Download FOR IMMEDIATE RELEASE MEDIA CONTACT: June XX, 2012

FOR IMMEDIATE RELEASE
June XX, 2012
MEDIA CONTACT:
Kaitlin Meiser
(908) 704-3888
Cell
(908) 938-3209
ORTHO CLINICAL DIAGNOSTICS RECEIVES FDA CLEARANCE FOR A NEW TEST TO
DETECT TOTAL VITAMIN D LEVELS
Provides U.S. laboratories with fast, accurate, easy-to-use assay that meets growing demand for
vitamin D testing
RARITAN, N.J. (June XX, 2012) — Ortho-Clinical Diagnostics, Inc. (OCD) today announced U.S.
Food and Drug Administration (FDA) clearance for the VITROS® Immunodiagnostic Products 25-OH
Vitamin D Total Assay, a new diagnostic test to measure total vitamin D levels in human serum and
plasma for use on specific automated VITROS® systems.
More than three quarters of all adults in the United States are either insufficient or deficient in vitamin
Di, a pre-hormone that is produced in the skin from sun exposure or obtained through dietary intake.
Vitamin D plays an essential role in the maintenance of bone health. A vitamin D insufficiency or
deficiency can lead to rickets in children, osteomalacia (softening of bones) in adults and, in certain
cases, osteoporosis. Low serum vitamin D levels also have been linked to higher risk for a variety of
other diseases and health issues including: cardiovascular disease, autoimmune diseases, infection
disease, various cancers and is associated with longer hospital stays and poor surgical outcomes.
“With the growth of knowledge about the effects of vitamin D on human health, including skeletal and
other disorders, the demand for vitamin D testing has grown dramatically.” said Reinhold Vieth*, Ph.D.,
Department of Nutritional Sciences, and Department of Laboratory Medicine and Pathobiology,
University of Toronto. “Reliable and cost-effective methods for 25-hydroxyvitamin D are essential and
can ultimately aid in better disease prevention and patient care management.”
Through a simple blood test, the VITROS® Immunodiagnostic Product 25-OH Vitamin D Total Assay
measures for 25(OH) vitamin D, a metabolite of vitamin D. The assay exhibits equal detection of
vitamin D2 and vitamin D3, the two major forms of vitamin D in the body, and provides the most complete
measure of an individual’s vitamin D status, which may be used in conjunction with other clinical or
laboratory data to assist the clinician in patient disease management. Additionally, the assay has a fast
time to first result of 24 minutes, which allows for improved timeliness of result reporting for highervolume customers.
“A blood test for 25(OH) vitamin D is the most reliable indicator of vitamin D status, however, some
current testing methods that require manual operation are labor intensive and time consuming,” said
Colin Hill, worldwide clinical laboratories marketing director, OCD. “With FDA clearance of the fullyautomated VITROS® 25-OH Vitamin D Total Assay, OCD now offers a highly accurate, complete
vitamin D test that provides healthcare providers with confidence in patient results while providing
laboratories with a time-saving test that can be easily integrated into their current workflow on a single,
broad menu system.”
The VITROS® Immunodiagnostic Products 25-OH Vitamin D Total Assay is 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.
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 bone 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® series 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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i
National Health and Nutrition Examination Survey (NHANES) III from 2001 to 2004
*Dr. Vieth is compensated for certain consulting services he provides to Ortho-Clinical Diagnostics, Inc.