San Francisco, CA - Medical practitioners will soon be able to routinely order a new High Sensitivity C-Reactive Protein assay (CRP) now that Olympus Diagnostic Systems Group has designed the test for its standardized AU-Series of chemistry immuno systems. Olympus breakthrough technology allows laboratories to run the assay on their primary clinical chemistry analyzer without the need for a separate nephelometer or heterogeneous immunoassay analyzer. This has broad implications for making the test more readily available in hospital-based, physician group practice, commercial and hospital core laboratories. The Olympus High Sensitivity CRP assay is pending regulatory approval and is not yet available for sale in the U.S.
High sensitivity CRP gives physicians the ability to assess the risk of cardiovascular and peripheral vascular disease in advance of a traumatic event, such as heart attack or stroke. The test detects levels of C-Reactive Protein as low as 0.16 mg/L. This is much lower than conventional CRP assays that have historically been used as a general test for inflammation. CRP levels are being studied by researchers as predictors of risk of heart attack or stroke, particularly since inflammation within the arteries occurs in plaque formation that eventually narrows the arteries, a process known as atherosclerosis.
"The test, now in clinical trials, is highly reproducible," said Dr. Sandy Lepp, Olympus Director of Technology. "The Olympus assay correlates well with the first-generation high-sensitivity CRP tests now on the market and has better sensitivity in detecting even lower levels."
"Our goal is to enhance patient care by bringing the best information to the physician quickly," said Steve Wasserman, Olympus Group Vice President Diagnostic Systems. "Once cleared by the FDA, the assay can be run on any of our AU400TM, AU600TM, AU640TM, AU2700TM*, and AU5400TM* models. These systems have broad application throughout the healthcare delivery market."
Recent studies have indicated that elevation of CRP levels in the "normal range" may be a more specific indicator for risk than cholesterol or lipid abnormalities. Although precise reference values are yet to be established, CRP values as low as 1.5 mg/L may be clinically significant. The Olympus assay has demonstrated minimal interference from lipemia, bilirubin and hemolysis. For additional information about the clinical trials of High Sensitivity C-Reactive Protein, please call the Olympus Diagnostic Systems Group at 1-800-223-0125.
*Pending regulatory clearance. Not available for sale
About Olympus America Inc.
Olympus America Inc. distributes a wide range of products that leverage its core expertise in optics and digital information technology for the consumer, scientific, health care, commercial and industrial markets. These products include film and filmless cameras, microcassette and digital voice recorders, binoculars, film scanners, personal photo printers, medical and industrial endoscopes, biological and metallurgical microscopes and measuring instruments, clinical diagnostic analyzers, and other high technology products. Olympus America Inc. is responsible for sales, marketing, distribution in the United States, Canada, Mexico, the Caribbean, and Central and South America. Located in Melville, N.Y., Olympus America is a subsidiary of Olympus Optical Co., Ltd. with worldwide revenues of $3.8 billion for the year ended March 31, 2000.