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Fujirebio Diagnostics Honored with Pioneer Award from MARF
Company Recognized for Substantial Contributions to Mesothelioma Research And the MESOMARK(TM) Test, the First Blood Test for Mesothelioma
11/7/2005 - Fujirebio Diagnostics, Inc. (FDI), a world-leader in in-vitro diagnostics, was recently honored with a Pioneer Award from the Mesothelioma Applied Research Foundation (MARF). FDI, one of several companies presented with a Pioneer Award at MARF's Second International Symposium on Malignant Mesothelioma, received the award for substantial contributions to mesothelioma research and the MESOMARK(TM) test, the first blood test for mesothelioma.
"Fujirebio Diagnostics is committed to providing highly-effective diagnostic tools to better manage this aggressive form of cancer," said Monte Wiltse, vice president of sales and marketing for FDI. "We at Fujirebio Diagnostics thank MARF for the Pioneer Award and look forward to a continued, productive partnership as we make strides together in overcoming this challenging disease."
The Pioneer Award features a reproduction of a painting of a compass on a chart by a mesothelioma patient. Chris Hahn, executive director of MARF, explained that the painting symbolically links the pioneer-like journey of mesothelioma patients and researchers today to early American pioneers who explored uninhabited territory for the benefit of others.
"With Mesothelioma historically having trouble attracting research dollars from companies, the Pioneer Award is meant to thank and honor companies that have significantly invested in improving outcomes for mesothelioma patients," Hahn said. "Fujirebio Diagnostics is one of the leading biomarker companies in the world. Its investment in this new field of diagnostics improves treatment and life for mesothelioma patients. We're extremely grateful to Fujirebio Diagnostics for its investment in mesothelioma research. We know the award and discussions at the symposium were encouraging to mesothelioma patients and their families in attendance."
The MESOMARK test is a manual enzyme-linked immunosorbent assay (ELISA) that works by identifying biomarkers called soluble mesothelin-related peptides (SMRP). These proteins are released into the bloodstream by malignant mesothelioma cells.
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. Mesothelioma is primarily caused by work-related asbestos exposure and has an average latency period of up to 50 years. It is estimated that more than 100 million people worldwide have been occupationally exposed to asbestos in the past five decades.
About MARF
MARF is a national nonprofit organization dedicated to eradicating mesothelioma as a life-threatening disease. For more information, please visit www.marf.org.
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.
CONTACT:
Fujirebio Diagnostics, Inc. (FDI) by Dudnyk Public Relations Bob Linton, 267-532-1298 (office) 215-801-2771 (mobile)
Fujirebio Diagnostics Expands Commercial Availability of
First Blood Test for Mesothelioma
Announces Distribution Agreement with Cisbio international to Bring MESOMARK™ to Europe
MALVERN, Pa. and Bagnols-sur-Cèze, France – April 14, 2005 – Fujirebio Diagnostics, Inc. (FDI), a world-leader in oncology testing, and Cisbio international, a French biotechnology company, today announced a distribution agreement for European distribution of FDI’s new blood test for mesothelioma – MESOMARK™. This agreement, the second for FDI, continues the worldwide commercial rollout of MESOMARK. Earlier this year, FDI launched MESOMARK in Australia where the company signed a contract with an Australian-based distributor.
“We are pleased to join with Cisbio international to introduce MESOMARK in Europe,” said Paul Touhey, president and COO for Fujirebio Diagnostics. “This agreement, combined with our recent announcement in Australia, further demonstrates FDI’s commitment to bring new, innovative and noninvasive diagnostic technologies to the world.”
“The inclusion of a highly innovative cancer diagnostic like MESOMARK into our portfolio helps us maintain our leadership position in tumor markers in Europe,” commented Berthold Baldus, managing director of Cisbio international. “We are proud of this important partnership with Fujirebio Diagnostics.”
Mesothelioma is a highly aggressive form of cancer 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 up to 75 years. Over 100 million people worldwide have been occupationally exposed to asbestos in the past five decades. It is estimated that 10,000 new cases are diagnosed each year among industrialized countries, and 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.
MESOMARK, a manual enzyme-linked immunosorbent assay (ELISA) for managing mesothelioma, works by identifying a group of molecular markers called soluble mesothelin-related proteins (SMRP). These proteins are released into the bloodstream by mesothelioma cells. Because SMRPs can be elevated for several years before an actual diagnosis of mesothelioma can be made, MESOMARK will help in the routine monitoring of asbestos exposed individuals who are at greatest risk for developing mesothelioma.
About Cisbio international
Cisbio international develops, manufactures and markets diagnostic assays for the quantification of tumor markers and other biomarkers in clinical biology. In addition, Cisbio international is an established developer of technologies that are used in assay development and drug screening procedures to enhance drug discovery. The company produces a selection of biological reagents and methods used by pharmaceutical and biotechnology companies, as well as contract research organizations (CROs). Cisbio international is a wholly-owned subsidiary of Schering S.A.
