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Pathwork's gene expression test for cancer cleared by FDA

This article was originally published in Clinica

Executive Summary

The US FDA has granted 510(k) approval for Pathwork Diagnostics' Tissue of Origin test for determining the origin of uncertain tumours. The diagnostic analyses a tumour's gene expression pattern and compares it with expression patterns of 15 known tumour types, including bladder, breast and colorectal. This enables more appropriate cancer treatments, especially with the advent of targeted therapies for particular tumour types like Herceptin for breast cancer. The test is the first of its kind to receive FDA clearance, Sunnyvale, California-based Pathwork claims. A 545-patient study showed 89% positive agreement (akin to sensitivity) and 99% negative agreement (akin to specificity). The test was previously available as a service through Pathwork's CLIA-certified laboratory.

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