Roche (Indianapolis, IN, USA) has filed a 510(k) submission to the US Food and Drug Administration (FDA; Silver Spring, MD, USA;) for a fully automated, total vitamin D assay (25-hydroxyvitamin D) for use on Roche's full portfolio of laboratory analyzers. The FDA has a 90-day period after the 510(k) submission for substantive review of the application.

The Elecsys vitamin D test can be combined with routine testing on existing Roche immunoassay analyzers and integrated chemistry/immunoassay systems, enabling labs to address the growing demand for vitamin D testing while maximizing their productivity. The assay is designed for use on immunoassay systems for low-, mid- and high-volume testing environments, including the Elecsys 2010, cobas e 411, cobas e 601, cobas e 602, and Modular Analytics E170 analyzers.

According to the National Institutes of Health Office of Dietary Supplements, the serum concentration of 25(OH) D is the best indicator of vitamin D status. It reflects vitamin D produced cutaneously (D3) and obtained from food and supplements (D2 and D3). The ability of an assay to detect both D2 and D3 forms (total vitamin D) is important for physicians who have patients taking vitamin supplements.

"The demand for vitamin D testing is increasing rapidly, as global deficiency rates rise and studies show a link between insufficiency and disease states," said Randy Pritchard, vice president of marketing at Roche Diagnostics Corporation.

Roche is a world leader in in-vitro diagnostics, tissue-based cancer diagnostics, and a pioneer in diabetes management. Headquartered in Basel, Switzerland, Roche is a biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism, and CNS.

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