The Pathwork Tissue of Origin Test is the only FDA-cleared, Medicare-covered molecular diagnostic for identifying tissue of origin. It uses a tumor’s own genomic information to help pathologists and oncologists diagnose challenging cancer cases such as those that are metastatic or that have a complex clinical history.
“The Tissue of Origin Test significantly altered clinical practice patterns for treating metastatic cancer,” explained John Hornberger, M.D., M.S., CEO/President of Cedar Associates LLC and Principal Investigator of the study. “We saw an increase in overall survival and quality-adjusted life years, resulting in an expected cost per QALY of less than $50,000 per patient, which is within the generally accepted threshold of <$100,000 for cost-effectiveness in the United States.”1,2
The Pathwork Tissue of Origin Test, available through the Pathwork Diagnostics Laboratory, measures gene expression levels of 2,000 genes and uses proprietary algorithms to compare the tumor’s gene expression pattern to that of 15 tumor types, representing 58 morphologies and 90% of all solid tumors. The test provides objective genomic information to help the physician diagnose what type of cancer the patient has. An accurate diagnosis allows oncologists to match therapy to the cancer.
The Pathwork Tissue of Origin Test has been extensively evaluated in multiple independent studies involving more than 1,100 patient specimens, including large validation studies published in the Journal of Clinical Oncology and the Journal of Molecular Diagnostics.
A retrospective study of 111 cases from 66 academic and community oncology practices illustrates the use of the test in management of cancer patients. Over two thirds of the cases reviewed showed cancer management changed after the Pathwork Tissue of Origin Test result was received. The majority of the oncologists identified the Tissue of Origin Test results as influencing the decision to make a change in therapy.
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