Fujirebio Diagnostics, Inc.

MALVERN, Pa. & TOKYO--( BUSINESS WIRE )--Fujirebio today announced that its wholly-owned subsidiary Fujirebio Diagnostics, Inc. has filed its Lumipulse ® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test with the U.S. Food and Drug Administration (FDA). The new plasma test is expected to be the first commercially available blood-based IVD test in the U.S. to help in the assessment of Alzheimer’s disease (AD). The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio, which received Breakthrough Device Designation from the FDA, is an IVD test using measurable pTau 217 and β-Amyloid 1-42 concentrations found in human plasma. The test combines these concentrations into a numerical ratio of pTau 217/β-Amyloid 1-42 to identify patients with amyloid pathology associated with AD. β-Amyloid neuritic plaque pathology in the brain is believed to contribute to the loss of cognitive function that characterizes AD. AD is a devastating condition that afflicts more than 6 million Americans and is a leading cause of disability and death. Access to reliable diagnostic tools is currently limited. Diagnosis involves a variety of subjective measures and costly or invasive procedures, such as amyloid positron emission tomography (PET) scans and cerebral spinal fluid (CSF) tests. As a result, many patients are not diagnosed until their disease has advanced, limiting the benefits of available treatment options. The Lumipulse pTau 217/β-Amyloid 1-42 Plasma Ratio test uses Fujirebio’s fully automated Lumipulse G1200 instrument system, which is widely available in clinical laboratories throughout the U.S. The new ratio test complements the Lumipulse G β-Amyloid Ratio (1-42/1-40), authorized by the FDA for use in CSF in May 2022. “The lack of effective and accessible diagnostics for AD contributes to its late diagnosis and inadequate treatment,” says Monte Wiltse, President and CEO at Fujirebio Diagnostics, Inc. “We designed our Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test to help physicians and patients with signs and symptoms of cognitive decline obtain an AD diagnosis much earlier when interventions are more effective. An early and accurate diagnosis will also facilitate the development of new drug therapies, which are urgently needed as the prevalence of AD increases with a rapidly aging population globally. As part of our worldwide commitment to improving the diagnosis and treatment of AD, Fujirebio is developing additional assays, which will increase the availability of diagnostic tools and expand the foundation for early, more effective treatment.” About Fujirebio Fujirebio, a member of H.U. Group Holdings Inc., 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. Fujirebio was the first company to develop and market CSF biomarkers under the Innogenetics brand over 25 years ago. Fujirebio remains the only company with such a comprehensive line-up of manual and fully automated neurodegenerative disease assays and consistently partners with organizations and clinical experts across the world to develop new pathways for earlier, easier and more complete neurodegenerative diagnostic tools. More information can be found at www.fujirebio.com/alzheimer . About Fujirebio Diagnostics, Inc. Fujirebio Diagnostics, Inc., a wholly-owned subsidiary of Fujirebio Holdings, Inc., is the premier cancer diagnostics company and the industry leader in cancer biomarker assays. The company pioneered and introduced the CA125 test, the first FDA-approved ovarian cancer biomarker, over 25 years ago. Fujirebio Diagnostics specializes in the clinical development, manufacturing and commercialization of in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology. For more information about Fujirebio Diagnostics, please call +1 610-240-3800 or visit us at www.fujirebio.com .

The collaboration aims to identify and develop accessible, minimally invasive blood-based biomarkers specific for tau pathology in the brainThese tools have the potential to be used to stratify patients or monitor treatment response for a new generation of future therapies impacting tau pathology in Alzheimer’s disease CAMBRIDGE, Mass. and BREA, Calif. and TOKYO, July 30, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB), Beckman Coulter, Inc. and Fujirebio announced a collaboration to potentially identify and develop blood-based biomarkers for tau pathology in the brain and to potentially clinically advance and potentially commercialize new tests for tau pathology in Alzheimer’s disease (AD). The development of tau-specific blood-based biomarkers that can measure a patient’s tau burden could provide critical insights into the underlying pathological processes of AD and may help advance the development of a new generation of therapies impacting tau pathology. Through this collaboration, the companies will work to identify new blood-based biomarkers and advance known blood-based biomarkers for tau pathology in AD. The collaboration aims to develop and clinically advance new tools that measure brain tau pathology to potentially stratify patients or monitor treatment response in AD clinical trials. The collaboration has the potential to advance tau-specific blood-based biomarkers and diagnostic tools that could be used not only in clinical trials, but also in clinical practice to enable adoption of future therapies impacting tau pathology. “Stratifying and monitoring patients for tau pathology is a growing need for the next generation of Alzheimer's therapies, such as our pipeline of investigational tau-targeting therapies, including tau-directed ASO,” said Jane Grogan, Ph.D., Head of Research at Biogen. “Through this collaboration, we plan to leverage our deep scientific expertise in the development and use of biomarkers, combined with our partners’ capabilities in diagnostics, to potentially accelerate the development timeline for blood-based diagnostics that can measure a patient’s levels of tau pathology.” “Collaborative