NEW YORK (GenomeWeb News) – Metamark Genetics today announced that Massachusetts has licensed the company's laboratory as it prepares to launch its prognostic assay for managing patients with prostate cancer.
The lab in Cambridge, Mass. is CLIA-certified, but a handful of states require additional regulatory approval before certain tests can be performed.
Metamark said that it anticipates launching its prostate cancer test called ProMark early this year. The test measures the amount of specific protein biomarkers from needle biopsies and is designed to improve the accuracy of prognosis for men who have been diagnosed with prostate cancer.
Massachusetts' licensure of the company's lab follows the completion of a clinical validation study last year of ProMark that met its primary endpoint in differentiating between aggressive and indolent disease. Metamark has completed four clinical studies of ProMark involving 1,275 patients, the firm said.
"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," Metamark President and CEO Shawn Marcell said in a statement.