18 Jun 2015 | Fujirebio Europe releases the Lumipulse® G HE4 assay dedicated to ovarian cancer therapy monitoring and as an aid in estimating the risk of epithelial ovarian cancer in women with pelvic mass

Gent, Belgium: June 18, 2015 - Fujirebio Europe today announced the release of its new Lumipulse G HE4 assay which will be available for testing on its CLEIA-based LUMIPULSE G systems, the LUMIPULSE G600II and the LUMIPULSE G1200. Lumipulse G HE4 is the first new biomarker for ovarian cancer management in more than 30 years1 after the initial launch by Fujirebio of the CA125 test (also available on the LUMIPULSE G series).

 “Diagnosis of the early signs of ovarian cancer is absolutely critical for a timely and adequate patient management and can be key for a patient’s survival.” said Christiaan De Wilde, CEO at Fujirebio Europe. “The HE4 assay from Fujirebio is already known to feature increased specificity for detection of ovarian cancer over that of CA125, the most used ovarian cancer biomarker, alone. I am very happy that Fujirebio now has made this differentiating test available for CLEIA based testing on our LUMIPULSE G systems. The combination of the new Lumipulse G HE4 kit and our Lumipulse G CA125 kit promises to set a new standard in ovarian cancer diagnostics.”

About HE4
Human epididymis protein 4 (HE4), a serum biomarker, is expressed in normal epithelial tissue and is detected in high levels in the serum of ovarian cancer patients. HE4 is a stable biomarker in which levels do not change in normal physiological conditions. More information can be found at

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About Fujirebio
Fujirebio is a leading international healthcare company with a strong focus on high quality in vitro diagnostics (IVD) testing solutions. Founded more than 60 years ago in Japan, the company is today recognized as the world-wide market leader in oncology for both routine and novel markers and has a strong reputation in Japan in infectious disease testing in hospitals, clinical labs and blood banks. Over the last 20 years Fujirebio has been committed to bringing solid and successful automated immunoassay testing solutions and state of the art chemiluminescent assay products to the market. Under the name Innogenetics (now Fujirebio Europe) the company has also been pioneering the field of molecular diagnostics and multiparameter testing. The company is today one of the world leaders in strip-based diagnostics solutions.

The product lines range from specialized manual testing to fully automated routine testing and they cover disease fields such as infectious, oncology, genetic testing, thyroid, fertility, tissue typing, neurodegeneration and bone.

Fujirebio is a subsidiary of Japan-based Miraca Holdings (listed in the Tokyo Stock Exchange - MRCHF) and counts more than 1.100 employees working in Asia, Europe and America, including subsidiaries. For more information about Fujirebio please visit www.fujirebio.com/english or www.fujirebio-europe.com.


  1. Diamandis E, et al. Cancer Biomarkers: Can we turn recent failures into success? J Natl Cancer Inst. 2010; 102-1-6.

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