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Fujirebio Diagnostics to Market Microtiter Format Assays for Five Life-Threatening Cancers
MALVERN, Pa January 11, 2002

Assays Derived from 'Gold Standard' Antibodies for Ovarian, Prostate, Breast, Gastric and Pancreatic Cancers to be Available in Markets Outside the U.S.

Fujirebio Diagnostics, Inc. (FDI), formerly known as Centocor Diagnostics, a leading diagnostics company and manufacturer of diagnostic assays for early detection of cancer recurrence, announced today that it would begin marketing a new line of six enzyme immunoassays (EIAs) in microtiter format. The innovative new EIAs will be based on the same "gold standard" antibodies utilized in the Fujirebio Diagnostics Radioimmunoassays (RIA). The assays will be available in Southeast Asia in Q1 2002 and later launched in Latin America, the Middle East, and Eastern Europe. The assays were co-developed with Trinity Biotech, an international medical diagnostics company.

The new EIAs will target ovarian cancer (CA 125II(TM)), breast cancer (CA15-3®), pancreatic cancer (CA19-9(TM)), gastric cancer (CA72-4®), and prostate cancer (Total PSA and Free PSA). The markers will be available in 96-well microtiter format, utilizing coated microwell strips, to provide laboratories with manual or automated options for greater flexibility. The EIA product line is standardized and clinically correlated to the "gold standard" RIA assays which are supported with more than 5,000 peer-reviewed articles that give it an extensive history and database of clinical studies, research and clinical use.

"The additions to our product line will provide the medical community with more flexibility for choosing between assay formats," said Aris Petropoulos, President and Chief Operating Officer of FDI. He noted that the EIA assays provide the same important clinical attributes associated with FDI's RIA product line, but extend cancer detection capabilities to laboratories that in the past could not use RIAs.

"In many parts of the world, RIAs for these life-threatening cancers are not available because their radioactive elements cannot be shipped or because local laboratories cannot run them," Mr. Petropoulos said. "By offering the microtiter format, we are making early detection of recurrent cancer available to people around the world, even in remote localities."

Trinity Biotech (Nasdaq: TRIB - news), an Irish- and U.S.-based company that specializes in the development, manufacture and marketing of diagnostic products which utilize immunoassay technologies, will co-manufacture the assays with FDI. The assays will be marketed by Fujirebio Diagnostics under the FDI label. Trinity markets over 120 products through distributors in 80 countries.

Fujirebio Diagnostics, formerly Centocor Diagnostics, is a premier oncology diagnostics company and the industry leader in tumor marker assays. The company, which has 20 years' experience in the diagnostic industry, specializes in the clinical development, manufacturing and marketing of in-vitro diagnostic assays.

SOURCE: Fujirebio Diagnostics, Inc.

 
 


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