Gent, Belgium: September 12 2014 - Fujirebio Europe today released a series of specialized assays for its chemiluminescent enzyme immunoassay (CLEIA) system, the LUMIPULSE® G1200, dedicated to the diagnosis and monitoring of HBV infection and the treatment of HBV patients. The HBV panel notably includes an entirely new tool in HBV testing, the Lumipulse® G HBcrAg, a unique serological marker (available as a Research Use Only test) correlated with cccDNA for improved monitoring of patients under treatment. This panel release consolidates the company’s solid position in the market of specialized HBV testing, already held for many years with the widely used INNO-LiPA® HBV test range.
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“We are very excited about the release of these new HBV infection screening assays for the LUMIPULSE® G analyzer; this panel is a fine result of our extensive in-house experience and combined know-how in the field of HBV testing and immunoassays.”, said Christiaan De Wilde, CEO of Fujirebio Europe. “Our Lumipulse® G HBsAg Quant assay has the highest sensitivity and best precision of all commercially available HBsAg quantitative assays on the market today. This is a step forward in the determination of HBsAg levels and means largely improved patient monitoring. Furthermore, the Lumipulse® G HBcrAg assay is a truly unique and novel marker, only available on our LUMIPULSE® G platform.”
These products are not available in the USA and in Canada.
About screening of HBV infection
Screening of HBV-infection is performed with a set of standard serological markers. However, advancements are still being made in both treatment options as well as in the monitoring of patients infected and treated for chronic HBV. Since a couple of years quantification of HBsAg is introduced for the follow-up of patients allowing an actual measurement of the levels of hepatitis B surface antigen as the indicator of active infection and a means to monitor the response to therapy.
An additional marker developed for the monitoring of patients under treatment is HBcrAg. This novel marker is a combination of different types of antigen proteins: HBcAg, HBeAg and p22cr and has shown to be correlated with cccDNA and is therefore a marker for the replication of the virus. This marker is already being utilized in Japan today to decide possible discontinuation of treatment with nucleos(t)ide analogues.
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.