The Elecsys® N-MID Osteocalcin immunoassay from Roche Diagnostics has received clearance from the US Food and Drug Administration. The test is used to make an in vitro quantitative determination of the amount of N-MID Osteocalcin in human serum and plasma. Osteocalcin, a protein found in bones and in blood serum, is an indication of bone formation. The test can be used on the Elecsys 1010 and Elecsys 2010 systems, and in the MODULAR ANALYTICS E 170 module.
“The Osteocalcin immunoassay expands our market-leading portfolio of bone-marker tests, which also includes the Elecsys Beta-CrossLaps and Elecsys PTH assays. By closely managing osteoporosis using the Elecsys N-MID Osteocalcin test, physicians will be able to help improve patient outcomes by being able to rapidly demonstrate the efficacy of a treatment,” says Andrew Thomson, senior vice president, Roche Centralized Diagnostics.
“Osteocalcin has established utility in the management of bone disease due to its excellent intra-individual variation and specificity. It is elevated in those patients with high bone turnover rates and nicely complements Beta CrossLaps tests for monitoring the effectiveness of antiresoptive therapy in patients with osteoporosis or low bone mass,” says Michael Kleerekoper, MD, FACB, FACE, professor of medicine at Wayne State University in Detroit. “The International Osteoporosis Foundation recommends bone markers, including serum Osteocalcin, for therapy monitoring of antiresoptive agents.”
Roche Diagnostics
(800) 981-8863; www.rochediagnostics.com
