This article was originally published in The Gray Sheet
Executive SummaryFirm's NimbleGen subsidiary announced plans April 7 to start implementing good manufacturing practices for its DNA microarray products in preparation for seeking FDA clearance or approval for the diagnostics. NimbleGen makes microarrays for a range of applications, but the firm suggests that cytogenetics, or chromosome analysis, is likely to be the first area in which it will seek FDA labeling to move beyond research applications into clinical diagnostics
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