FDA clears Roche's vitamin D laboratory test
Basel, 26 July 2012
Fully automated assay for widely available platforms offers labs efficient solution to help assess patient vitamin D levels
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.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com or www.roche-diagnostics.us.
All trademarks used or mentioned in this release are protected by law.