Ortho Clinical Diagnostics Receives CE Marking for Vitamin D Total Assay

Ortho-Clinical Diagnostics, Inc. (OCD) has received CE Mark (Conformité Européenne) approval 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. The test is designed 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.