Pathwork First to Net FDA OK for CUP Dx | GenomeWeb

By being the first to launch an FDA- and CLIA-approved test designed to help physicians determine cancer type in a tumor, Pathwork Diagnostics may have gained a significant advantage over competitors.

This summer, Pathwork received 510(k) clearance from the FDA for its Tissue of Origin test.

The test, which uses Pathwork's PathChip microarray and runs on Affymetrix's GeneChip platform, "is the first custom Affymetrix gene expression array to be cleared for diagnostic use," the FDA noted in a statement.

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