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FDA Clears Pathwork's Tissue-of-Origin Cancer Test for Affy Platform

NEW YORK (GenomeWeb News) – The US Food and Drug Administration said today that it has cleared for marketing a microarray-based test from Pathwork Diagnostics that determines what type of cancer cells are present in a malignant tumor.
 
The Pathwork Tissue of Origin test is based on Pathwork’s PathChip gene-expression array, which runs on Affy’s GCS3000Dx diagnostic platform. The test considers 15 common malignant tumor types, including bladder, breast, and colorectal tumors.
 
“In the past, scientists have classified different types of cancers based on the organs in which the tumors develop. With the help of microarray technology, they will be able to classify these types of cancers in a standardized non-reader dependent manner based on the patterns of gene activity in the tumor cells," said Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, in a statement.
 
The Pathwork Tissue of Origin test is the second in vitro diagnostic multivariate index assay, or IVDMIA, device to be cleared by the FDA, following Agendia’s MammaPrint test, which the agency approved in February 2007.
 
Kevin King, president of Affymetrix, said in a statement that FDA clearance of the Pathwork Tissue of Origin Test “not only expands the menu on our diagnostic platform, but opens the door for other gene expression-based diagnostic tests that are currently being developed by Affymetrix and our [Powered by Affymetrix] partners on the GCSDx platform.”
 
The company said that there are currently more than 20 such tests under development for its platform.
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