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Diagnostics In Brief

This article was originally published in The Gray Sheet

Executive Summary

Pathwork tumor test: Molecular diagnostic firm receives FDA clearance July 29 for its Pathwork Tissue of Origin Test, used to determine the origin of hard-to-identify tumors. The test uses an Affymetrix microarray, cleared along with the tumor test, to measure the uncertain tumor's gene expression pattern and compare it to a panel of 15 known tumor types, including bladder, breast and colorectal. Pathwork is finalizing details to make the IVD kit available later this year; the test is already available as a service through the firm's lab. The test is the second in vitro diagnostic multivariate index assay (IVDMIA) cleared by FDA, after Agendia's MammaPrint breast cancer recurrence test
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