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.
In the study, use of chemotherapy regimens consistent with guidelines for the final tumor-site diagnosis increased significantly from 42% to 65%, a gain of 23%. Overall survival was projected to increase from 15.9 months to 19.5 months, a mean gain of 3.6 months overall survival. The average increase in survival adjusted for quality of life was 2.7 months and the average cost per quality-adjusted life year (QALY) gained was $46,858.
“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.”
The retrospective, observational study examined treatment changes made in patients by physicians who received Tissue of Origin Test results. Changes in planned chemotherapy, surgery, radiation therapy, blood tests, imaging and referral to hospice care before and after test results were recorded. Estimates of the effect of changes in chemotherapy on survival were based on National Comprehensive Cancer Network (NCCN) and other treatment guidelines. Costs were estimated based on data from NCCN and Centers for Medicare and Medicaid Services (CMS) fee schedules. Changes in overall survival, costs, and cost per quality-adjusted life year (QALY) gained were estimated.
QALY is a measure used in cost-utility analysis. It estimates the dollar value of a medical intervention, based on the number of years of life that would be added by the intervention, taking into account both the quality and the quantity of life lived.