Fujirebio Inc., a consolidated subsidiary of Miraca Holdings Inc., (Head office: Shinjuku-ku, Tokyo, President and CEO: Yoshihiro Ashihara, hereinafter “Fujirebio” or “the Company”) announced today that it has entered into an agreement with US-based Janssen Pharmaceuticals, Inc. (hereinafter “Janssen”) to develop and commercialize an AMYLOID β 42/40 RATIO assay. The assay, which will run on the fully-automated chemiluminescent enzyme immunoassay system, the Lumipulse® G series, is intended to help identify patients who may benefit from treatment with Janssen’s new investigational oral BACE inhibitor, atabecestat. Atabecestat is currently being studied for the slowing of cognitive decline in individuals who are identified by biomarkers to be progressing to Alzheimer’s dementia.1
Alzheimer’s Disease is a highly prevalent, chronic, progressive condition affecting tens of millions of people worldwide with numbers expected to grow unrelentingly as populations age.2 Without disease- delaying therapies, the impact of Alzheimer’s Disease will be socially and economically devastating because people with Alzheimer’s Disease ultimately require continuous care. Emerging science indicates that the disease starts years before Alzheimer’s dementia is evident, making it important to be able to recognize and treat early in the disease process, before cognitive symptoms are obvious.3
Fujirebio owns diagnostic products to aid in the management of Alzheimer’s disease, such as the ELISA-based INNOTEST® assay, which was launched by its EU subsidiary, Fujirebio Europe N.V. more than 20 years ago. In 2017, the Company also launched fully-automated tests, β-Amyloid 1-42 and Total TAU assays specialized for its LUMIPULSE G immunoassay system.
With this agreement, we look forward to building upon our extensive experience in assay development to support new options for the diagnosis and treatment of Alzheimer’s disease.
Founded in 1950, Fujirebio Inc. is an international leading diagnostic supplier, a part of Miraca Group, Japan’s leading healthcare group with its focus on clinical laboratory testing services and products. Fujirebio is specialized in development, commercialization, import and export of diagnostic reagent and instruments. For more about Fujirebio, visit http://www.fujirebio.co.jp/.
- An Efficacy and Safety Study of JNJ-54861911 in Participants Who Are Asymptomatic at Risk for Developing Alzheimer's Dementia (EARLY). Available at: https://clinicaltrials.gov/ct2/show/NCT02569398
- World Alzheimer Report 2015: The Global Impact of Dementia. Available at: https://www.alz.co.uk/research/world-report-2015
- Dubois, Bruno et al. Preclinical Alzheimer's disease: Definition, natural history, and diagnostic criteria. Alzheimer's & Dementia: The Journal of the Alzheimer's Association , Volume 12 , Issue 3 , 292 – 323.