Ortho-Clinical Diagnostics, Inc. (OCD) announced CE Mark (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.