Roche has filed a 510(k) submission to the US Food and Drug Administration (FDA) for a fully automated, total vitamin D assay (25-hydroxyvitamin D) for use on Roche’s full portfolio of laboratory analyzers. 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 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 Corp. "This new test will give health care providers confidence in their patient results and, at the same time, enable labs to integrate vitamin D testing into their existing workflow, to save time and maintain ‘lean’ operations."
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 assay is designed for use on all Roche 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. The FDA has a 90-day period after the 510(k) submission for substantive review of the application.
Source: Roche
