Lab Test for Hard-to-Identify Tumors Launched
The new Pathwork Tissue of Origin Test was unveiled (pdf) by Pathwork Diagnostics, Incorporated. The test is available through the company’s in-house CLIA-certified Pathwork Diagnostics Laboratory. The company posted news of the test launch on their website.
The test is designed to assist with the diagnosis of tumors with an uncertain origin. This is one of the first commercially available microarray-based diagnostic tests for cancer in this country. It is suggested that microarray testing will significantly increase the likelihood that primary tumor site can be identified correctly.
The tool measures the expression of more than 1,500 genes. This is then developed into a gene expression profile of the patient’s tumor, which is then compared to the profiles of 15 known tissues. The test provides an objective, probability-based score for each type of tissue.
The Pathchip microarray system is a key component of the test. Also incorporated is the Affymetrix GeneChip System. Affymetrix, a partner with Pathwork Diagnostics, provides an array of tools to support development of complex biomarker signatures assay.
A study completed in the Pathwork’s lab assessed 487 metastatic poorly differentiated and undifferentiated tumors. Sensitivity of the test was documented at 89 percent and 99 percent specificity when compared to specimen identification based on current methodologies.
The company is also working to procure approval from the FDA for marketing clearance of the Tissue of Origin Test. This is a noted gap in the diagnostic process for oncologists. There are more than 200,000 patients each year in the U.S. who have tumors of unknown origin.
Currently, a variety of imaging methods and pathologic assessment is employed to identify tissue. Oftentimes, these approaches are unsuccessful. The inability to identify tumor type prevents the development of the appropriate cancer-specific treatment regimen for an individual patient.
April 23, 2008 Related topics: Laboratory, Product Launches, New Technology & Innovation, Diagnostic, Hematology & Oncology