NEW YORK (GenomeWeb News) – Pathwork Diagnostics today announced it has received approval from the New York State Department of Health to offer its Tissue of Origin testing service.
As a result the Redwood, Calif., company will be able to offer the service, which it said is the only FDA-cleared tissue of origin testing service in New York state.
The test helps identify the origin of challenging tumors and increases pathologist and oncologist confidence in the diagnosis of cancer, according to Pathwork. The test uses small amounts of formalin fixed, paraffin-embedded tumor tissue and measures gene expression levels of more than 2,000 genes. It received FDA clearance in June for use with FFPE tissues and is the only FDA-cleared molecular diagnostic test for tissue of origin.