Fujirebio Diagnostics AB

P.O. Box 121 32, 402 42 Gothenburg
Elof Lindälvsgata 13, 414 58 Gothenburg

Telephone +46 31 857030
Fax +46 31 857040


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MEDICA 2016 hall map (Hall 3): stand B42

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MEDICA 2016 fairground map: Hall 3

Our range of products

Product categories

  • 03  Diagnostics
  • 03.02  Immunochemistry (Immunology)
  • 03.02.17  Tumor markers

Our products

Product category: Tumor markers


HE4 (WFDC2) is a promising new biomarker (it was first associated with the human epididymis). HE4 belongs to the family of whey acidic four-disulfide core (WFDC) proteins. Fujirebio Diagnostics, Inc. has developed an ELISA kit for the quantitative measurement of HE4 in patient blood.

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Product category: Tumor markers


The MESOMARK® test is the first in vitro diagnostic test for patients with mesothelioma.

Mesothelioma is a rare form of cancer in which fluid accumulates in the lungs and chest cavity. Mesothelioma can also be found in the lining of the pleural cavity of the abdomen. It is primarily caused by work-related asbestos exposure, and it is estimated that 10,000 new cases are diagnosed each year among industrialized countries. Malignant mesothelioma is an extremely aggressive disease with a poor prognosis.

The MESOMARK assay is a manual enzyme-linked immunosorbent assay for the quantitative measurement of Soluble Mesothelin-Related Peptides (SMRP). SMRP is a biomarker that is released into the bloodstream by mesothelioma cells. SMRP can be elevated years before an actual diagnosis of mesothelioma is made. By measuring the amount of SMRP present in the bloodstream, the MESOMARK assay will help physicians routinely monitor individuals with the greatest risk of developing mesothelioma due to asbestos exposure.

Please contact us at +46 3185 7030 or order@fdab.com for more information on the MESOMARK assay.

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Product category: Tumor markers

Manual Kits

Fujirebio Diagnostics, Inc. has over 20 years of experience in the manufacture and supply of manual kits for a range of disease states. Our products are supported bypeer-reviewed publications and are used in over 30 countries.

Our manual kits are available for research and clinical use. We offer manual enzyme immunoassay (EIA) kits for multiple biomarkers and disease states. Our antibodies are also available for research use and through license and supply agreements.

Our EIA kits are economical and provide the laboratory with the flexibility and high quality required today. In addition, our kits are easily accessible through our distribution network in over 30 countries.

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Product category: Tumor markers

Tumor Marker Control

From the company that brought you CA 125, CA 19-9, and CA 15-3, the "Gold Standard" IVD manufacturer for tumor marker reagents now brings you a multi-constituent Tumor Marker Control, exclusively including the novel biomarker HE4.

Laboratories can utilize the Fujirebio Diagnostics Tumor Marker Control as an independent internal quality control to monitor the performance of their tumor marker testing.

Tumor Marker Control:
The only available multi-constituent control containing the novel biomarker HE4
Contains clinically relevant proportions of FREE PSA and PSA-ACT
Contains medically relevant levels for HE4, AFP, CA 125, CA 15-3, CA 19-9, CEA, Ferritin, PSA, and Free PSA
Lyophilized, 100% human serum matrix
Reconstituted stability up to 60 days at <-20°C
Stable for up to 9 freeze/thaw cycles
Assayed values available for manual and automated methodologies
Reputation as a "high quality" IVD manufacturer, "gold standard" for tumor markers

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About us

Company details

Fujirebio Diagnostics, Inc. is a world leader in the production of in vitro diagnostics, and biomarkers. The name Fujirebio (pronounced Fuji-Ray-Bee-Oh) symbolizes restoration of health. Our parent company, Fujirebio, Inc., a leading healthcare company in Japan with a focus on diagnostics, acquired Fujirebio Diagnostics in 1998. In June 2006, CanAg Diagnostics of Sweden, now called Fujirebio Diagnostics AB joined Fujirebio Diagnostics to strengthen the company's product offerings, distribution network, and research and development capabilities. In April 2008, American Biological Technologies, Inc. became a part of Fujirebio Diagnostics. The expertise and capabilities of this site allow Fujirebio Diagnostics the versatility to continue to meet the needs of the diagnostics industry and our partners to enter the field of diagnostics outside of oncology, through the manufacture of calibrators and controls for many disease states.

Fujirebio Diagnostics specializes in the manufacturing of manual assay products, reagents and controls distributed throughout the U.S. and around the world, as well as custom-developed products for use through our worldwide network of distribution partners. With close to 65,000 square feet of manufacturing space between our U.S. headquarters in Malvern, PA, Seguin, TX, and Sweden, Fujirebio Diagnostics' proven manufacturing process has made us a global partner of choice among leading diagnostic companies.

Looking forward, we will remain committed in our efforts to deliver quality and value with products that have made us the standard of excellence in the industry and we will continue to use our resources to develop new, innovative products that aid healthcare professionals in the treatment of human disease.

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