The days of “Carcinoma of Unknown Primary Origin” diagnoses are coming to an end. The Food and Drug Administration has just announced clearance for marketing of a new genetic test, dubbed Pathwork Tissue of Origin test, from Pathwork Diagnostics, Inc., a Sunnyvale, CA firm. The test is based on a microarray technology to analyze thousands of pieces of genetic material from a cancer sample, which can provide an estimate on the origin of hard-to-identify tumor specimens. The company says that the “test measures the expression pattern, comprising more than 1,500 genes, in an uncertain tumor to compare it to expression patterns of a panel of 15 known tumor types, representing 60 morphologies overall, and provides a comprehensive report..”
The FDA explains:
The Pathwork Tissue of Origin test compares the genetic material of a patient’s tumor with genetic information on malignant tumor types stored in a database.
It uses a microarray technology to analyze thousands of pieces of genetic material at one time. The test considers 15 common malignant tumor types, including bladder, breast, and colorectal tumors.
“The clearance of the Pathwork test is another step in the continued integration of molecular-based medicine into standard practice,” said Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health, which oversees medical diagnostics. “In the past, scientists have classified different types of cancers based on the organs in which the tumors develop. With the help of microarray technology, they will be able to classify these types of cancers in a standardized non-reader dependent manner based on the patterns of gene activity in the tumor cells…”
Pathwork’s proprietary software converts the scanned image data to gene expression measurements. The gene expression patterns are compared with known gene expression patterns in the database that correspond to different tumor types.
The Pathwork Tissue of Origin test has been found to provide patterns that confirm existing tissue of origin of the 15 common tumor types using standard clinical and pathological information. This accuracy of this test is similar to that achieved by expert pathologists using current standards of practice.
To learn more about the test, head on to the product page: The Pathwork® Tissue of Origin Test…
Press release: FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample…