METAMARK GENETICS INITIATES CLINICAL USE OF ProMark™
5/6/2014 | Press Release
New Prognostic Biopsy Test Is Designed To Guide
Individual Treatment Decisions About Prostate Cancer
CAMBRIDGE, MA – May 6, 2014 -- Metamark Genetics, Inc. today announced that it has initiated clinical use of the company’s ProMark™ prognostic test to help guide the medical management of patients with early-stage prostate cancer.
ProMark™ is the first and only proteomic multiplex assay for intact biopsy tissue to assess the potential aggressiveness of early-stage prostate tumors prior to therapy. The assay was developed to help physicians and their patients decide whether to treat the cancer aggressively or to choose a course of active surveillance.
Peter Blume-Jensen, M.D., Ph.D., Chief Scientific Officer of Metamark, commented:
“The ProMark™ assay is specifically developed to address the clinical challenges of biopsysampling variation and subjective tumor interpretation that limit the current standard of care. It predicts cancer aggressiveness regardless what part of the tumor the biopsies came from.”
Metamark is working closely with urologists and pathologists to ensure operational efficiency and scalability of commercial processing in its Cambridge, MA laboratory as it moves toward broader launch of the service. The company will also examine operational details such as report generation and review how urologists are integrating ProMark™ analyses into day-today clinical decisions.
Shawn Marcell, President and Chief Executive Officer of Metamark, added: “Men diagnosed with prostate cancer need personalized, precise, and actionable information to aid in the difficult decision of whether to undergo aggressive therapy. ProMark™ addresses this need by enabling objective measurement of protein biomarkers in intact prostate tissue.
“Building on our successful validation study of ProMark™, we have completed additional studies to be published, further expanded our clinical-trial program, and obtained licensure of our CLIA-certified laboratory. We also believe that commercial availability of ProMark™ will enable the generation of additional clinical data as we proceed with a smooth national roll-out this year.”
About prostate cancer
A dilemma confronts many of the 242,000 men in the United States who will be diagnosed this year with prostate cancer. Although prostate cancer is a leading cause of cancer deaths among men, killing about 29,000 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. Aggressive tumors usually necessitate aggressive therapy, most often radical prostatectomy (surgical removal of the entire prostate), sometimes radiation or anti-hormonal treatments. The aggressive course brings serious risks, including long-lasting urinary incontinence and sexual dysfunction. Currently about 87 percent of men choose an aggressive option shortly after diagnosis by needle biopsy (collection of tissue samples for examination), even though the prognosis is often uncertain. More accurate prognosis would enable men with low-risk profiles to more confidently choose a course of active surveillance through periodic monitoring of tumor status, while men with high-risk profiles would have greater assurance that aggressive therapy is the better option. The need for more accurate prognosis is demonstrated by the fact that one in every six men will someday be told that he has prostate cancer.
ProMarkTM is a proprietary test designed to improve the accuracy of prognosis prediction for men diagnosed with prostate cancer. 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 imaging technology that is digitized and fully automated. The resulting analysis is thus completely objective and fully reproducible. A large, multicenter, clinical-development study of ProMarkTM was followed by a blinded, clinical-validation study that met its primary endpoint, demonstrating that the test can aid in differentiating between aggressive and indolent disease. To date, the research program supporting ProMarkTM has completed four clinical studies altogether and additional studies are under way.
Metamark Genetics, Inc. is a privately held biotechnology company founded in 2007 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.metamarkgenetics.com. Metamark™ and ProMark™ are trademarks of Metamark Genetics, Inc.
Vice President, Marketing & Communications