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

, genomic diagnostic tests can establish an appropriate place in the practice of evidence-based medicine."

"While it is important to note that tissue identification in the clinical setting utilizes clinical information in addition to IHC results, such as biopsy site, patient gender, age, clinical history and imaging techniques, the results of this analysis clearly demonstrate the opportunity for the Pathwork(R) Tissue of Origin Test to complement IHC in the clinic," said Deborah J. Neff, President and Chief Executive Officer of Pathwork Diagnostics.

About the Study

A literature search was conducted to identify all studies published since 1990 designed to quantify IHC performance in tissue determination. Five studies met the pre-defined criteria; more than 50 appropriately masked specimens and including more than three tissue types. These studies evaluated the successful identification from among three to seven different tissue types using a panel of seven to 10 different IHC tests. Data from the five studies were separated into two subgroups: metastatic tumors only (n=368 specimens), and blended studies that combined primary tumors and metastases (n=298 specimens). The meta-analysis found that IHC tests provided the correct tissue identification for 82.3% of the blended primary and metastatic samples and 65.6% of metastatic cancers, confirming the clinical need for improved diagnostic methods in tissue of origin determination.

About the Pathwork Tissue of Origin Test

The Pathwork Tissue of Origin Test uses a microarray to measure the expression pattern, comprising more than 1,500 genes, in the tumor and compares it to expression patterns of a panel of 15 known tumor types, representing 60 morphologies overall, to help determine the tumor's origin. Earlier this year, the test received FDA clearance, making Pathwork the first company of U.S. origin to receive clearance for a molecular diagnostics test under the U.S. Food and Drug Adm
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SOURCE Pathwork Diagnostics
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