NEW YORK (GenomeWeb News) – Pathwork Diagnostics today said that Guy’s and St. Thomas’ NHS Foundation Trust in London will be the first UK hospitals to conduct validation studies on Pathwork Diagnostics’ Tissue of Origin test.
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The test uses a microarray to measure the RNA expression pattern of a tumor and compare it to a panel of 15 known tumor types, representing 60 morphologies overall, to help the determine the tumor’s origin. It is based on Pathwork’s PathChip gene-expression array, which runs on Affymetrix’s GCS3000Dx diagnostic platform.
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This past summer, the US Food and Drug Administration cleared the test for marketing in the US. It was the second in vitro diagnostic multivariate index assay, or IVDMIA, device to be cleared by the FDA, following Agendia’s MammaPrint test, which the agency approved in February 2007.
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"In this study, pathologists and oncologists at Guy's and St Thomas' will not only be able to validate the test for use in their institution, but more importantly, soon be able to use information generated to help them determine the most effective, cancer-specific treatment regimen for hard-to-diagnose cases," said Pathwork President and CEO Deborah Neff in a statement.
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Further terms of the collaboration were not disclosed.