Affymetrix GeneChip Arrays Elevated In Roche Pact, Considered By FDA
This article was originally published in The Gray Sheet
Executive Summary
Affymetrix' plans to establish its GeneChip as the standard platform technology for genomics-based diagnostics are bolstered by FDA enthusiasm for the probe microarrays, the company claims
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AmpliChip CYP450 pharmacogenomic microarray assay will generate over $100 mil. in revenue by 2008, Roche predicts. Launched as an analyte-specific reagent for CLIA-certified labs June 25, the test is the first pharmacogenomic microarray for clinical applications. Designed to detect variations in genes that play a role in how the body metabolizes drugs for conditions such as cardiovascular disease, high blood pressure, depression and ADHD, the test can facilitate drug and dosage selection and help avoid adverse reactions, Roche says. Approval as an in vitro diagnostic is expected in 2004. Furthering the creation of an "individualized medicine market," the firm says it plans to develop additional microarray diagnostics in the areas of HIV resistance genotyping, p53 cancer resequencing, colorectal cancer risk prediction, cystic fibrosis and human papilloma virus genotyping. The effort stems from a $70 mil. January pact to combine Roche PCR technology with Affymetrix' microarray platform (1"The Gray Sheet" Feb. 10, 2003, p. 6)...
Roche gene test for tailored drugs
AmpliChip CYP450 pharmacogenomic microarray assay will generate over $100 mil. in revenue by 2008, Roche predicts. Launched as an analyte-specific reagent for CLIA-certified labs June 25, the test is the first pharmacogenomic microarray for clinical applications. Designed to detect variations in genes that play a role in how the body metabolizes drugs for conditions such as cardiovascular disease, high blood pressure, depression and ADHD, the test can facilitate drug and dosage selection and help avoid adverse reactions, Roche says. Approval as an in vitro diagnostic is expected in 2004. Furthering the creation of an "individualized medicine market," the firm says it plans to develop additional microarray diagnostics in the areas of HIV resistance genotyping, p53 cancer resequencing, colorectal cancer risk prediction, cystic fibrosis and human papilloma virus genotyping. The effort stems from a $70 mil. January pact to combine Roche PCR technology with Affymetrix' microarray platform (1"The Gray Sheet" Feb. 10, 2003, p. 6)...
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