efforts between Biogen, Beckman Coulter and Fujirebio combine the strength of leading edge biomarker development with innovative potential treatments focused on the tauopathy aspect of neurodegeneration, driving us closer to effective solutions,” said Kathleen Orland, Senior Vice President, General Manager, Chemistry, and Immunoassay for Beckman Coulter Diagnostics. “Ensuring high quality neurological tests are broadly available through our global installed-base of analyzers, this collaboration with Biogen and Fujirebio underscores our commitment to working with leaders in neurodegenerative disease areas to bring fully automated, high throughput, blood-based Alzheimer's disease testing to the millions of patients who suffer from dementia worldwide.” “Blood-based biomarkers for tau pathology could advance the development and implementation of disease-modifying therapies for neurodegenerative disorders such as AD,” said Monte Wiltse, President & CEO of Fujirebio Diagnostics, Inc. “This partnership will further help us accelerate our efforts to develop novel neurodegenerative disease diagnostics and deliver them to laboratories and clinicians around the world via our global diagnostics partners, addressing the unmet medical need for blood-based biomarkers.” Under the terms of the collaboration, Biogen will provide Alzheimer's clinical study data and expertise in biomarker research to prioritize markers for tau pathology. Fujirebio and Beckman Coulter will be responsible for providing diagnostic development, manufacturing and commercialization. About BiogenFounded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - Facebook, LinkedIn, X, YouTube. About Beckman Coulter. Inc. A global leader in advanced diagnostics, Beckman Coulter has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 80 years. Our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time – and we do this by applying the power of science, technology and the passion and creativity of our teams. Our diagnostic solutions are used in complex clinical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. We exist to deliver smarter, faster diagnostic solutions that move the needle forward from what’s now to what’s next. We do this by accelerating care with an extensive clinical menu, scalable lab automation technologies, insightful clinical informatics, and lab performance services. Headquartered in Brea, Calif., Beckman Coulter has more than 11,000 global team members. 2024-13330. Follow and connect with Beckman Coulter via LinkedIn, X, and Facebook About Fujirebio Fujirebio, a member of H.U. Group Holdings Inc., 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. Fujirebio supplies new technology and novel diagnostic markers to the global Diagnostics industry through material supply, contract development and manufacturing. Fujirebio was the first company to develop and market CSF biomarkers under the Innogenetics brand over 25 years ago. Fujirebio remains the only company with such a comprehensive line-up of manual and fully automated neurodegenerative disease assays and consistently partners with organizations and clinical experts across the world to develop new pathways for earlier, easier and more complete neurodegenerative diagnostic tools. More information can be found at www.fujirebio.com/alzheimer. Biogen Safe Harbor This press release contains forward-looking statements, relating to: our strategy and plans; potential of, and expectations for, our commercial business and pipeline programs; capital allocation and investment strategy; clinical development programs, clinical trials, and data readouts and presentations; the potential for blood based AD biomarker tests; regulatory discussions, submissions, filings, and approvals; the potential benefits, safety, and efficacy of our and our collaboration with Beckman Coulter Diagnostics and Fujirebio;. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “potential,” “possible,” “prospect,” “will,” “would,” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our dependence on sales from our products; uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; failure to compete effectively; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks associated with current and potential future healthcare reforms; risks related to commercialization of biosimilars; failure to obtain, protect, and enforce our data, intellectual property, and other proprietary rights and the risks and uncertainties relating to intellectual property claims and challenges; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; risks relating to technology failures or breaches; problems with our manufacturing processes; risks relating to management, personnel and other organizational changes, including attracting and retaining personnel; failure to comply with legal and regulatory requirements; the risks of doing business internationally, including currency exchange rate fluctuations; risks relating to investment in our manufacturing capacity; risks relating to the distribution and sale by third parties of counterfeit or unfit versions of our products; risks relating to the use of social media and artificial intelligence based software for our business; results of operations, and financial condition; fluctuations in our operating results; risks related to investment in properties; risks relating to access to capital and credit markets; risks related to indebtedness; the market, interest, and credit risks associated with our investment portfolio; risks relating to share repurchase programs; change in control provisions in certain of our collaboration agreements; fluctuations in our effective tax rate; environmental risks; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements. MEDIA CONTACT(S):BiogenJack Cox+ 1 781 464 3260public.affairs@biogen.comBeckman Coulter DiagnosticsJeff Tarmy+ 1 617 467 7537jtarmy@beckman.comH.U. Group Holdings/FujirebioKazumi Kobayashi+ 81 3 6279 0884pr@hugp.comINVESTOR CONTACT(S):BiogenChuck Triano+1 781 464 2442IR@biogen.com H.U. Group Holdings/FujirebioHisashi Yamakawa+ 81 3 6279 0926ir@hugp.com

