Metamark has for the first time, presented results the clinical validation study that showed ProMarkô, the first proteomic-based imaging biopsy test. ProMarkô was shown to predict which patients have low-risk disease with a sensitivity of 90 percent or better, confidently identifying patients who are appropriate for active surveillance or need aggressive therapy. The data is being presented at the 2014 Annual Meeting of the American Society of Clinical Oncology (ASCO).
"These results reinforce ProMarkô as a critical tool that has the potential to improve prostate cancer care by fulfilling the unmet need for more precise prognostic testing, which may benefit a significant number of the more than 200,000 men in the U.S. diagnosed annually who may be appropriate for active surveillance," said Fred Saad, M.D., F.R.C.S., Professor and Chief, Division of Urology, Director of Urologic Oncology, University of Montreal Hospital Center. "ProMarkô offers the oncology healthcare community a novel prognostic option to help confidently differentiate patients with more aggressive cancers from those with less aggressive disease, thereby enabling more personalized treatment decisions for our patients."
The results being presented are a culmination of three clinical studies. The first study identified 12 biomarkers that predicted both lethal outcome and prostate cancer pathology, and of those, eight were targeted in a clinical development biopsy study as the final subset for the ProMarkô test.
Researchers found that patients with low-risk ProMarkô scores (<0.33) were accurately identified as having favorable disease 81 percent of the time, with 90 percent specificity, while high-risk scores (>0.8) indicating non-favorable disease were predicted 77 percent of the time. Importantly, the ProMarkô test was found to provide additional, independent prediction relative to standard risk-stratification systems, including National Comprehensive Cancer Network (NCCN) guidelines, the D'Amico system, and CAPRA, all using Prostate-Specific Antigen (PSA) levels, Gleason grades and T stage to group men as low, intermediate, or high-risk.
"A key challenge in treating men with prostate cancer is determining whether they need aggressive therapy, or if active surveillance is appropriate. Current clinical and pathological parameters are insufficient in predicting the risk of aggressive cancer for early stage cancer patients" said Peter Blume-Jensen, M.D., Ph.D., Senior Vice President and Chief Scientific Officer at Metamark. "ProMarkô was developed with the specific purpose to address this need. This latest data is a significant milestone for Metamark as it indicates ProMarkô can be used as an objective aid in decision making together with standard-of-care for prostate cancer prognosis, and thereby help maintain a higher quality of life for patients by avoiding unnecessary aggressive therapy, like surgical prostatectomy or radiation."