Gent, Belgium: July 16, 2017 – Fujirebio Europe today announced the CE-marking of the Lumipulse G Total Tau assay for its fully automated LUMIPULSE immunoassay systems. This CLEIA (chemiluminescent enzyme immunoassay) kit allows for the quantitative determination of total Tau in human cerebrospinal fluid within just 35 minutes.
The Lumipulse G Total Tau assay is based upon Fujirebio’s well established, pioneering INNOTEST® ELISA, the first commercial neurodegeneration testing kit launched in 1995. Fujirebio has a long company history of developing automated CLEIA tests dating back to the first generation of LUMIPULSE analyzers in 1992.
The Lumipulse G Total Tau assay is Fujirebio’s second fully automated test for Alzheimer’s disease, having launched its Lumipulse G β-Amyloid 1-42 assay in January this year.
About Alzheimer’s disease
Alzheimer’s disease (AD) is a widespread condition that occurs in 50% to 60% of individuals suffering from dementia. Globally, it is one of the most disabling and burdensome of health conditions and its incidence is rising rapidly due to increasing life expectancy. From the age of 65 the incidence of AD doubles every five years (from around 2-3% to no less than 35-40% after 85 years of age). This public health care issue translates into 46.8 million of people suffering from the condition worldwide today. The number is set to reach 74.7 million in 2030, surging to 131.5 million in 2050.1
The challenge of early, accurate diagnosis
Alzheimer’s disease starts silently, and develops several years before clinical symptoms appear. Until recently, it has been difficult for physicians to predict which individuals with memory problems will eventually develop AD, and which ones will not. Even when clinical symptoms of dementia are present, the clinical diagnosis of AD is reported to be correct in only 65% to 96% of the time.2 Accuracy rates tend to be especially low in the earlier stages of AD. New diagnostic tools to help detect AD as early as possible, and make early diagnosis with the highest level of certainty are of fundamental importance for both physicians and the patients and families involved. This is because memory complaints can result from several causes and may be reversible. In its early stages, it is especially difficult to discriminate AD from any other type of dementia, depression, or even normal aging.
Another reason that early detection tools are urgently needed is because it is believed that the treatment of diseases such as AD ideally should begin as soon as possible. Pharmaceutical companies trying to develop new AD treatments need reliable tests to establish clear-cut treatment groups, and means of monitoring the effectiveness of candidate treatments.3
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Fujirebio is a global leader in the field of high quality in vitro diagnostics (IVD) testing. It has more than 50 years’ accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products.
Founded in 1950 in Tokyo, Japan, Fujirebio has over the years concluded a number of successful acquisitions of best-in-class IVD companies. Examples include Centocor Diagnostics in 1998, CanAg Diagnostics in 2006 and Innogenetics in 2010. Today, Fujirebio’s global presence includes offices in the United States, Latin America, Europe and Asia as well as a vast international distribution network.
Fujirebio has a strong and long-lasting tradition of collaborating with experts in the worldwide clinical community in the development of high-quality routine and truly novel biomarkers that cover a variety of disease states. Its IVD product lines span the range from specialized manual and automated testing to fully automated routine clinical laboratory testing solutions.
Fujirebio is today a member of Miraca Group (Miraca Holdings Inc. listed on the Tokyo Stock Exchange – TYO: 4544) and employs more than 1.200 people in Asia, Europe and America.
World Alzheimer Report 2015
Dubois et al, Lancet Neurology 2007; 6(8):734-46.
Lleo et al, Nat Rev Neurol 2015; 11:41-55.