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Independent Study of Pathwork Diagnostics Tissue of Origin Test at Virginia Commonwealth University Confirms Clinical  
12/15/2011 10:04:16 AM

Redwood City, CA, December 15, 2011 – Pathwork Diagnostics, Inc., a pioneer in creating genomics-based diagnostics in oncology utilizing their proprietary informatics platform, announced today results of a study conducted at Virginia Commonwealth University of the company’s Pathwork™ Tissue of Origin Test have been published online in the American Journal of Clinical Pathology.

The Pathwork Tissue of Origin Test is the only FDA-cleared, Medicare-covered molecular diagnostic for identifying tissue of origin. It uses a tumor's own genomic information to help pathologists and oncologists in the diagnosis of challenging cancer cases such as those that are metastatic or that have a complex clinical history.

In the study, the analytic and clinical performance of the Tissue of Origin Test was examined in 43 poorly differentiated and undifferentiated tumor samples. Results showed 97% (95% confidence interval, 80.4%-99.8%) agreement between the Tissue of Origin Test result and the reference diagnosis, which was determined on the basis of clinical correlations and immunohistochemical findings and was among the 15 tumor tissue types covered by the Tissue of Origin Test. This finding correlates well with the validated performance of the Tissue of Origin Test, 88.5% agreement with available diagnosis in 462 specimens (95% confidence interval, 85.3%-91.3%).

The study in the American Journal of Clinical Pathology, “Clinical verification of the performance of the Pathwork tissue of origin test: utility and limitations,” was conducted by Catherine Dumur, Ph.D., Director of Molecular Morphology Genomics for the Department of Pathology, Virginia Commonwealth University.

About the Pathwork Tissue of Origin Test

The Pathwork Tissue of Origin Test, available through the Pathwork Diagnostics Laboratory, measures gene expression levels of 2,000 genes and uses proprietary algorithms to compare the tumor’s gene expression pattern to that of 15 tumor types, representing 58 morphologies and 90% of all solid tumors. The test provides objective genomic information to help the physician diagnose what type of cancer the patient has. An accurate diagnosis allows oncologists to match therapy to the cancer.

The Pathwork Tissue of Origin Test has been extensively evaluated in multiple independent studies involving more than 1,100 patient specimens, including large validation studies published in the Journal of Clinical Oncology and the Journal of Molecular Diagnostics.

A retrospective study of 111 cases from 66 academic and community oncology practices illustrates the use of the test in management of cancer patients. Over two thirds of the cases reviewed showed cancer management changed after the Pathwork Tissue of Origin Test result was received. The majority of the oncologists identified the Tissue of Origin Test results as influencing the decision to make a change in therapy.

About Pathwork Diagnostics

Pathwork Diagnostics created its proprietary informatics platform to develop and commercialize high-value, medically important diagnostics aimed at helping guide cancer care. Pathwork has commercialized its Pathwork Tissue of Origin product line, and has a robust pipeline and growing portfolio of pharmaceutical partners. Pathwork is privately held and based in Redwood City, CA. For more information call toll-free (877) 808-0006 or visit www.pathworkdx.com