The New York State Department of Health has issued Pathwork Diagnostics Inc a clinical laboratory permit and approved the offering of the company’s Tissue of Origin testing service to New York State residents. The Pathwork Tissue of Origin Test helps identify the origin of challenging tumors and increases pathologists’ and oncologists’ confidence in the cancer diagnosis. The permit 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. When a tumor’s tissue of origin cannot be identified with existing approaches such as imaging studies and immunohistochemistry, patients may not receive the most appropriate tumor-specific, standard-of-care treatment.
“When standard methodologies may not be sufficient to provide a definitive diagnosis, pathologists can consider using molecular profiling—using a tumor’s own genomic information—to help determine what type of cancer cells are present in a malignant tumor,” explained pathologist Ashraf Elnawawi, MD, PhD, The Brooklyn Hospital Center.
“Uncertainty about the identity or origin of the tumor makes diagnosis and treatment much more difficult,” commented oncologist Howard W. Bruckner, MD, director of medical oncology, New York Downtown Hospital. “The information provided by the Pathwork Tissue of Origin Test can be evaluated by the physician in the context of the patient’s clinical history and complementary diagnostics.”
Requiring very small amounts of formalin-fixed, paraffin-embedded (FFPE) tumor tissue, the Tissue of Origin Test measures the gene expression levels of more than 2,000 genes and provides an objective and accurate result for the tissue of origin.
The Tissue of Origin Test received FDA clearance earlier this year for use with FFPE tissues. It is the only FDA-cleared molecular diagnostic test for tissue of origin and the most rigorously validated test of its kind.
Source: Pathwork Diagnostics Inc