RARITAN, N.J. (June 4, 2012) — Ortho-Clinical Diagnostics, Inc. (OCD) today announced CE Mark (Conformité Européenne) for the VITROS® Immunodiagnostic Product 25-OH Vitamin D Total Assay, a new diagnostic test to measure levels of vitamin D2 and vitamin D3 in human serum and plasma for use on specific automated VITROS® platforms
More than one billion people globally are estimated to have an insufficiency or deficiency of vitamin D, a pre-hormone that is produced in the skin as a result of sun exposure and plays an essential role in the maintenance of kidneyi, bone and intestinalii health. A vitamin D insufficiency or deficiency can lead to rickets in children, osteomalacia (softening of bones) in adults and, in certain cases, osteoporosis in older adults, among other diseases. A blood test for 25(OH) vitamin D, a metabolite of vitamin D, is the most reliable indicator of vitamin D status, however, current testing methods that require manual operation are labor intensive, time consuming and expensive.
"As we understand more about the overall impact of vitamin D on human health, including its affects on skeletal and other disorders, health care providers are testing more patients for deficiency or insufficiency," said Reinhold Vieth*, Ph.D., Department of Nutritional Sciences, and Department of Laboratory Medicine and Pathobiology, University of Toronto Director. “Reliable and cost-effective testing methods are essential and can ultimately aid in better disease prevention and patient care management."
The VITROS® Immunodiagnostic Product 25-OH Vitamin D Total Assay is a fully-automated, one-step immunoassay approved for use on the VITROS® ECi/ECiQ Immunodiagnostic Systems, the VITROS® 3600 Immunodiagnostic System, and the VITROS® 5600 Integrated System. The availability of this assay adds to the extensive VITROS® portfolio of assays, providing customers with a fast, accurate and easy-to-use test that meets the growing global demand for vitamin D testing.
"The significant global prevalence of vitamin D deficiency and insufficiency as a result of lifestyle changes and reduced sun exposure is driving a growing demand for accurate and efficient vitamin D testing," said Lily Li, M.D., Ph.D.,, manager of scientific affairs, OCD. "With CE Marking of the fully-automated VITROS® Immunodiagnostic Product 25-OH Vitamin D Total Assay, OCD can now offer European customers a vitamin D test that provides equal detection of vitamin D2 and D3 for a more accurate evaluation of the patient's overall vitamin D status."
OCD's 25-OH Vitamin D Total Assay quantitatively measures total 25(OH) vitamin D. The results are used in the assessment of vitamin D sufficiency and may be used in conjunction with other clinical or laboratory data to assist the clinician in patient management. Additionally, the assay has a time to first result of 24 minutes, which allows for improved timeliness of result reporting for higher-volume customers.
The CE Mark allows product commercialization of OCD's vitamin D assay in Europe and other markets that accept CE Mark. OCD recently filed a 510(k) Premarket Notification which is pending clearance by the U.S. Food and Drug Administration (US FDA) for the VITROS® Immunodiagnostic Product 25-OH Vitamin D Total Assay and will be seeking additional regulatory approvals worldwide.
About vitamin D
Vitamin D is a pre-hormone that is mainly produced in skin as a result of sun exposure, or obtained to a lesser extent from the foods we eat, particularly those fortified with the vitamin. It can also be obtained through dietary supplements. Vitamin D is metabolized to 25(OH) vitamin D in the liver and further to 1, 25-(OH)2 vitamin D in the kidneys and other organs. 1, 25-(OH)2 vitamin D is the active form of vitamin D that promotes calcium absorption and helps the body to maintain adequate serum calcium and phosphate concentrations. Vitamin D is important for kidneyi, bone and intestinalii health. In addition, low serum vitamin D levels has also been linked to higher risks of certain non-skeletal diseases, such as cardiovascular diseases, various cancers, autoimmune diseases and infectious diseases. Proper levels of 25(OH) vitamin D help to prevent rickets in children, osteomalacia (softening of bones) in adults and, combined with calcium, helps to protect older adults from osteoporosis.
About VITROS® Systems
VITROS® Systems offer standardized reagents and results, enabling labs to better manage inventories and costs and to be confident in test results from platform to platform – a particular benefit for labs with multiple VITROS® platforms in their facilities. The VITROS® family of systems includes automated, integrated and compact analyzers that offer immunoassay and chemistry detection, to suit the varying needs of different sized laboratories. All VITROS® instruments and systems are designed to incorporate sophisticated information management and interpretation tools to reduce the probability of human error, improve operational efficiencies and increase uptime.
OCD's broad, world-class menu of assays offers all of the most important clinical chemistry tests, covering major disease states including heart disease, cancer, endocrine disease, infectious disease, thyroid disease, metabolic conditions and anemia.
About Ortho Clinical Diagnostics
Ortho-Clinical Diagnostics, Inc. delivers the high-quality in vitro diagnostic products that give healthcare professionals around the world the knowledge they need to make better treatment decisions sooner. The company serves the global transfusion medicine community with donor screening and blood typing products to help ensure every patient receives blood that is safe, the right type and the right unit. Ortho Clinical Diagnostics also brings sophisticated information management, testing technologies, and automation and interpretation tools to clinical laboratories worldwide to help them run more efficiently and improve patient care. For more information, visit www.orthoclinical.com.
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