinician and patient—not the government.  The March of Dimes took a different approach, urging the FDA to standardize the reporting process to assist clinicians and patients in interpreting the data.   

AACC submitted public comments supporting the agency’s efforts to gather information on the reporting of genetic test results and how the process could be improved.  The Association recommended:

• Patients be educated about the risk, benefits, and costs associated with genetic testing;
• Clinicians work with laboratory professionals when ordering and interpreting tests; and
• Materials be developed to help consumers understand the value and limits of genetic testing.

AACC also urged the agency to work with the healthcare community on patient education.  The FDA public workshop has been archived on the FDA website.