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The test is said to be able to detect low levels of vitamin D even in severely deficient patients.
FDA has cleared healthcare diagnostics firm Roche (Indianapolis) to add a fully automated vitamin D test to its cobas brand of diagnostic equipment to measure levels of vitamin D in patients.
Up to one billion people worldwide suffer from vitamin D deficiency, the brand said. Deficiency is linked to bone metabolism disorders as well as cancer, cardiovascular disease, and diabetes.
“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,” the company said in a press release. Tests results are delivered via the firm’s patented eletrochemiluminescence detection technology, which the company said can detect low levels even in severely deficient patients. The company said the Elecsys test will be available for use on all of its cobas modular analyzer platforms and will expand its bone metabolism testing options.
Daniel O’Day, COO of Roche Diagnostics, said that demand for vitamin D testing is increasing. “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. 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.”