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Virginia Commonwealth University to Study Genomics-Based Diagnostic Test:

Pathwork Diagnostics' Tissue of Origin Test Designed to Aid in

Determination of a Tumor's Origin

SUNNYVALE, Calif., Nov. 6 /PRNewswire/ -- Pathwork Diagnostics, a genomics-based diagnostics company focused on oncology, announced today that Virginia Commonwealth University School of Medicine has initiated an investigational study of the Pathwork(TM) 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. VCU's study makes it one of the first institutions in the country to evaluate this leading technology in patients who may have few remaining diagnostic options. The Tissue of Origin Test is also the focus of two workshops and two poster presentations at the 12th Annual Meeting of the Association for Molecular Pathology this week (November 7-10, Los Angeles).

"Patient cases in which a tumor cannot be readily identified are a significant problem," said Catherine Dumur, Ph.D., 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, M.D. Ph.D., Director of the Tissue and Data Acquisition and Analysis Core at VCU. "Virginia Commonwealth University will continue to evaluate the use of such innovative technologies in order to ensure that our cancer patients continue to receive the best possible care."

The Pathwork Tissue of Origin 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. Up 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 Pathwork President and C.E.O. Deborah J. Neff. "The microarray is a great platform because we can look at so many pieces of information simultaneously."

Note: The Pathwork Tissue of Origin Test is not cleared by the FDA for sale in the U.S. It is for Investigational Use Only.

Association for Molecular Pathology (AMP) Annual Meeting

At this week's 12th Annual Meeting of the Association for Molecular Pathology, Pathwork Diagnostics will host a corporate workshop, "Diagnostic System to Identify the Tissue of Origin in Poorly Differentiated or Undifferentiated Cancers Using Gene Expression," presented by Federico Monzon, M.D., Methodist Hospital, Houston, TX; and Iris Schrijver, M.D., Stanford University, Stanford, CA (Wednesday, November 7, 4-5 PM, Santa Monica Room).

A second Pathwork Diagnostics workshop, "Designing for IVDMIA, Gene Expression Profiling and Molecular Oncology," will take place as part of the Affymetrix Corporate Workshop. It will be presented by C. Ted Rigl, Ph.D., V.P. Product Development at Pathwork Diagnostics (Wednesday, November 7, 10 AM to noon, Olympic A Room).

The Tissue of Origin Test is the focus of two poster presentations at the meeting: "Analytic performance of a microarray-based gene expression test to determine tissue of origin in uncertain primary cancers" will be presented by Catherine I. Dumur, Ph.D., Virginia Commonwealth University, Richmond, VA (#ST01, Thursday, November 8, 2:30-4:30 PM, Constellation and Olympic Ballroom).

"Validation of a gene expression-based tissue of origin test applied to poorly differentiated and undifferentiated cancers" will be presented by Federico Monzon, M.D., Methodist Hospital, Houston, TX (#ST102, Friday, November 9, 1:00-3:00 PM, Constellation and Olympic Ballroom).

About VCU and the VCU Medical Center

Virginia Commonwealth University is the largest university in Virginia and ranks among the top 100 universities in the country in sponsored research. Located on two downtown campuses in Richmond, VCU enrolls more than 31,000 students in nearly 200 certificate and degree programs in the arts, sciences and humanities. Sixty-three of the programs are unique in Virginia, many of them crossing the disciplines of VCU's 15 schools and one college. MCV Hospitals and the health sciences schools of Virginia Commonwealth University compose the VCU Medical Center, one of the nation's leading academic medical centers. For more, see

About Pathwork Diagnostics

Pathwork Diagnostics, based in Sunnyvale, California, develops and delivers genomics-based diagnostics that advance cancer care. The company solves unmet clinical needs in oncology by using innovative technology to harness the power of genomics information and apply it in a robust, reproducible and reliable manner. Pathwork Diagnostics plans to deliver FDA-cleared microarray-based diagnostic tests for oncology to the clinical laboratory. The company's initial tests will consist of Pathwork Diagnostics' proprietary analytics and a companion Pathchip(TM) microarray, which runs on the proven Affymetrix instrument system. The company's first test -- the Pathwork(TM) Tissue of Origin Test -- is designed to be an aid in the diagnosis of the tissue of origin in patients with undifferentiated or poorly differentiated tumors or metastases.

SOURCE Pathwork Diagnostics
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