NORTH BETHESDA, Md.--( BUSINESS WIRE )--A new study, developed and launched by the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium , found some blood tests are accurate enough that they are suitable for clinical use and could replace spinal taps and brain scans in many patients with cognitive impairment. The study compared the accuracy of leading commercial blood tests in detecting amyloid plaques, a characteristic feature of Alzheimer’s. Some blood tests recently have been shown to identify the telltale brain changes of Alzheimer’s disease as accurately as established, more invasive methods, such as brain scans and cerebrospinal fluid tests. Yet, their widespread use in clinical practice has been limited by a lack of robust data validating their accuracy. The study results will be presented in an oral session at the Alzheimer’s Association International Conference (AAIC) in Philadelphia. The detailed study findings are available on the MedRxiv pre-print server. “The recent approvals of new anti-amyloid drugs—and the many treatments being studied in clinical trials—underscore the pressing need for more accessible, less invasive testing for early detection of Alzheimer’s,” said Julie Gerberding, MD, MPH, President and CEO of the FNIH. “This collaborative research effort has resulted in a rich dataset that is freely available to the scientific community and moves us closer to our goal—accelerating the development of Alzheimer’s diagnostic tools and therapeutic options for the millions of people who suffer from this disease.” The study confirmed that some blood tests have accuracy similar to established cerebrospinal fluid tests, which require a spinal tap, in determining the presence of amyloid plaques as measured by positron emission tomography (PET) scans. The project team evaluated commercially available tests developed by ALZpath, C 2 N Diagnostics, Fujirebio Diagnostics, Janssen, Quanterix, and Roche Diagnostics. Using blood samples from the Alzheimer’s Disease Neuroimaging Initiative (ADNI), the team assessed the ability of these tests to accurately detect amyloid plaques and tau tangles, decrease in brain volume, and clinical dementia symptoms. The study also offered further confirmation that blood tests measuring levels of the protein p-tau217 are the most accurate in determining the presence and amount of amyloid plaques. In addition to their use in clinical diagnosis, the Alzheimer’s blood tests could speed future drug development by helping researchers select the optimal participants for clinical trials. “Many Alzheimer’s blood tests are now clinically available. Some are highly accurate, while others are little better than flipping a coin. Doctors need to know which tests can be trusted,” said Suzanne Schindler, MD, PhD, a clinical neurologist and the Fluid Biomarker Core Leader at Washington University School of Medicine in St. Louis, and a member of the FNIH project team. “This study generated an incredible dataset that is easily accessible to researchers, who can scrutinize our findings and also answer many more questions about blood tests for Alzheimer’s.” An important goal of current research is evaluating whether certain treatments may prevent or slow the onset of cognitive decline in patients with early Alzheimer’s brain changes. The FNIH study found that some blood tests accurately detected low levels of brain amyloid in people without cognitive impairment, and the FNIH project team is performing additional analyses to evaluate how well these blood tests can predict the progression of Alzheimer’s disease over time, including the likelihood of pre-symptomatic individuals eventually developing cognitive symptoms. Data from this study are available via ADNI for investigators interested in further studying the performance of these tests as well as evaluating other scientific questions, such as the effects of age, sex, genetics, medical conditions, race, and the social determinants of health on amyloid pathology. AAIC Presentation Details “Head-to-head evaluation of leading blood tests for amyloid pathology,” presented by Dr. Kellen Petersen on Tuesday, July 30, at 2:28 p.m. EDT in 118 ABC, Developing Topics Session 2, Pennsylvania Convention Center, Philadelphia. About the Biomarkers Consortium The Foundation for the National Institutes of Health’s Biomarkers Consortium leads cross-sector efforts to validate and qualify biomarkers that accelerate the development of new therapeutics and health technologies. The core operations of the Biomarkers Consortium are supported through its contributing membership program, which includes the National Institutes of Health (NIH), the U.S. Food and Drug Administration, private industry, and not-for-profit organizations. For a list of partners supporting this study, see the project webpage . About the Foundation for the National Institutes of Health The Foundation for the National Institutes of Health (FNIH) builds public-private partnerships that connect leading biomedical scientists at the National Institutes of Health (NIH) with their counterparts in life sciences companies, academia, patient advocacy organizations, foundations, and regulatory agencies (including the Food and Drug Administration and European Medicines Agency). Through team science, the FNIH solves complex health challenges and accelerates breakthroughs for patients, regardless of who they are or what health threats they face. The FNIH contributes to the development of new therapies, diagnostics, and potential cures; advances global health and equity in care; and celebrates and helps train the next generations of scientists. Established by Congress in 1990 to support the mission of the NIH, the FNIH is a not-for-profit 501(c)(3) charitable organization. For more information about the FNIH, please visit fnih.org . Follow us on social media: LinkedIn , X , Facebook .