Pathwork Gets FDA Clearance for Tissue of Origin Test

The FDA has cleared Pathwork Diagnostics’ Tissue of Origin Test to determine the origin of uncertain tumors.

The test uses a microarray to analyze a tumor’s gene expression pattern to help pinpoint the source of hard-to-identify tumors. The expression pattern in the tumor is then compared with the patterns of 15 known tumor types to determine the tumor’s origin, the company said.

Pathway estimates that each year up to 200,000 newly diagnosed cancer patients in the U.S. may have a tumor for which the site of origin is uncertain initially.