Pathwork Diagnostics, Sunnyvale, Calif,  a genomics-based diagnostics company focused on oncology, announced that Virginia Commonwealth University(VCU) School of Medicine has initiated an investigational study of the Pathwork Tissue of Origin Test. The new genomics-based test is designed to help determine a tumor’s origin so that tissue-specific management can begin. This makes VCU one of the first institutions in the country to evaluate this leading technology in patients who may have few remaining diagnostic options. The test was also the focus of two workshops and two poster presentations at the annual meeting of the Association for Molecular Pathology last week in Los Angeles.
 
“Patient cases in which a tumor cannot be readily identified are a significant problem,” said Catherine Dumur, PhD, director of molecular morphology genomics for the department of pathology, VCU. “Such cases are time consuming for physicians and anxiety producing for patients, and are a challenge to providing the most appropriate care for the patient. We are eager to see how this investigational new genomics-based test extends and complements traditional histopathological approaches.”
 
There are an estimated 200,000 cancer patients each year in the United States who may benefit from additional diagnostic information to determine the tissue of origin for their cancer. National Comprehensive Cancer Network guidelines emphasize the importance of identifying the tissue of origin so that management specific to the primary cancer can begin.
 
“We envision that in the future genomics data will become a useful ancillary tool to pathologists to answer complex cancer questions in a clinical setting,” said Carleton Garrett, MD, PhD, director of the Tissue and Data Acquisition and Analysis Core at VCU.
 
The test’s proprietary analytics are designed to measure the expression of more than 1600 genes and compare a tumor’s genetic “signature” against those of 15 known tissue types. The test uses microarray technology, which enables large numbers of genes to be evaluated at the same time, using the proven, commercially available Affymetrix instrument system. Until now, microarrays have been used primarily as research tools but presented challenges for use in clinical settings.
 
“Our unique processes have enabled us to overcome the challenges of applying microarray technology for clinical use and develop clinically useful diagnostic tests using microarray-based data,” explained Deborah J. Neff, Pathwork president and CEO. “The microarray is a great platform because we can look at so many pieces of information simultaneously.”
 
The Pathwork Tissue of Origin Test is not cleared by the FDA for sale in the US. It is for investigational use only.

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