The Pathwork Tissue of Origin Test helps to identify the origin of tumors and increases pathologists’ and oncologists’ confidence in the cancer diagnosis.
Pathwork said the permission establishes the test as the only FDA-cleared tissue of origin testing service available in New York State.
The gene expression-based Pathwork Tissue of Origin Test assists in accurately and reliably identifying the origin of metastatic or poorly differentiated tumors, the company said.
The Tissue of Origin Test requires very small amounts of formalin-fixed, paraffin-embedded (FFPE) tumor tissue and measures the gene expression levels of more than 2,000 genes and provides an objective and accurate result for the tissue of origin.
Pathwork Diagnostics CEO Deborah Neff said the Pathwork Tissue of Origin Test has been adopted by leading oncologists and pathologists at major academic medical centers and top cancer clinics across the US.
"Obtaining the New York State Clinical Laboratory Permit reflects the exceptional performance and the robust science underlying the test," Neff said.
The Tissue of Origin Test received FDA clearance for use with FFPE tissues, the only FDA-cleared molecular diagnostic test for tissue of origin and the most validated test of its kind.
