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FDI Relocates Key Operations to Expanded, State-of-the-Art Facility.


Business Editors

MALVERN, Pa.--(BUSINESS WIRE)--April 19, 2004

Fujirebio Diagnostics, Inc. (FDI FDI

See: Foreign direct investment
), a premier diagnostics company with an emphasis in oncology, has relocated its manufacturing operations to a new and expanded facility at its 201 Great Valley Parkway location. The move enables FDI, which produces tumor markers Tumor Markers Definition

Tumor markers are measurable biochemicals that are associated with a malignancy. They are either produced by tumor cells (tumor-derived) or by the body in response to tumor cells (tumor-associated).
 considered the "gold standard" in the diagnostics industry, to combine its administrative, R&D and manufacturing functions under one roof, supporting the company's next phase of growth.

FDI president/COO Paul Touhey explains, "The move is helping us to more effectively manage our manufacturing operations, as well as the development of new products currently in the pipeline."

The move continues a process of integration at FDI that has been ongoing since Tokyo-based Fujirebio, Inc., purchased the company from Centocor in 1998. Formerly Centocor Diagnostics, FDI produces in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment.

in vi·tro
adj.
In an artificial environment outside a living organism.
 diagnostic products for a variety of human diseases, with a focus on various types of cancer. FDI's current product portfolio includes some of the most trusted names in the industry including CA 125 II(TM) (ovarian cancer ovarian cancer

Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast
), CA 15-3(R) (breast cancer), CA 19-9(TM) (pancreatic cancer), CA 72-4(R)(1) (gastrointestinal cancer) and CYFRA 21-1(TM)(1) (lung cancer).

The expanded facilities include approximately 75,000 square feet of administrative, R&D and manufacturing space. Facility operations are conducted according to ISO (1) See ISO speed.

(2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI.
 9001/13485 and FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 GMP GMP (guanosine monophosphate): see guanine.  compliant Quality Systems.

About FDI

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. For more information on FDI, please call 610-240-3800 or visit www.fdi.com.

CA 125 II, CA 19-9 and CYFRA 21-1 are trademarks and CA 15-3 and CA 72-4 are registered trademarks of Fujirebio Diagnostics, Inc.

(1) Not for distribution in the United States.
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Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Apr 19, 2004
Words:350
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