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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

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