Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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.”
An estimated one billion people suffer from vitamin D deficiency worldwide.
About the Test
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 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.
