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Pathwork(R) Diagnostics Launches Genomics-Based Test For Hard-To-Identify Tumors Through Its CLIA-Certified Laboratory

Wednesday, April 23, 2008 General News J E 4
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SUNNYVALE, Calif., April 22 Pathwork Diagnostics, Inc., agenomics-based diagnostics company focused on oncology, today announced thelaunch of the Pathwork Tissue of Origin Test through its CLIA-certifiedPathwork(R) Diagnostics Laboratory. The new test aids in the diagnosis oftumors of uncertain origin and is among the first microarray-based diagnostictests for cancer available in the United States.

"The Pathwork Tissue of Origin Test uses the power of genomic informationto provide diagnostic answers that help physicians make clinical decisionswith more certainty. Ultimately, we believe our test will improve patientoutcomes while saving the healthcare system money," said Deborah J. Neff,president and chief executive officer of Pathwork Diagnostics. "We are makingour test available through our clinical laboratory due to strong interest fromleading oncologists and pathologists. We are also working actively with theFDA to obtain product clearance, so that we can offer a diagnostic kitdirectly to clinical laboratories at major medical centers."

The Pathwork Tissue of Origin Test measures the expression of more than1,500 genes to compare a tumor's gene expression profile to those of 15 knowntissues, representing more than 60 morphologies, and to provide an objective,probability-based score for each potential tissue. The test uses a proprietaryPathchip(TM) microarray and runs on the proven Affymetrix GeneChip(R) System.In a Pathwork Diagnostics Laboratory clinical validation study of 487metastatic and poorly differentiated and undifferentiated tumors, which hadalready been identified using current methodologies, the test demonstrated asensitivity of 89 percent and a specificity of 99 percent.(1)

"Hard-to-identify tumors are a significant clinical problem," said DivyeshD. Mehta, M.D., Director of Clinical Oncology at the University of Illinois atChicago Medical Center. "They are time-consuming, expensive and frustratingfor both physicians and patients, and prevent cancer-specific treatmentguidelines 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 theprimary tumor site with greater certainty enables the oncologist to selectcancer-specific therapy according to National Comprehensive Cancer Networkguidelines.

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

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

Oncologists and pathologists may provide qualified frozen tissue specimensto the Pathwork Diagnostics Laboratory, located in Sunnyvale, California, forprocessing and analysis using the Pathwork Tissue of Origin Test. A Pathworkstaff pathologist interprets the results and provides a comprehensive reportto the ordering physician. Pathwork Diagnostics Laboratory is currentlylicensed to accept samples from 45 states and is actively working to obtainlicens
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