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.
Fujirebio Diagnostics Launches First Blood Test for Mesothelioma
Vital Diagnostics to Make Test Commercially Available in Australia
MALVERN, Pa. – March 3, 2005 – Fujirebio Diagnostics, Inc. (FDI), a world-leader in oncology testing, today announced that it has signed a distributor agreement with Australian-based Vital Diagnostics for its new blood test for mesothelioma – MESOMARKTM. The agreement marks the beginning of the company’s commercial roll-out of MESOMARK, which is now available for the first time in Australia.
“The launch of MESOMARK is a significant event for Fujirebio Diagnostics and greatly enhances our product portfolio, underscoring our commitment to commercialize high quality diagnostic tools that improve cancer patient care,” said Dr. Jeffrey Allard, vice-president and chief scientific officer at FDI. “MESOMARK is the first in-vitro diagnostic test for patients with mesothelioma and has the potential to improve survival rates and quality of life for patients with this aggressive and often fatal disease.”
Mesothelioma is a rare form of cancer in which fluid accumulates between the lining of the lungs and chest cavity. It is primarily caused by work-related asbestos exposure and has a latency period of up to 75 years. It is estimated that 10,000 new cases are diagnosed each year among industrialized countries.
MESOMARK is a manual enzyme-linked immunosorbent assay (ELISA) for managing mesothelioma. It works by identifying a group of molecular markers called soluble mesothelin-related proteins (SMRP), which are released into the blood-stream by mesothelioma cells.
Because SMRPs can be elevated for several years before an actual diagnosis of mesothelioma can be made, MESOMARK will help in the routine monitoring of asbestos exposed individuals who are at greatest risk for developing mesothelioma.
Co-inventor of the technology, Dr. Ingegerd Hellstrom, said, “I am pleased that Fujirebio Diagnostics has delivered this important diagnostic tool to the clinical community. While mesothelioma is a rare disease, it is often rapidly fatal. This test may one day lead to detection of mesothelioma at an early and potentially curable stage.”
About Vital Diagnostics
Vital Diagnostics, formed as Clinical Data in February 1993, is a leading independent niche marketer of laboratory diagnostics and instrumentation to the Australasian diagnostics market. The company is a majority owned subsidiary of Clinical Data, Inc. (NASDAQ: CLDA). Vital Diagnostics promotes its products in the Australasian market utilizing key account managers based in Auckland, Sydney and Melbourne, and is able to provide comprehensive applications and product support for all of the products it distributes. Vital Diagnostics is an active member of the Medical Industry Association of Australia (www.miaa.org.au). It has a diverse customer base in both medical and scientific laboratories.
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.
Fujirebio Diagnostics Expands Commercial Availability of First Blood Test for Mesothelioma: Announces Distribution Agreement with Cisbio international to Bring MESOMARK™ to Europe
MALVERN, Pa. and Bagnols-sur-Cèze, France – Apr.14/ -- Fujirebio Diagnostics, Inc. (FDI), a world-leader in oncology testing, and Cisbio international, a French biotechnology company, today announced a distribution agreement for European distribution of FDI’s new blood test for mesothelioma – MESOMARK™. This agreement, the second for FDI, continues the worldwide commercial rollout of MESOMARK. Earlier this year, FDI launched MESOMARK in Australia where the company signed a contract with an Australian-based distributor.
“We are pleased to join with Cisbio international to introduce MESOMARK in Europe,” said Paul Touhey, president and COO for Fujirebio Diagnostics. “This agreement, combined with our recent announcement in Australia, further demonstrates FDI’s commitment to bring new, innovative and noninvasive diagnostic technologies to the world.”
“The inclusion of a highly innovative cancer diagnostic like MESOMARK into our portfolio helps us maintain our leadership position in tumor markers in Europe,” commented Berthold Baldus, managing director of Cisbio international. “We are proud of this important partnership with Fujirebio Diagnostics.”
Mesothelioma is a highly aggressive form of cancer 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 up to 75 years. Over 100 million people worldwide have been occupationally exposed to asbestos in the past five decades. It is estimated that 10,000 new cases are diagnosed each year among industrialized countries, and 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.
MESOMARK, a manual enzyme-linked immunosorbent assay (ELISA) for managing mesothelioma, works by identifying a group of molecular markers called soluble mesothelinrelated proteins (SMRP). These proteins are released into the bloodstream by mesothelioma cells. Because SMRPs can be elevated for several years before an actual diagnosis of mesothelioma can be made, MESOMARK will help in the routine monitoring of asbestos exposed individuals who are at greatest risk for developing mesothelioma.
