FDA approves tumor identification test

WASHINGTON, July 31 (UPI) -- The U.S. Food and Drug Administration has approved a test that can identify cancer cells contained within a malignant tumor.

The FDA said the Pathwork Tissue of Origin test compares the genetic material of a patient's tumor with genetic information on malignant tumor types stored in a database. It uses a microarray technology to analyze thousands of pieces of genetic material at one time. The test considers 15 common malignant tumor types, including bladder, breast and colorectal tumors.

"The clearance of the Pathwork test is another step in the continued integration of molecular-based medicine into standard practice," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. "In the past, scientists have classified different types of cancers based on the organs in which the tumors develop."

The FDA said the Pathwork Tissue of Origin test was found to provide a level of accuracy similar to that achieved by expert pathologists using current standards of practice.

PathChip, the gene expression array used in the Pathwork Tissue of Origin test, is custom-designed for Pathwork Diagnostics of Sunnyvale, Calif., by Affymetrix Inc. of Santa Clara, Calif.