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FDA Clears Pathwork Diagnostics' Test for FFPE

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Pathwork Diagnostics today said it has received clearance from the US Food and Drug Administration for its Tissue of Origin test for formalin-fixed paraffin embedded tissue.

The Pathwork Tissue of Origin test can now be broadly used on common clinical FFPE tumor specimens from both community and research hospitals, Pathwork Diagnostics said in a statement. The clearance also clears the way for additional FFPE-based cancer tests on its platform, the company added.

The test uses microarray-based RNA profiling to measure similarities between a patient's RNA expression patterns and the expression patterns in a database of 15 tumor types — such as metastatic, poorly differentiated, and undifferentiated cases — that were diagnosed according to the current clinical and pathological practice. Using microarray technology from Affymetrix, the Pathwork Tissue of Origin test measures expression levels of more than 2,000 genes, the company said.

Pathwork launched the FFPE test in January 2009 and will now move it from a laboratory-developed test to an in vitro diagnostic, and plans on making an IVD kit available to customers who want to use the test in their own labs.

The original version of the test, which was not for FFPE samples, was cleared by the FDA in July 2008, which made it the second in vitro diagnostic multivariate index assay to receive clearance from the regulatory agency.

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