Olympus Announces FDA Clearance and U.S. Release of CEA Tumor Marker Assay For AU3000i® Immunoassay System
CENTER VALLEY, Pa., April 14, 2009 – Olympus, a leader in the field of in vitro diagnostics, has received FDA clearance for a Carcinoembryonic Antigen (CEA) test for the Olympus AU3000i immunoassay system. CEA is assigned to a group of markers indicating the presence of carcinomas such as those present in the colon.
The Olympus CEA assay is a two-step paramagnetic particle enzyme immunoassay with a measuring range of approximately 0.08 - 500 ng/mL. It measures quantitative concentrations of CEA in 50 microliters of either serum or lithium-heparin plasma samples after 28 minutes of processing time. Samples containing CEA concentrations exceeding 500 ng/mL are auto-diluted onboard (1:1000) for a clinical reportable range of approximately 500,000 ng/mL. Each CEA kit is sufficient to process 200 tests, and contains CEA reagents, a single ready-to-use calibrator, and a single ready-to-use control. Reagents are stable onboard the AU3000i system for 28 days.
For additional information about the Olympus AU3000i immunoassay system and related assays, contact Susan M. Watanabe at 1-484-896-5686, or via email at Susan.Watanabe@olympus.com; visit www.olympusamerica.com/AU3000i.
About this test
The Olympus CEA assay is a paramagnetic particle chemiluminescent immunoassay for the in vitro quantitative measurement of CEA in human serum or lithium-heparin plasma. It is traceable to the 1st IRP WHO Reference Standard 73/601 for human CEA.
About Olympus Diagnostic Systems
Olympus Diagnostic Systems provides innovative solutions that meet the high productivity demands of hospitals, integrated healthcare delivery networks, reference labs, blood banks, physician offices and pharmaceutical labs. Olympus offers the broadest standardized line of random access chemistry-immuno analyzers, along with lab automation systems, blood bank analyzers and reagents. Olympus solutions save laboratories time, maximize productivity, and deliver fast, reliable results.
Olympus is a precision technology leader, creating innovative opto-digital solutions in healthcare, life science and consumer electronics products. Olympus works collaboratively with its customers and its affiliates worldwide to leverage R&D investment in precision technology and manufacturing processes across diverse business lines. These include:
· Gastrointestinal endoscopes, accessories, and minimally invasive surgical products;
· Advanced clinical and research microscopes;
· Lab automation systems, chemistry-immuno and blood bank analyzers and reagents;
· Digital cameras and voice recorders.
Olympus serves healthcare and commercial laboratory markets with integrated product solutions and financial, educational and consulting services that help customers to efficiently, reliably and more easily achieve exceptional results. Olympus develops breakthrough technologies with revolutionary product design and functionality for the consumer and professional photography markets, and also is the leader in gastrointestinal endoscopy and clinical and educational microscopes. For more information, visit www.olympusamerica.com.