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."
Targeted Drug Could be Used to Treat Advanced Cancers Located Anywhere in the BodyNews
A new targeted drug could be used to treat a small number of advanced cancers no matter where they grow in the body.READ MORE
Investigational Drug for Melanoma Shows Promise in Early-Stage StudyNews
An investigational compound designed to block a hyperactive cell growth signal in advanced melanoma and other cancers has shown some promise in an early-stage clinical trial researchers have reported.READ MORE
‘Mini Tumors’ from Patient Samples Could Help Personalize Cancer Drug TreatmentNews
Testing cancer drugs on miniature replicas of a patient’s tumour could help doctors tell in advance which treatments will work, a major new study reports.READ MORE