PREVIOUSLY RELEASED BREA, CALIF. (June 23, 2016) Beckman Coulter Diagnostics is pleased to announce the release of a new pancreas specific amylase assay. The Sentinel Pancreatic Amylase reagent and calibrator recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The liquid, ready-to-use reagent, distributed by Beckman Coulter and manufactured by Sentinel Diagnostics, is an important expansion to Beckman Coulter s broad menu offering and is available for use on its AU clinical chemistry analyzers, AU480, AU680 and AU5800. The availability of the pancreatic amylase assay allows Beckman Coulter Diagnostics to provide laboratories with the tools needed to confidently diagnose and monitor acute pancreatitis and acute attacks during chronic pancreatitis, said John Blackwood, senior vice president, chemistry and immunoassay business unit, Beckman Coulter Diagnostics.
Page 2 of 4 Pancreatic amylase is an enzyme produced by the exocrine tissue of the pancreas and aids in the digestion of starches. The Pancreatic Amylase assay is an in vitro diagnostic test used for the quantitative determination of the pancreatic amylase in serum and plasma by enzymatic colorimetric method. The availability of this assay expands Beckman Coulter s comprehensive menu for the AU family of clinical chemistry analyzers. While amylase is a standard test for the diagnosis of pancreatitis, we remember that there are two primary sources of amylase in the human body: the pancreas and salivary glands. The pancreatic amylase test is specific to pancreas as the tissue of origin, and therefore, provides a more targeted test for the diagnosis of pancreatitis, said Jack Zakowski, Ph.D., FACB, director, scientific affairs and professional relations, Beckman Coulter Diagnostics. The new pancreatic amylase assay offers laboratories: Ease of use with barcoded, ready-to-use liquid reagents Good precision and low-end sensitivity (LOD = 0.5 U/L) Reliable and accurate results within a broad assay range of 4.7-2,000 U/L 30-day reagent onboard stability and 14-day calibration frequency
Page 3 of 4 The partnership with Beckman Coulter allows us to reach and assist more laboratories globally to meet their diagnostic needs, said Dr. Ugo De Luca, CEO, Sentinel Diagnostics. We look forward to providing laboratories with specialized options and moving healthcare forward. About Sentinel Diagnostics Sentinel Diagnostics is an Italian company with a long and well established background in the development and production of innovative diagnostic test kits for Clinical Chemistry, Colon Cancer Screening and Molecular Biology to be used on the most complex automated analyzers. Since 1983, Sentinel has privileged the values of quality through technology and innovation and in over thirty years of activity the company has managed to affirm its worldwide market presence. Find out more about Sentinel on www.sentineldiagnostics.com. About Beckman Coulter Beckman Coulter Diagnostics develops clinical diagnostic products that help advance and optimize the clinical laboratory. Beckman Coulter's instruments, systems and tests help streamline processes to enhance efficiency, reduce costs and speed the delivery of results.
Page 4 of 4 For 80 years, Beckman Coulter has been a global leader devoted to providing solutions to laboratories of all sizes, offering a broad portfolio of chemistry, immunoassay, hematology, urinalysis, microbiology, automation and information systems. Beckman Coulter is dedicated to advancing healthcare for every person and moving science, innovation and the lab forward. For more information, visit www.beckmancoulter.com. ###