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Data Presented at Cancer Molecular Markers Meeting Suggests Clinical Benefit for Integrating New Molecular Tests
Date:10/31/2008

inistration's (FDA) new IVDMIA (In Vitro Diagnostic Multivariate Index Assays) guidelines. In the clinical validation study submitted to the FDA, the test demonstrated 89 percent positive agreement (akin to sensitivity) and 99 percent negative agreement (akin to specificity) with available diagnoses of 545 metastatic, poorly differentiated and undifferentiated tumors. All 545 specimens included one of the 15 tissues on the test panel.

About Pathwork Diagnostics

Pathwork Diagnostics, Inc., based in Sunnyvale, Calif., develops and commercializes high-value molecular diagnostics for oncology. The company's first test to market - the Pathwork(R) Tissue of Origin Test - utilizes proprietary analytics and a companion Pathchip(R) microarray, which runs on the proven Affymetrix GeneChip(R) System. The test aids in determining a hard-to-identify tumor's origin so that standard-of-care, cancer-specific treatment can begin. The test is FDA-cleared as an in vitro diagnostic kit, while a functionally equivalent version of the test is also available through the CLIA-certified Pathwork(R) Diagnostics Laboratory. For more information, call 1.877.808.0006 or visit http://www.pathworkdx.com.

(C)2008 Pathwork Diagnostics, Inc. All rights reserved. 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.

CONTACT: Scott Shadiow

415.515.0786

media@pathworkdx.com


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SOURCE Pathwork Diagnostics
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