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Pathwork(R) Diagnostics Launches Genomics-Based Test For Hard-To-Identify Tumors Through Its CLIA-Certified Laboratory
Date:4/22/2008

The Pathwork(R) Tissue of Origin Test Aids in the Diagnosis of Uncertain

Tumors

SUNNYVALE, Calif., April 22 /PRNewswire/ -- Pathwork Diagnostics, Inc., a genomics-based diagnostics company focused on oncology, today announced the launch of the Pathwork Tissue of Origin Test through its CLIA-certified Pathwork(R) Diagnostics Laboratory. The 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 Pathwork Tissue of Origin Test uses the power of genomic information to provide diagnostic answers that help physicians make clinical decisions with more certainty. Ultimately, we believe our test will improve patient outcomes while saving the healthcare system money," said Deborah J. Neff, president and chief executive officer 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 FDA to obtain product clearance, so that we can offer a diagnostic kit directly to clinical laboratories at major medical centers."

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 an objective, probability-based score for each potential tissue. The test uses a proprietary Pathchip(TM) microarray and runs on the proven Affymetrix GeneChip(R) System. In a Pathwork Diagnostics Laboratory clinical validation study of 487 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.(1)

"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. "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 U.S. each year. Knowing the primary tumor site with greater certainty enables the oncologist to select cancer-specific therapy according to National Comprehensive Cancer Network guidelines.

"Traditional tools used to identify tumors of uncertain origin include imaging, such as CT scans and MRIs, as well as thorough pathological evaluation with immunohistochemistry and other techniques," said Federico A. Monzon, M.D., pathologist and director of molecular diagnostics at The Methodist Hospital and The Methodist Hospital Research Institute in Houston. "However, these techniques do not identify a tissue of origin in a significant number of cases. Microarray-based gene expression testing offers strong potential to fill this void and improve the diagnosis of uncertain primary tumors."

"Affymetrix is the leader in offering a continuous path to discover, develop and commercialize complex biomarker signature assays," said Kevin King, president of Affymetrix. "Our platform enables partners like Pathwork Diagnostics to create more efficient and complete methods to better diagnose, classify and manage complex diseases. The Pathwork Tissue of Origin Test is a great example of an array-based diagnostic test that is helping to make personalized medicine a reality - today."

Oncologists and pathologists may provide qualified frozen tissue specimens to the Pathwork Diagnostics Laboratory, located in Sunnyvale, California, for processing and analysis using the Pathwork Tissue of Origin Test. A Pathwork staff pathologist interprets the results and provides a comprehensive report to the ordering physician. Pathwork Diagnostics Laboratory is currently licensed to accept samples from 45 states and is actively working to obtain licensing from the remaining five states (N.Y., Fla., Pa., R.I. and Md.). The company is also currently developing a test for formalin-fixed, paraffin- embedded (FFPE) tissue specimens, which is expected to be available later this year.

About Pathwork Diagnostics

Pathwork Diagnostics, Inc., 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(TM) microarray, which runs on the proven Affymetrix GeneChip(R) platform. 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 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) 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


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SOURCE Pathwork Diagnostics, Inc.
Copyright©2008 PR Newswire.
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