Roche/Affymetrix microarray test cleared
This article was originally published in The Gray Sheet
Executive Summary
Affymetrix grants Johnson & Johnson/Veridex non-exclusive access to its GeneChip System 3000Dx technology to develop and market in vitro cancer diagnostics, the firm announces Dec. 28. Five days earlier, FDA cleared Roche Molecular Systems' AmpliChip cytochrome P450 genotyping test for use with GeneChip to assess drug metabolism. According to the agency's Dec. 23 release, which hails AmpliChip as "the first DNA microarray test to be cleared by FDA," the P450 enzyme affects optimum dosage for chemotherapy, antidepressants, anti-psychotics and beta-blockers, among other drugs. The test "should be used along with clinical evaluation and other tools to determine the best treatment options for patients," FDA stipulates. Roche was requested to submit a 510(k) application for the test after FDA faulted the company for promoting the product, originally an analyte-specific reagent, as a stand-alone diagnostic (1"The Gray Sheet" July 14, 2003, p. 20)...