Metamark Genetics has announced that its Cambridge, Massachusetts laboratory has been licensed for the highest level of clinical testing in the use of ProMark, the company's prognostic assay to guide the medical management of patients with prostate cancer.
The licensure by the State of Massachusetts for ‘high-complexity testing’ establishes the CLIA-certified laboratory as the national site for processing prostate-tissue samples upon the commercial introduction of ProMark planned for early 2014.
The licensure follows the completion last year of a clinical-validation study of ProMark that met its primary endpoint in differentiating between aggressive and indolent disease. Altogether, Metamark has completed four clinical studies of ProMark comprising 1,275 patients.
Metamark president and CEO Shawn Marcell noted with the licensure of its Cambridge laboratory the company has taken another step toward launching ProMark so physicians and their patients can use this novel prognostic to address one of the most agonizing questions in men’s healthcare — whether a newly diagnosed prostate cancer will spread or whether it will harmlessly remain within the prostate.
"As we prepare to commercialize ProMark™, we are also designing additional clinical studies to further delineate the potential of this new tool to guide the decision whether to treat prostate cancer aggressively or to choose the conservative option of active surveillance.
"We believe the unique format of ProMark™, which enables objective measurement of protein biomarkers in intact prostate tissue, can improve the management of prostate cancer much as other molecular tools have improved the treatment of breast and ovarian cancer," Marcell added.