FDA Attempts To Carve Out Regulatory Policy For Cytogenetic Tests
This article was originally published in The Gray Sheet
Executive Summary
FDA is taking a proactive look at a new type of complex genetic test that challenges the agency's typical model for reviewing and approving diagnostics
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Regulatory News In Brief
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
Regulatory News In Brief
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
Array-based cytogenetic tests
FDA will host a workshop on array-based cytogenetic tests June 30 to address challenges in performance evaluation, determining clinical significance, and results reporting and interpretation. Cytogenetic tests detect pathological genomic copy number changes in a patient's DNA to identify abnormalities. FDA says these complex, array-based tests challenge "the traditional method of FDA review." The meeting will take place in Bethesda, Md. Comments on questions posed in a June 8 Federal Register 1notice are due July 30