Affymetrix/Roche microarray
This article was originally published in The Gray Sheet
Executive Summary
GeneChip System 3000Dx, on which Roche's AmpliChip CYP450 test can be run, garners CE mark for diagnostic use in Europe, Affymetrix announces Sept. 1. Roche encountered problems in the U.S. when it sought to market AmpliChip as an analyte-specific reagent, exempt from premarket notification. The firm subsequently said it would offer AmpliChip as a research-use only test in the U.S. until further notice (1"The Gray Sheet" Aug. 9, 2004, p. 13)...