Application Submitted for the First Blood Test for Mesothelioma
May 3, 2005 - 10:01:00 AM
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"We are pleased to bring this new and exciting diagnostic tool for monitoring mesothelioma before the FDA for review. MESOMARK further demonstrates FDI's commitment to deliver novel, innovative and noninvasive technologies that help patients and physicians better manage cancer."
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By Fujirebio Diagnostics, Inc.,
[RxPG] Fujirebio Diagnostics, Inc. (FDI), a world-leader in oncology testing, today announced that it submitted a 510K application to the U.S. Food and Drug Administration (FDA) on April 29, 2005 for clearance of MESOMARK(TM), the first blood test for mesothelioma.
"We are pleased to bring this new and exciting diagnostic tool for monitoring mesothelioma before the FDA for review," said Paul Touhey, president and COO for FDI. "MESOMARK further demonstrates FDI's commitment to deliver novel, innovative and noninvasive technologies that help patients and physicians better manage cancer."
MESOMARK, a manual enzyme-linked immunosorbent assay (ELISA), works by identifying serum tumor markers called soluble mesothelin-related peptides (SMRP). These proteins are released into the bloodstream by malignant mesothelioma cells. FDI's mesothelioma assay is a two-step immunoassay that quantitates SMRP in human blood using a standard ELISA microplate sandwich assay format.
About Mesothelioma
Malignant Pleural Mesothelioma is a highly aggressive form of cancer found in the lining of the chest, the abdominal cavity and around the heart, in which fluid accumulates between the lining of the lungs and chest cavity. It is primarily caused by work-related asbestos exposure and has an average latency period of 30-40 years. Over 100 million people worldwide have been occupationally exposed to asbestos in the past five decades. Rates of mesothelioma have tripled in the last 20 years and it is estimated that 10,000 new cases are diagnosed each year among industrialized countries.
Recent epidemiological studies predict an increase in this number in the next few decades. Up until now, there have been no reliable serum tumor markers for mesothelioma, which means that diagnosis, screening and monitoring responses to treatment have been difficult. In addition, mesothelioma is notoriously resistant to chemotherapy and radiotherapy, and is rarely cured by radical surgery.
Publication:
U.S. Food and Drug Administration (FDA)
On the web:
www.fdi.com 
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Additional information about the news article
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About FDI
Fujirebio Diagnostics, Inc. (FDI) is a premier diagnostics company and the industry leader in tumor marker assays. FDI 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. In November 1998, Fujirebio, Inc. of Tokyo, Japan, acquired the company, formerly known as Centocor Diagnostics. FDI utilizes its worldwide distribution network to enable access by physicians and patients to its diagnostic products. For more information about FDI, please call 610-240-3800 or visit www.fdi.com.
Forward-Looking Statement
Any statements in this press release about future expectations, plans or prospects for the Company, including the Company's expectations and its plans to complete the FDA approval process for MESOMARK constitute forward-looking statements. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. FDI undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect FDI's business.
Contacts
Fujirebio Diagnostics, Inc.
by
Dudnyk Public Relations
Gary J. Gatyas, Jr.
267-532-1244 (office)
215-378-5729 (mobile)
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