RARITAN, NJ--(Marketwire - June 11, 2012) - Ortho-Clinical Diagnostics, Inc. (OCD) today announced CE Marking (Conformité Européenne) for the VITROS® Immunodiagnostic Products Total PSA II Assay and VITROS® Immunodiagnostic Products Free PSA Assay, two new diagnostic tests that aid in monitoring and detecting prostate cancer.
Prostate cancer occurs when a malignant tumor forms in the tissue of the prostate, a gland in the male reproductive system. According to the World Cancer Research Fund International, one in six men is estimated to develop prostate cancer in their lifetime. Early detection is crucial to ensuring better health outcomes for patients.
With the introduction of these fully-automated immunoassays, OCD now offers a fully updated, state-of-the-art oncology portfolio for the early detection of prostate cancer. The VITROS® Total PSA Assay II, a next-generation, prostate-specific antigen test, offers analytical sensitivity with a broad measuring range to help monitor and screen patients. The VITROS® Free PSA Assay, the newest addition to OCD's VITROS® oncology menu, complements the VITROS® Total PSA II Assay to help clinicians better manage their patients. The two assays offer an extremely competitive time-to-first result of 24 minutes, and are approved for use on the VITROS® 5600 Integrated, VITROS® 3600 Immunodiagnostic and VITROS® ECi/ECiQ Immunodiagnostic Systems.
"The competitive performance of these two assays is extremely compelling and we found that the measurement range is better suited to the circumstances we face in our laboratory," said Dr. Jeanne-Pierre Bouilloux, Director of Laboratory at LBM LXBio in South France. "I am pleased that OCD now offers these new tests with low range sensitivities, which are increasingly important for clinicians who have patients treated through hormone therapy or total resection surgery."
The CE Marking secures OCD's prostate cancer assay marketing rights in Europe and other markets that accept CE Marking.
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.