Advocacy - Lab Advocate
The Food and Drug Administration (FDA) sponsored a public workshop on March 2 entitled “Patient and Medical Professional Perspectives on the Return of Genetic Test Results,” which provided a forum for input on a series of questions regarding how genetic data should be reported to clinicians and patients. FDA is concerned that physicians and patients will have a difficult time interpreting next-generation sequencing data.
Specifically, the agency would like suggestions on the format for returning the genetic results and the information/evidence that should be provided to make the data interpretable. FDA is also seeking patient input on whether they would like to receive genetic test results that identify a condition for which there is no medical intervention.
AACC is currently reviewing the FDA’s request for feedback and developing a response. In addition to sending your comments to the FDA, the AACC Government Relations Committee urges you to send a copy to Vince Stine, PhD, AACC's director of government affairs, so that the group can consider your thoughts when drafting the association’s response.