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New Releases: Jan 14, 2009

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Pathwork Diagnostics this week launched a new version of its Tissue-of-Origin test to gauge cancer type that can analyze formalin-fixed, paraffin-embedded tissue specimens.

The company received clearance from the US Food and Drug Administration for the first version of the so-called Tissue-of-Origin test. The second version is a laboratory-developed test available through Pathwork's CLIA lab.

“The capability to work with FFPE specimens will enable our test to be more broadly utilized by oncologists and pathologists,” Pathwork CEO Deborah Neff said in a statement.

According to the company, its Tissue of Origin Test uses Affymetrix microarray technology to measure gene expression patterns in a tumor of unknown origin and compares it to expression patterns of more than 1,500 genes in 15 tumor types representing 90 percent of all solid tumor and 58 morphologies.

In the clinical validation study of 352 metastatic, poorly differentiated and undifferentiated tumors utilizing FFPE tumor specimens, the new test demonstrated 89 percent positive percent agreement, which is akin to sensitivity, with available diagnoses and greater than 99 percent negative percent agreement, which is similar to specificity, the company reported.

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