GeneChip technology, through the MyGeneChip Custom Array Program, enables researchers to perform large-scale resequencing with uniform sequence coverage, long read lengths to minimize curation and assembly time, high accuracy and reproducibility, and efficient data management, while reducing the overall cost per base.
The authorization of the RM-Flu test builds on the success of our MyGeneChip Custom Program, including GeneChip?® Resequencing Arrays for researchers and labs such as Harvard Partners and GeneDx, said Kevin King, president and CEO of Affymetrix. This is the first microarray-based authorized test for this virus utilizing MyGeneChip Custom Array technology.
Affymetrix technology has been used twice in products cleared by the FDA for use in in vitro diagnostics. In July 2008, the FDA cleared the Pathwork?® Tissue of Origin Test from Pathwork Diagnostics, Inc., for use in determining the origin of uncertain tumors. In January 2005, the FDA cleared the AmpliChip?® CYP450 for diagnostic use in the United States. This was the first microarray-based diagnostic test for detection of genetic variations that can influence drug efficacy and adverse drug reactions.
Source TessArae, LLC