FDA clears Roche's vitamin D laboratory test
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Roche announced that it has received clearance from the U.S. 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.
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.
“The demand for vitamin D testing in the U.S. is increasing rapidly, and having a large installed base of cobas analyzers will allow labs to easily respond to that demand and integrate the Roche test into their existing workflow,” said Daniel O’ Day, Chief Operating Officer of Roche Diagnostics. “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.”
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