Oct 19, 2011 - FDA Clears Siemens Fully Automated Vitamin D Total Assay

FDA Clears Siemens Fully Automated Vitamin D Total Assay for ADVIA Centaur Systems

U.S. laboratories can now meet increasing demand for vitamin D testing and assay consolidation on a high efficiency analyzer with access to precise, accurate results in as little as 18 minutes

TARRYTOWN, N.Y., Oct. 19, 2011 /PRNewswire/ -- The FDA has cleared the Siemens Healthcare Diagnostics (NYSE: SI) Vitamin D Total assay for use on the ADVIA Centaur®/XP Immunoassay Systems, enabling laboratories to consolidate vitamin D testing with routine testing on a single, fully automated immunoassay platform. The assay, which is traceable to LC/MS/MS (liquid chromatography-mass spectrometry), measures the total level of 25-hydroxyvitamin D [25(OH)D] in serum and plasma to aid in the assessment of vitamin D sufficiency. Measurement of [25(OH)D], the most widely used indicator of vitamin D status, ensures accurate evaluation of patients for deficiency, sufficiency, or toxicity.

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As people limit their sun exposure due to the risk of skin cancer, vitamin D deficiency rates have been increasing globally. In the U.S., approximately 77 percent of adults are either insufficient or deficient in vitamin D, according to the National Health and Nutrition Examination Survey (NHANES) III from 2001 to 2004. While vitamin D deficiency has long been associated with rickets, osteomalacia (softening of the bones), and osteoporosis, recent studies have also linked it to disease states, including cancer, cardiovascular, diabetes, and autoimmune diseases.(1)

Rising deficiency rates and increasing evidence of vitamin D sufficiency as a general health indicator have driven demand for more vitamin D testing. However, not all vitamin D tests are the same. A number of studies have reported discrepancies between assays used to measure vitamin D, calling into question the ability of some assays to accurately identify individuals affected by vitamin D deficiency.(2)

To ensure accuracy, the Siemens' ADVIA Centaur Vitamin D Total assay measures a patient's total 25(OH) vitamin D level – ~100% of 25 (OH) vitamin D2 and D3, metabolites of the two major forms of vitamin D. Because circulating 25(OH)D can arise from hydroxylation of either vitamin D2 or D3, measurement of total 25(OH)D (both D2 and D3) is essential for accurate assessment of vitamin D status.(2)

"In order to meet the demand for vitamin D testing, laboratories are under increasing pressure to enhance efficiency while providing reliable results," said David Hickey, CEO, Chemistry, Immunoassay, Automation & Diagnostics IT Business Unit, Siemens Healthcare Diagnostics. "With the ADVIA Centaur Vitamin D Total assay, laboratories can now consolidate vitamin D testing into their existing workflow, saving time and money, while meeting clinicians' expectations for fast and accurate results.

For more information about the ADVIA Centaur Vitamin D Total assay, visit: www.siemens.com/vitamindtotal.

(1) Dietary Supplemental Fact Sheet: Vitamin D Office of Dietary Supplements. National Institutes of Health, updated 11/13/2009 (2) http://www.nist.gov/mml/analytical/organic/vitamindinserum.cfm

The Siemens Healthcare Sector is one of the world's largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens offers its customers products and solutions for the entire range of patient care from a single source – from prevention and early detection to diagnosis, and on to treatment and aftercare. By optimizing clinical workflows for the most common diseases, Siemens also makes healthcare faster, better and more cost-effective. Siemens Healthcare employs some 48,000 employees worldwide and operates around the world. In fiscal year 2010 (to September 30), the Sector posted revenue of 12.4 billion euros and profit of around 750 million euros. For further information please visit: www.siemens.com/healthcare

SOURCE Siemens Healthcare