Roche Announces FDA Clearance for Vitamin D Assay

Roche 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. An estimated one billion people suffer from vitamin D deficiency worldwide.

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.

“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.”

The test will be available for use on all of Roche’s cobas modular analyzer platforms. Roche also has a vitamin D test available in Europe and other regions accepting the CE mark.