About Cisbio international
Cisbio international develops, manufactures and markets diagnostic assays for the quantification of tumor markers and other biomarkers in clinical biology. In addition, Cisbio international is an established developer of technologies that are used in assay development and drug screening procedures to enhance drug discovery. The company produces a selection of biological reagents and methods used by pharmaceutical and biotechnology companies, as well as contract research organizations (CROs). Cisbio international is a wholly-owned subsidiary of Schering S.A.
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.
SEATTLE, WA - November 15, 2003 Researchers at the Pacific Northwest Research Institute (PNRI) have reported the development of a blood test for mesothelioma, a highly aggressive lung cancer caused by asbestos exposure.
A PNRI team led by Dr. Ingegerd Hellstrom, and an Australian team, led by Dr. Bruce Robinson, of the University of Western Australia, conducted the research, which appears in the November 15th issue of Lancet. The new test promises a simple technique for diagnosing and monitoring mesothelioma early in its progress, when therapy is more likely to be successful. Fujirebio Diagnostics, Inc. (FDI) of Malvern, PA, a leading oncology diagnostic company, has acquired an exclusive license from PNRI to develop a commercial test for worldwide distribution.
According to Hellstrom, mesothelioma cells release distinctive molecular markers, SMR (soluble mesothelin-related proteins), into the blood stream. Hellstrom and her colleagues have identified this group of markers and have developed a test to detect them with great specificity.
In blood samples gathered from 273 individuals, researchers found that 84% of those with mesothelioma exhibited high levels of SMR. Only 1.9% of those with other forms of cancer or lung disease had any increased SMR, and patients who were healthy and had not been exposed to asbestos showed no biomarker increase.
"This is a very important breakthrough in the diagnosis and treatment of mesothelioma," Hellstrom explains. "Currently, no blood test exists to detect this cancer and the new biomarker will help doctors see the disease that so far has required much more complicated and expensive tests, and that even then has often gone undetected."
Commentary by MARF Science Advisory Board Chairman Dr. Harvey Pass:
The data from Robinson regarding SMR and mesothelioma1 could not only prove to be of paramount importance in the management of this orphan disease, but also could be a "posterchild" for how intuition, luck, and staying "au courant" with new technologies can translate into breathtaking discoveries. Our laboratory at the NIH was fortunate enough to collaborate with Dr. Pastan when he noted that monoclonal antibody K1 discriminated mesotheliomas from lung cancers2, and Dr. Pastan went on to characterize the antigen as mesothelin. Mesothelin has also served as a target for Phase I Clinical Trials. Remarkably, the ELISA by the Hellstroms did not originate in mesothelioma patients but in ovarian cancer individuals3, and because of Dr. Robinson's "intuition," this test could be a potential breakthrough for mesothelioma (and other mesothelin expressing tumors like ovarian and pancreas) patients.
Mesothelioma is more than just an orphan disease with a poor prognosis. It has social and economic implications, which have confounded both the United States and Western Europe, and in the future could become problematic in developing nations. That's the bad news. The good news, however, is that novel studies with investigating carcinogenic mechanisms, molecular prognostication and classification, and chemotherapies with encouraging response rates are being reported4. This is where "luck" comes into the picture because the time is perfect for the development of a sensitive and specific marker, which complements the advances in molecular biology and treatment for mesothelioma victims.
The assay needs refinement: the ELISA must be able to measure SMR protein in levels, which approach pg/ml, not as optical density units, and this development will only make the SMR levels more clinically relevant and be able to establish true baseline levels for various populations. Moreover, the data from Robinson need to obviously be validated in larger, prospective trials, and such trials involving institutions in the US, Europe, and in Australia are in the planning stages. These studies must investigate whether SMR is a prognostic marker for diagnosed mesothelioma as well as whether it can be used to discriminate mesothelioma from other pleural conditions. Of equal importance will be studies, which are able to longitudinally correlate the mesothelin levels with treatment effects, either from surgery, chemotherapy, and or radiation therapy. To have a marker, which predicts response to therapy or progression on is now relevant with mesothelioma since there now more options for relapsed patients. Finally, large archives of specimens from high-risk for mesothelioma asbestos exposed individuals will tell investigators whether SMR elevations can actually predate the development of mesothelioma, and, at least, guide the clinician to a compulsive workup in the SMR elevated, radiolographically occult high-risk client.
A potential marker like SMR may unmask an even greater epidemic of stricken patients than we think, and with the publication of a possible genetic link to the disease5, as well as the fallout from tragedies such as September 11, mesothelioma is even more than ever a global problem. Hence, the medical community must now stay "au courant" with mesothelioma.
Harvey I. Pass MD
Professor of Oncology and Surgery
Karmanos Cancer Institute/Wayne State University
Detroit, Michigan USA
Chairman, Scientific Advisory Board
Mesothelioma Applied Research Foundation (MARF)
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