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Stanford University to Study Genomics-Based Diagnostic Test for Uncertain Tumors

Posted on: Tuesday, 6 May 2008, 09:01 CDT

SUNNYVALE, Calif., May 6 /PRNewswire/ -- Pathwork Diagnostics, Inc., a molecular diagnostics company focused on oncology, announced today that Stanford University School of Medicine has initiated an investigational study of the Pathwork(R) Tissue of Origin Test. The new test uses advanced genomics-based technology to help physicians determine a tumor's origin in order to optimize cancer-specific treatment. The study will evaluate the test's ability to impact diagnosis for cancer patients with hard-to-identify tumors, with test samples processed at the Stanford University School of Medicine's laboratory.

"Hard-to-identify tumors are particularly challenging for physicians," said Dr. Iris Schrijver, Director of Molecular Pathology at Stanford University School of Medicine. "Clinical workups for these patients can be time-consuming, expensive and frustrating for both the physician and the patient, particularly when traditional diagnostic approaches are unable to provide answers. We are looking forward to evaluating the Tissue of Origin Test's potential to provide diagnostic answers that can help further guide patient care in these challenging cases."

"We are pleased that an institution of Stanford University School of Medicine's caliber is evaluating our test," said Deborah J. Neff, Pathwork Diagnostic's president and chief executive officer. "Our test is available as a service through our CLIA-certified laboratory so that physicians outside of Stanford University can have specimens processed and clinical results provided. Additionally, we are actively working to obtain FDA clearance so that we can offer a diagnostic kit directly to clinical laboratories at major medical centers."

Stanford University School of Medicine also participated in a cross-laboratory comparison study of the Pathwork Tissue of Origin Test, published in The Journal of Molecular Diagnostics. In that study of 60 metastatic and poorly differentiated and undifferentiated tissue specimens, the test demonstrated an average 94 percent overall concordance across four laboratories(1).

The Pathwork 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 a report with an objective, probability-based score for each potential tissue. This helps physicians rule in and rule out potential tissue types. The test uses a proprietary Pathchip(R) microarray and runs on the proven Affymetrix GeneChip(R) System. In a clinical validation study of 477 metastatic and poorly differentiated and undifferentiated tumors, which had already been identified using current methodologies, the test demonstrated a sensitivity of 89 percent and a specificity of 99 percent(2).

There are an estimated 200,000 patients with uncertain primary tumors, including Cancer of Unknown Primary, in the U.S. each year. Knowing the primary site of a metastatic tumor with greater certainty enables the oncologist to select cancer-specific therapy according to National Comprehensive Cancer Network guidelines.

About Stanford University Medical Center

Stanford University Medical Center integrates research, medical education and patient care at its three institutions -- Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children's Hospital. For more information, please visit the Office of Communication & Public Affairs site at http://mednews.stanford.edu/.

About Pathwork Diagnostics

Pathwork Diagnostics, based in Sunnyvale, California, develops and commercializes high-value molecular diagnostics for oncology. The company offers microarray-based tests through its CLIA-certified laboratory, and plans to provide FDA-cleared diagnostic test kits to clinical laboratories. The company's initial tests will utilize Pathwork Diagnostics' proprietary analytics and a companion Pathchip(R) microarray, which runs on the proven Affymetrix GeneChip(R) System. The company's first test -- the Pathwork Tissue of Origin Test -- is now available through Pathwork Diagnostics Laboratory and aids in determining a tissue's origin so that cancer-specific treatment can begin. The Pathwork Tissue of Origin Test is designed to improve patient care and save the healthcare system money by reducing the use of non-targeted, broad-based therapies, and their associated toxicities. For more information, please call 1-877-808-0006 or visit http://www.pathworkdx.com/.

(C) 2008 Pathwork Diagnostics, Inc. Pathwork, Pathchip, Pathwork Diagnostics, and the Pathwork Diagnostics logo are trademarks or registered trademarks of Pathwork Diagnostics, Inc. Other names may be the trademarks of their respective owners.

(1) Dumur CI, Lyons-Weiler M, Sciulli C, et al. J Mol Diagn. 2008;10:67-77 (2) Monzon FA, Dumur CI, Lyons-Weiler M, et al. Association for Molecular Pathology Annual Meeting, 2007; Abstract #ST02 CONTACT: Tracy Morris 650-473-1272 tracy@morrismarcom.com

Pathwork Diagnostics, Inc.

CONTACT: Tracy Morris, +1-650-473-1272, tracy@morrismarcom.com, forPathwork Diagnostics, Inc.

Web site: http://www.pathworkdx.com/http://mednews.stanford.edu/

Source: PRNewswire

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