Facing Prospect of Increased FDA Regulation, Vendors Look to Clear Cyto Chips for Clinical Use | GenomeWeb

By Justin Petrone

Roche NimbleGen has joined rivals Affymetrix, Agilent Technologies, and Illumina in announcing its intention to seek US Food and Drug Administration clearance for the use of its arrays in the clinical diagnosis of genetic abnormalities.

The decision of major array vendors to seek FDA clearance for their cytogenetic array platforms comes at a time when the agency has indicated that it could require labs that offer array-based chromosomal analyses to use cleared tests in the future.

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