Roche Outlines ASR, Microarray Changes Made In Response To FDA Letter
This article was originally published in The Gray Sheet
Executive Summary
Roche Diagnostic microarrays will be sold as research-use only tests until the firm is able to seek in vitro diagnostic status, Robert Gregg, PhD, director of regulatory submissions, explained during the American Association of Clinical Chemistry annual meeting in Los Angeles July 26
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Affymetrix/Roche microarray
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)...
Affymetrix/Roche microarray
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)...