Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Array-based cytogenetic tests: The Cleveland Clinic and the College of American Pathologists disagree on whether cytogenetic diagnostic arrays are ready for prime time, according to July 30 comments to FDA. The agency is carving out a regulatory policy for the complex assays, which detect DNA copy number changes that may indicate disease (1"The Gray Sheet" July 12, 2010). Cleveland Clinic 2cautions that "our current ability to conduct array-based cytogenetic tests exceeds our understanding of the pathophysiology behind some of these findings." Labs should standardize test interpretation and reporting approaches, the clinic writes, and results should be presented by a genetic counselor. The college of pathologists, on the other hand, says the tests "are not unlike numerous other laboratory tests" used today and should not be "unduly restricted" by FDA. "Patient care is compromised when diagnostic testing services are less readily and affordably available because of burdensome regulation," CAP 3writes. The group suggests databases and criteria that could be used to distinguish benign from pathogenic test findings