Updated on 26 July 2012
Roche vitamin D lab test gets FDA nod
Singapore: Roche received clearance from the US Food and Drug Administration (FDA) for a fully automated vitamin D test for use on cobas modular platforms, further expanding the company's bone metabolism test menu.
The Elecsys Vitamin D assay measures both vitamin D2 and D3, which is important for physicians who have patients taking different forms of vitamin D supplements. Test results are obtained using Roche's patented electrochemiluminescence (ECL) detection technology, which provides a broad measuring range and high precision at the low end of detection to aid in the assessment of severely deficient patients.
Vitamin D is an important building block for human health and is mainly produced in the skin by exposure to sunlight. Vitamin D deficiency plays a major role in bone metabolism disorders, and in recent years studies have linked vitamin D deficiency with many other disease states, including cancer, cardiovascular disease and diabetes. An estimated one billion people suffer from vitamin D deficiency worldwide.
Mr Daniel O' Day, COO, Roche Diagnostics, said that, "The demand for vitamin D testing is increasing rapidly, and having a installed base of cobas analyzers will allow labs to easily respond to that demand and integrate the Roche test into their existing workflow. Adding this test enables them to offer precise and accurate results to help clinicians assess vitamin D sufficiency in adult patients so they can provide optimal care."