First-ever Blood Test for Mesothelioma Being Developed

Asbestos Cancer Breakthrough Reported by Pacific Northwest Research Institute

SEATTLE, Nov. 13, 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."

Fujirebio is in the process of initiating the clinical development and commercialization of the mesothelioma test. Dr. Daniel O'Shannessy, FDI's Chief Scientific Officer, says that this new assay "will provide, for the very first time, a highly effective way of tracking disease progression through noninvasive means."

According to Robinson, from whose patients in Australia the blood samples were drawn, the new research also shows that SMR can be elevated in serum up to several years before actual diagnosis of mesothelioma. "The test may thus prove helpful," Robinson says, "for screening asbestos-exposed individuals for early evidence of mesothelioma."

Pacific Northwest Research Institute (PNRI) is a private non-profit biomedical and clinical research laboratory in Seattle, focusing on the prevention and cure of diabetes and cancer. PNRI conducts research in tumor immunology, autoimmune disease, growth factor and metabolic signal transduction pathways, oxidative stress, and large-population screening for diabetes and cancer. The Institute is also participating in a pancreatic islet transplantation research program to treat patients with diabetes. Major emphases of the Hellstrom laboratory at PNRI are on early detection of ovarian, breast, and lung cancers and the development of vaccines for therapeutic purposes. For more information, see www.pnri.org.

Fujirebio Diagnostics, Inc. (FDI), is a premier diagnostics company and the industry leader in Tumor Marker assays specializing in the clinical development, manufacturing and commercialization of in vitro diagnostic products for the management of human disease states with an emphasis in Oncology. The company, formerly known as Centocor Diagnostics, was acquired by Fujirebio, Inc. of Tokyo, Japan in November 1998. FDI utilizes its worldwide distribution network to enable access by physicians and patients to its diagnostic products.