Array-based cytogenetic tests
This article was originally published in The Gray Sheet
Executive Summary
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