Microarray-based assay can be used on FFPE samples to help identify primary tumor site.
Pathwork Diagnostics raised $30 million in a Series C financing round led by Alta Partners. Existing investors in Pathwork also participated. The firm said the new injection of capital will be used to support commercial activities and expand its range of products.
Pathwork’s flagship Pathwork® Tissue of Origin Test for formalin-fixed, paraffin-embedded (FFPE) tissue samples was approved by FDA in June. Developed to help identify the primary cancer in cases that are otherwise difficult to classify, the test uses custom-designed Affymetrix microarray technology to measure the expression patterns of some 2,000 genes in fixed sample, and compare them with RNA expression patterns from a database of 15 tumor types that represent some 90% of all solid tumors. Results from the test will then be evaluated in the context of the patient’s clinical history and complementary diagnostics, such as immunohistochemistry. The Pathwork test is the only FDA-cleared molecular classification test for tissue of origin, the firm claims.
The Tissue of Origin Test is currently available through Pathwork’s own CLIA-certified laboratory. However, the firm says it aims to transition the test from a laboratory-developed test to an in vitro diagnostic. It also plans on making an IVD kit available to those who want to run the test in their own clinical laboratories. Clearance of Pathwork’s flagship product “opens the door for future tests to be offered on the Pathwork platform,” commented Deborah J. Neff, CEO, on FDA’s approval.
Pathwork’s original Tissue of Origin Test, for use with frozen tissue samples, was cleared by FDA in July 2008.