Healthcare Industry News: IPLEX
News Release - May 4, 2009
BD and Fujirebio Diagnostics Sign Worldwide Agreement to Develop Biomarker Assays to Improve Cancer Detection and ManagementAlliance Aims to First Develop Powerful Tools for Detecting Ovarian Cancer Earlier
FRANKLIN LAKES, N.J. and MALVERN, Pa., May 4 (Healthcare Sales & Marketing Network) -- BD (Becton, Dickinson and Company) (NYSE: BDX ) and Fujirebio Diagnostics, Inc., announced today the signing of a worldwide development and supply agreement for oncology diagnostic assays.
Under the agreement, the two companies will develop diagnostic products that incorporate Fujirebio Diagnostics' cancer biomarkers for use on BD's multIPLEX testing platform. The initial products will be directed to the ovarian cancer biomarker, HE4, which is FDA-cleared for monitoring the progression or recurrence of epithelial ovarian cancer. Fujirebio Diagnostics also grants BD, through its BD Diagnostics - TriPath platform, access to its other cancer biomarkers for inclusion in future multIPLEX diagnostic products.
"BD is investing in the development of tools and technologies essential for biomarker-guided cancer care. We believe that biomarker testing in a multIPLEX format can provide clinicians with a powerful toolset for detecting cancer at an earlier stage, which could allow them to begin treatment sooner and improve outcomes," said Wayne Brinster, Vice President and General Manager for Women's Health and Cancer, BD. "By incorporating Fujirebio Diagnostics' cancer biomarkers within our own cancer diagnostics development program, we believe that we are poised to provide clinicians with innovative diagnostic tools for improved patient management and contribute to BD's growth in cancer diagnostics."
"This alliance with BD is an excellent strategic fit for Fujirebio Diagnostics' business," said Paul Touhey, President and Chief Executive Officer, Fujirebio Diagnostics. "It will increase the use of HE4 as a tool in monitoring ovarian cancer and allow Fujirebio Diagnostics to utilize its expertise in cancer biomarker development and manufacturing, providing to physicians additional tools to manage cancer patients."
Studies indicate that early cancer detection can significantly reduce mortality. For example, ovarian cancer is the leading cause of death from gynecologic cancers in the United States and the fifth-leading cause of cancer death in women. An estimated 22,000 new cases occur annually in the United States. The disease is difficult to detect early because it typically triggers few noticeable symptoms. By the time ovarian cancer is detected, it is often too advanced and difficult to control. Research has shown that the five-year survival rate for women diagnosed in the later stages of the disease is as low as 20 to 30 percent. However, the survival rate can be greater than 90 percent when ovarian cancer is detected in its early stages.
Fujirebio Diagnostics developed an HE4 test to be used in conjunction with the company's existing CA125 biomarker, the current gold standard for monitoring ovarian cancer. This combination of biomarkers, as published clinical data shows, provides clinicians with a diagnostic tool that can provide higher sensitivity and specificity than CA125 alone. Improved sensitivity and specificity should allow clinicians to distinguish between benign and malignant pelvic masses more accurately, helping to ensure that patients receive appropriate therapy earlier.
About Fujirebio Diagnostics, Inc.
Fujirebio Diagnostics is the premier cancer diagnostics company and the industry leader in cancer biomarker assays. Fujirebio Diagnostics specializes in the clinical development, manufacturing and commercialization of in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology. Fujirebio Diagnostics is one of the group companies of Miraca Holdings, Inc., in Japan, set up in July 2005 to combine Fujirebio Inc., the leading in-vitro diagnostics company, and SRL, Inc., the top provider of clinical laboratory testing services in Japan. Fujirebio Diagnostics has a worldwide distribution network, which enables physicians and patients to access its diagnostic products. For more information about Fujirebio Diagnostics, please call 610-240-3800 or visit www.fdi.com.
BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 28,000 people in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit www.bd.com.
The following statement pertains to BD. This press release contains certain estimates and other forward-looking statements (as defined under Federal securities laws) regarding BD's performance, including future revenues, earnings per share and income, or events or developments that BD expects to occur or anticipates occurring in the future. All such statements are based upon current expectations of BD and involve a number of business risks and uncertainties. Actual results could vary materially from anticipated results described, implied or projected in any forward-looking statement. With respect to forward-looking statements contained herein, factors that could cause actual results to vary materially from any forward-looking statement include, but are not limited to: adverse changes in regional, national or foreign economic conditions, including any impact that may result from the current downturn in the world financial markets and major economies on our ability to access credit markets and finance our operations or the demand for our products and services; changes in interest or foreign currency exchange rates, particularly in light of increased volatility in currency exchange rates; competitive factors; pricing and market share pressures; difficulties inherent in product development and delays in product introductions; increases in energy costs and their effect on, among other things, the cost of producing BD's products; fluctuations in costs and availability of raw materials and in BD's ability to maintain favorable supplier arrangements and relationships; uncertainties of litigation (as described in BD's filings with the Securities and Exchange Commission); the effects of potential pandemic diseases; changes in healthcare or other governmental regulation, including changes in government pricing and reimbursement policies or other cost containment reforms; and issuance of new or revised accounting standards, as well as other factors discussed in this press release and in BD's filings with the Securities and Exchange Commission. We do not intend to update any forward-looking statements to reflect events or circumstances after the date hereof except as required by applicable laws or regulations.
Source: Becton Dickinson
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