Metamark Genetics, Inc. Release: Study Demonstrates Cost-Effectiveness Of New Assay To Inform Treatment Decisions Compared To Guidelines-Based Care

Data published in The Oncologist support use of ProMark^® as a likely cost-effective addition to current guidelines for management of Gleason 3+3 and 3+4 early-stage prostate cancer

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Metamark Genetics, Inc. (“Metamark” or the “Company”), a leader in commercializing high-value urologic oncology products, today announced that a study published in The Oncologist demonstrates that use of its novel proteomic prognostic test ProMark^®, for early-stage prostate cancer, is likely to result in more cost-effective care than the National Comprehensive Cancer Network’s (NCCN) risk classification guidelines alone. Findings provide important new evidence about the use of a biopsy-based 8-protein prostate cancer prognostic assay like ProMark^® to optimize treatment decision-making in patients with Gleason 3+3 and 3+4 early-stage prostate cancer.

“Aggressive treatments can have serious side effects, including urinary, bowel, and erectile dysfunction. These data support the use of ProMark® as a critical tool in helping to inform urologists and their patients, thereby facilitating their ability to choose among competing treatment options.”

“Not all prostate cancers require aggressive treatment. On the contrary, the majority of prostate cancer cases involve indolent—or slow growing—tumors that are associated with little risk to a man’s health or longevity,” said Dr. Jerome P. Richie, chief medical officer at Metamark. “Aggressive treatments can have serious side effects, including urinary, bowel, and erectile dysfunction. These data support the use of ProMark^® as a critical tool in helping to inform urologists and their patients, thereby facilitating their ability to choose among competing treatment options.”

Risk classification guidelines for prostate cancer care, such as those published by the NCCN, have been imperative since, until recently, urologists have not had molecular tools that are sophisticated enough to distinguish between aggressive and indolent tumors, or to stratify patients for active surveillance versus therapeutic intervention. Unfortunately, many patients with Gleason 3+3 and 3+4 early-stage prostate cancer receive aggressive treatment, but likely derive little to no benefitⁱ. Clinical studies show that ProMark^® is a well-validated, relevant molecular tool for making informed decisions in prostate care, allowing men to potentially avoid the burden of aggressive treatment by impacting how risk is classifiedⁱⁱ. Data published in The Oncologist support that treatment paths following use of a prognostic test like ProMark^® can be more cost-effective and result in better quality of life compared to care resulting from current risk classification alone, by helping to more accurately identify patients eligible for active surveillance following biopsy.

“Our study found that the 8-protein assay strategy has the potential to dominate the current standard of care approach, meaning that it can improve patient outcomes and reduce costs, even after accounting for the costs of additional testing and monitoring,” said Josh Carlson, study lead, partner at Veritech Inc., and assistant professor in the Pharmaceutical Outcomes Research and Policy Program at the University of Washington. “The ProMark^® assay was projected to be more effective in shifting low-risk patients toward active surveillance, and away from aggressive treatment than usual care based on NCCN risk classification alone.”

ProMark^® is the first 8-protein prostate cancer prognostic assay that generates a risk score at time of biopsy that is predictive of prostate cancer aggressiveness and can inform treatment decisions.

The full publication of the independent research, supported through funding from Metamark and conducted by professors in the Department of Pharmacy at the Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, University of Washington, can be found here.

Study Design
This study was conducted with a simulation model to estimate quality-adjusted life-year (QALY) and cost outcomes for ProMark^® and usual care (NCCN guidelines) strategies. Risk classification outcomes, treatment distributions, costs, health state utilities, and mortality rates were derived from the ProMark^® assay’s validation study, and the peer-reviewed literature. Outcomes included incremental QALYs, costs, and cost-effectiveness ratios. One-way and probabilistic sensitivity analyses (PSA) were conducted to evaluate the most influential inputs and explore joint uncertainty in outcomes, respectively. Based on the analysis, ProMark^® decreased cost and increased QALY in 86.9% and 58.3% of simulations, respectively.

About ProMark^®
Launched in late 2014, ProMark^® is the first proteomic classifier of biopsied prostate tissue to assess whether an early-stage prostate tumor is aggressive or indolent. Test results generated in Metamark’s Cambridge, Mass. CLIA-certified laboratory can aid the decision whether to treat the cancer aggressively or to choose a course of active surveillance.

About Metamark^®
Metamark Genetics, Inc. is a privately held biotechnology company founded to develop novel, function-based prognostic and diagnostic tests aimed at improving cancer care. The company’s proprietary genomic and proteomic discovery platforms have led to significant discoveries in several disease areas, including prostate, bladder, colon and breast cancers. Through the acquisition of Healthtronics Laboratory Solutions in 2013, Metamark has become a leading provider of specialty urological pathology testing services with the first fully integrated clinical model for the prostate cancer care pathway.

For more information please visit the company’s website: www.metamarkgenetics.com.

Metamark^® and ProMark^® are registered trademarks of Metamark Genetics, Inc.

ⁱ Roth, Joshua A., Ramsey, Scott D., Carlson, Josh J. Cost-effectiveness of a biopsy-based 8-protein prostate cancer prognostic assay to optimize treatment decision-making in Gleason 3+3 and 3+4 early-stage prostate cancer. The Oncologist. Published October 2, 2015.

ⁱⁱ Blume-Jensen, Peter., Berman David., Rimm, David L., et al. Development and Clinical Validation of an in situ Biopsy Based Multi-Marker Assay for Risk Stratification in Prostate Cancer. Clin Cancer Res. Published OnlineFirst March 2, 2015.