|
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.
Olympus America Press contact:
Vincent Park
914-684-0959
vincent@edge-comm.net
|