Olympus will optimize Bayer’s assay for the Olympus AU3000i immunoassay analyser
Distribution agreement to expand access to Bayer HealthCare automated BNP assay
Leverkusen, July 22, 2005 - Bayer HealthCare, Diagnostics Division, a member of the Bayer Group (NYSE:BAY) and Olympus Life and Material Science Europa GmbH announced today that the companies signed a non-exclusive supply and distribution agreement in the diagnostics testing arena. The agreement will expand access for physicians and healthcare providers to an automated assay for B-type Natriuretic Peptide (BNP) testing. Recent research has shown that elevated levels of BNP indicate the presence of heart failure, thus providing physicians with an important diagnostic tool in the early detection and management of heart failure (HF).
Based on the terms of the agreement, Olympus will optimize Bayer Diagnostics’ BNP assay for use on the company’s new Olympus AU3000i, which is currently scheduled for release in 2005 in Europe and 2006 in the United States, pending clearance from the Food and Drug Administration (FDA). Bayer HealthCare Diagnostics plans to file for clearance from the FDA and manufacture product for Olympus’ direct distribution to its diagnostics customers worldwide except Japan.
“The ability to offer BNP on our AU3000i Immunochemistry System is of enormous importance”, stated Dr. Helmut Köhler, Managing Director of Olympus Life and Material Science.
“BNP is one of the fastest growing blood tests in the U.S. Working with Bayer Diagnostics is the right decision in gaining access to this crucial market on behalf of our customers and their patients,” added Stephen Wasserman, Group Vice President, Diagnostics Systems, Olympus America Inc.
“Bayer Diagnostics is in a fortunate position to enable other diagnostics manufacturers access to the BNP assay,” stated Tom Warekois, Senior Vice President of Global Strategic Marketing for Bayer Diagnostics. “The BNP assay is just one example of Bayer’s ongoing commitment to improving life through scientific innovation. Providing the BNP assay to additional diagnostics vendors will help drive the benefits of BNP testing to patients and healthcare providers globally.”
B-type Natriuretic Peptide or BNP is a rapidly expanding area for cardiovascular testing. The BNP molecule is physiologically active serving as a direct biological response to cardiovascular stress. This attribute allows BNP testing to provide a representation of a patient’s cardiac situation at the time a blood sample is drawn, which in turn, allows for more timely treatment and patient management.
Bayer HealthCare Diagnostics’ BNP Assay
Bayer HealthCare Diagnostics, in 2003, received FDA clearance for its fully-automated BNP test as an aid in the diagnosis of heart failure. The following year, Bayer Diagnostics received FDA clearance for two added claims – the prediction of survival in patients after myocardial infarction and assessment of heart failure severity in patients diagnosed with congestive heart failure. In May 2005, two additional claims received 510(k) clearance; in patients with acute coronary syndromes (ACS), the BNP assay, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure.
Bayer Diagnostics licensed BNP directly from Shionogi Corporation in Japan. Bayer’s in vitro diagnostic test for the quantitative determination of BNP is available for worldwide use on the Bayer ADVIA Centaur®, the ACS:180® Immunoassay Systems and pending FDA clearance, will be available on the Olympus AU3000i system.
About Olympus Life and Material Science Europa GmbH
Olympus Life and Material Science Europa GmbH unites the fields of Microscopy and Diagnostics covering a broad spectrum of customer needs ranging from microscope systems for life and material science, to high-performance diagnostics instruments and reagents for IVD laboratories. The company belongs to the Olympus Europe Group and represents the worldwide 'centre of excellence' for Olympus IVD reagents, lab automation and bioanalytical software of the Olympus Diagnostic division. This division of Olympus provides innovative and intelligent solutions that meet the high productivity demands of hospitals, integrated healthcare delivery networks, reference labs, blood banks and pharmaceutical labs. Olympus offers a broad standardized line of random access chemistry-immuno systems including reagents, along with lab automation systems, comprehensive patient safety systems, blood bank analyzers and reagents.
About Bayer HealthCare AG
Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the health care and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro.
The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Bayer HealthCare employed 35,300 people worldwide in 2004.
Bayer HealthCare’s aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.
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