FDA clears test for determining tumor origin

The test is the second in vitro diagnostic multivariate index assay cleared by the FDA.

The FDA announced today that a test to aid health care professionals in determining the origin of uncertain tumors has been cleared for marketing.

Using microarray technology, the Pathwork Tissue of Origin test measures gene expression patterns — which include more than 1,500 genes — and compares them with a database of 15 known tumor types to determine the tumor’s origin, according to a company press release. These tumor types represent 60 morphologies.

The test, marketed by Pathwork Diagnostics Inc., is the second in vitro diagnostic multivariate index assay that the FDA has cleared.

A clinical validation study that the company submitted to the FDA included 545 metastatic, poorly differentiated and undifferentiated tumors identified as one of the 15 known tumor types using existing methods. The test demonstrated 89% positive agreement (sensitivity) with available diagnoses and 99% negative agreement (specificity), according to the press release.

In a separate cross-laboratory comparison study published in the Journal of Molecular Diagnostics, researchers analyzed 60 metastatic, poorly differentiated and undifferentiated tissue specimens at four U.S. laboratories. The Pathwork Tissue of Origin test showed an average of 94% overall concordance.

J Mol Diagn. 2008;doi:10.2353/jmoldx.2008.070099.