Metamark Announces Nationwide Availability of ProMark™ Prostate Cancer Test, First-of-its-Kind Protein-Based Prognostic Test

10/9/2014 | Press Release

ProMark™ Validated to Predict Disease Aggressiveness and Empower Informed Treatment Decisions

CAMBRIDGE, Massachusetts, October 9, 2014 – Metamark announced today the nationwide availability of ProMark™, the first-of-its-kind protein-based biopsy test designed to improve the accuracy of prognosis for men diagnosed with prostate cancer. For the 205,000 men annually with indeterminate Gleason scores (3+3 and 3+4), ProMark can help identify aggressiveness of the disease.

“Enhancing risk stratification is especially important with newly diagnosed prostate cancer patients, which can assist with their understanding of treatment options. Adding a proteomic test, in addition to traditional metrics of physical examination, PSA, and histopathology, could improve shared decision making," said Neal D. Shore, MD, medical director of the Carolina Urologic Research Center. “The ProMark test may provide the healthcare community with additional information to assist distinguishing indolent from aggressive prostate cancer, thus
better informing decisions on an appropriate course of treatment or surveillance.”

ProMark has been validated in multiple clinical studies totaling more than 1,250 cases, all of which demonstrated the ability to differentiate between aggressive and non-aggressive forms of prostate cancer at early stages of disease. Results of a blinded clinical validation study were presented at the 2014 American Society of Clinical Oncology annual meeting, which showed ProMark predicted which patients had low-risk disease with a high sensitivity, thereby helping to identify patients who may be appropriate candidates for active surveillance or in need of aggressive therapy.

ProMark works by measuring the amount of specific protein biomarkers obtained by needle biopsy from regions of prostate tissue where the biomarkers are altered during tumor formation.   The molecular data that determine prognosis can be measured at a very early stage of the disease with ProMark, before key treatment choices must be made.

“Metamark has served the urology space exclusively for years, and as such, we understand the unique challenges and uncertainties faced by patients and physicians,” said Metamark CEO Shawn Marcell. "ProMark is a valuable tool that will address the urology community’s unmet need for having actionable information, by providing an individualized risk assessment to men whose biopsies have indicated disease presence.”

Metamark is committed to ensuring that men with early stage prostate cancer have the information they need prior to key decisions about their care and has made patient access to ProMark a priority upon launch. The company will be working diligently with insurance companies and payer groups to introduce reimbursement.
For more information about requesting ProMark with your healthcare team, visit Metamark’s website at www.metamark.us.


About Prostate Cancer1
A dilemma confronts many of the 233,000 men in the United States who will be diagnosed this year with prostate cancer based on biopsy sampling. Although prostate cancer is a leading cause of cancer deaths among men, killing roughly 29,480 annually, the majority of prostate tumors are indolent and associated with little risk to health or longevity. The dilemma arises from the difficulty in distinguishing between aggressive and indolent tumors as crucial medical decisions are being made, especially for the approximately 205,000 men annually with biopsy Gleason scores of 3+3 and 3+4 who must evaluate their treatment options.2 Currently about 87 percent of these men with early stage prostate cancer elect aggressive therapy, although only
3-7 percent progress over lifetime. Aggressive therapy, most often in the form of radical prostatectomy or radiation, has significant side effects, such as incontinence and impotence, so addressing this significant overtreatment is critical.

About ProMark™
ProMark™ is designed to improve the accuracy of prognosis for men diagnosed with prostate cancer, specifically the approximately 85% of prostate cancer patients with biopsy Gleason grades 3+3 or 3+4 for whom standard-of-care based medical decision making is currently insufficient. The test measures the amount of specific protein biomarkers obtained by needle biopsy from regions of prostate tissue where the biomarkers are altered during tumor formation. These “regions of interest” are rendered as intact, paraffin-embedded tissue sections.

Quantitative measurements of the biomarkers are then determined by means of fully automated digital imaging technology. The resulting analysis is completely objective and fully reproducible. A large, blinded, clinical-validation study of ProMark met its primary endpoint, demonstrating that the test can aid in differentiating between aggressive and indolent disease. The research program supporting ProMark has completed four clinical studies altogether comprising over 1,250 patients, with additional prospective studies underway. Metamark is commercializing ProMark through the company's CLIA-certified laboratory in Cambridge, Massachusetts. For more information, visit: www.metamark.us.

About Metamark
Metamark 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 yielded significant discoveries in several disease areas, including prostate, bladder, colon, and breast cancers. Through the acquisition of Healthtronics Laboratory Solutions last year, Metamark has become a leading provider of specialty urological pathology testing services throughout the United States. For more
information, please visit the company's website at www.metamark.us. Metamark™ and ProMark™ are trademarks of Metamark.

1 National Cancer Institute. Surveillance, Epidemiology, and End Results (SEER) Program. SEER Stat Fact Sheets: Prostate Cancer. http://seer.cancer.gov/statfacts/html/prost.html. Accessed September 2014.
2 Epstein JI, Feng Z, Trock BJ, Pierorazio PM. Upgrading and downgrading of prostate cancer from biopsy to radical prostatectomy: incidence and predictive factors using the modified Gleason grading system and factoring in tertiary grades. European Urology 61(5): 1019-24. 
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