Genomics-Based Test Launched for Hard-to-Identify Tumors

A new test aids in the diagnosis of tumors of uncertain origin and is among the first microarray-based diagnostic tests for cancer available in the United States.

The tissue of origin test measures the expression of more than 1,500 genes to compare a tumor's gene expression profile to those of 15 known tissues, representing more than 60 morphologies, and to provide an objective, probability-based score for each potential tissue.

Pathwork Diagnostics, Inc. (Sunnyvale, CA, USA), a genomics-based diagnostics company focused on oncology, launched the Pathwork Tissue of Origin test through its Clinical Laboratory Improvement Amendments (CLIA)-certified Pathwork Diagnostics Laboratory. The test uses a proprietary Pathchip microarray and runs on the Affymetrix (Santa Clara, CA, USA) GeneChip system.

In a Pathwork Diagnostics Laboratory a clinical validation study of 487 metastatic, poorly differentiated, and undifferentiated tumors, which had already been identified using current methodologies, the test demonstrated a sensitivity of 89% and a specificity of 99%.

"Ultimately, we believe our test will improve patient outcomes while saving the healthcare system money,” said Deborah J. Neff, president and CEO of Pathwork Diagnostics. "We are making our test available through our clinical laboratory due to strong interest from leading oncologists and pathologists. We are also working actively with the [US Food and Drug Administration] FDA (Rockville, MD, USA) to obtain product clearance, so that we can offer a diagnostic kit directly to clinical laboratories at major medical centers.”

"Hard-to-identify tumors are a significant clinical problem,” said Divyesh D. Mehta, M.D., director of clinical oncology at the University of Illinois at Chicago Medical Center (Chicago, IL, USA). "They are time-consuming, expensive, and frustrating for both physicians and patients, and prevent cancer-specific treatment guidelines from being followed.”

There are an estimated 200,000 patients with uncertain primary tumors, including cancer of unknown primary, in the United States each year. Knowing the primary tumor site with greater certainty will enable the oncologist to select cancer-specific therapy according to National Comprehensive Cancer Network guidelines.


Related Links:
Pathwork Diagnostics
Affymetrix
US Food and Drug Administration