Metamark Announces Publication of Clinical Validation Study for the ProMark™ Prostate Cancer Prognostic Test

3/9/2015 | Press Release

March 09, 2015 09:55 AM Eastern Daylight Time

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Metamark announced today that results of its clinical validation study for the ProMark™ prostate cancer test were published online in Clinical Cancer Research. In the paper, titled "Development and Clinical Validation of an in situ Biopsy Based Multi-Marker Assay for Risk Stratification in Prostate Cancer" researchers validated use of the 8-biomarker assay in over 650 cases to provide prognostic information that may improve clinical decision-making following prostate biopsy.

“Every year thousands of men face unnecessary interventions following prostate cancer biopsy. ProMark™ was developed as a direct result of our dedicated efforts to ensure that all men and their doctors have access to the best information possible in order to help them survive and thrive following this difficult diagnosis.”

Prof. Fred Saad, M.D., FRCS, Centre Hospitalier de l'Université de Montréal and a lead author of the study stated, "Current clinical and pathologic parameters in biopsy sampling do not adequately provide the type of risk prediction needed to avoid overtreatment and provide the requisite opportunity for curative therapy. By providing independent prognostic information about the disease state at the time of biopsy, the ProMark test can serve as an important tool for stratifying patients for active surveillance versus therapeutic intervention."

Prostate cancer is the second most common type of cancer in the United States and the second leading cause of cancer death among men– with nearly 30,000 men dying from the disease each year.i Patients who receive a positive diagnosis for prostate cancer face a wide variety of treatment options based on their individual situations, including radiation, surgery, hormone therapy or surveillance.ii Due to the serious effects treatment can have on patients’ quality-of-life, recent studies have recommended more conservative treatment plans for patients with a low risk of malignancy.iii

The ProMark™ assay is a first-of-its-kind proteomic-based biopsy test that helps physicians and their patients with prostate cancer to determine the most appropriate treatment options by aiding in the differentiation between aggressive and indolent disease. Using tissue from a man’s biopsy, the ProMark test provides a personalized prediction that the cancer can be managed without aggressive treatment. ProMark is the only standalone prognostic test for prostate cancer validated to date.

“We’re incredibly pleased that the results of this important research have been published,” said Metamark CEO Shawn Marcell. “Every year thousands of men face unnecessary interventions following prostate cancer biopsy. ProMark™ was developed as a direct result of our dedicated efforts to ensure that all men and their doctors have access to the best information possible in order to help them survive and thrive following this difficult diagnosis.”

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 medical decision making is currently insufficient. ProMark uses an automated, quantitative multiplex immunofluorescence method to measure the protein levels of 8 biomarkers directly on sections of prostate biopsy tissue. The biomarkers individually and together predict the probability a cancer has not extended beyond the prostate, or has histological features of aggressive tumors. ProMark test results provide a man’s probability of non-aggressive disease independent from clinico-pathological findings. Results can also be combined with additional clinico-pathologic data to provide even greater confidence to guide appropriate clinical decision-making. 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, and additional prospective studies are underway. Metamark has offered ProMark testing through the company's CLIA-certified, CAP accredited laboratory in Cambridge, Massachusetts since October 2014. For more information, visit: www.metamarkgenetics.com.

About Metamark
Metamark is a privately held company dedicated to improving cancer care by providing the next generation of diagnostic and prognostic testing. The company is advancing its contribution to oncology through its proprietary genomics and proteomics discovery platforms, a growing clinical research effort, and corporate alliances. Metamark has assembled a unique portfolio of testing services and products to inform critical decisions at each step of the care pathway in prostate cancer. The company’s interests also include bladder, colon, and breast cancers. For more information, please visit the Metamark website at www.metamarkgenetics.com. Metamark™ and ProMark™ are trademarks of Metamark.

i CDC. United States Cancer Statistics: 1999–2011 Cancer Incidence and Mortality Data. Retrieved from: http://apps.nccd.cdc.gov/uscs/.
ii American Cancer Society. Prostate Cancer Fact Sheet. Retrieved from: http://www.cancer.org/acs/groups/cid/documents/webcontent/003134-pdf.pdf
iii Klotz, L. Prostate cancer overdiagnosis and overtreatment. Current Opinion in Endocrinology, Diabetes and Obesity. 2013 Jun;20(3):204-9.

Contacts
Metamark Genetics
Filip Rosseel, 858-210-8297
Filiprosseel@mac.com