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Roche/Affymetrix Microarray Cleared for Clinical Use by FDA

MOLECULAR DIAGNOSTICS took a big step forward in December. During the month, the Food and Drug Administration (FDA) cleared the first microarray instrument system and microarray-based laboratory test for clinical use. The FDA announced on December 23, 2004 that it had cleared the Gene-Chip® System (GCS) 3000Dx for clinical use. Affymetrix, Inc. of Santa Clara, …

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