Metamark Receives Laboratory License in Preparation to Launch ProMark™
News Mar 01, 2014
Metamark Genetics, Inc. has announced that its Cambridge, Mass. 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.
Shawn Marcell, President and Chief Executive Officer of Metamark, commented: "With the licensure of our Cambridge laboratory we have 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.
Marcell continued, "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."
CRISPR Reveals New Targets for Promising Cancer DrugsNews
Novel screening method identifies new drug targets that could potentially enhance the effectiveness of PD-1 checkpoint inhibitors, a promising new class of cancer immunotherapy.READ MORE
Enterome and Nestlé Health Sciences Launch New Diagnostics CompanyNews
Enterome and Nestlé Health Sciences join to create Microbiome Diagnostics Partners, a company that will enable the development and diagnostics for multiple diseases including inflammatory bowel diseases (IBD) and liver diseases.READ MORE
Comments | 0 ADD COMMENT
EMBL Course: Techniques for Mammary Gland Research
Mar 05 - Mar 09, 2018