Latest news with #Fujirebio
Yahoo
30-07-2025
- Health
- Yahoo
New Alzheimer's Clinical Guidelines Move Towards Replacing More Invasive Tools with Blood Tests; Pressing Need for Further Guidance Remains
Alzheimer's Drug Discovery Foundation calls for guidelines for FDA-approved blood tests to continue momentum toward precision medicine NEW YORK, July 30, 2025 /PRNewswire/ -- Expanding the use of Alzheimer's blood tests is crucial to usher in a new era of precision medicine and bring Alzheimer's disease into mainstream care. The new clinical practice guidelines for blood biomarkers announced today by the Alzheimer's Association represent a first step in this effort, but further direction is needed to address newly FDA-approved tests as the diagnostic landscape continues to evolve. "Replacing more invasive PET scans and CSF tests, when appropriate, with blood tests will be a major step toward the future we envision, where we can detect and diagnose Alzheimer's sooner, allowing for earlier intervention and even prevention," said Dr. Howard Fillit, Co-Founder and Chief Science Officer of the ADDF. "These guidelines signal progress, but with the science moving quickly, it's essential that clinical recommendations keep pace – especially with Fujirebio's blood test approved by the FDA and more to follow." The new guidelines are limited to specialty care, apply only to patients with cognitive impairment, and exclude several blood tests, including Fujirebio's. Still, they reflect critical momentum, recommending blood biomarkers with ≥90% sensitivity and specificity to replace more invasive and costly confirmatory tests like PET imaging or cerebrospinal fluid (CSF) testing during Alzheimer's diagnosis. As of now, only C2N's PrecivityAD2 test meets these requirements. Tests with ≥90% sensitivity and ≥75% specificity are recommended to be used for triage, with negative results ruling out Alzheimer's, while positive results should be confirmed with PET or CSF. While amyloid blood tests are a critical first step, the ADDF is focused on advancing next-generation biomarkers through its Diagnostics Accelerator (DxA) – a $100 million global initiative supported by the late Leonard A. Lauder, Bill Gates, Jeff Bezos, and other leading philanthropists – that reflect the broader biology of aging and align with today's robust drug pipeline where over 70% of drugs target non-amyloid pathways. "The future of Alzheimer's care lies in precision medicine. To get there, we need a full spectrum of validated biomarkers — and robust clinical guidelines to help providers use them effectively," added Dr. Fillit. "In the future, digital biomarkers and blood tests will be used side-by-side to detect the disease early, track its progression, and guide treatment based on each patient's unique biology." About The Alzheimer's Drug Discovery Foundation (ADDF)Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $370 million to fund 765 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 21 countries. To learn more, please visit: About the Diagnostics Accelerator (DxA)The Diagnostics Accelerator, created in July 2018, is a $100 million global research initiative from partners including ADDF Co-Founder Leonard A. Lauder, Bill Gates, Jeff Bezos, MacKenzie Scott, the Dolby family, the Charles and Helen Schwab Foundation, The Association for Frontotemporal Degeneration, among others, to develop novel biomarkers for the early detection of Alzheimer's disease and related dementias. This research initiative is dedicated to accelerating the development of affordable and accessible biomarkers to diagnose Alzheimer's disease and related dementias and advance the clinical development of more targeted treatments. Through translational research awards and access to consulting support from industry experts, this program will challenge, assist and fund the research community in both academia and industry to develop novel peripheral and digital biomarkers. View original content to download multimedia: SOURCE Alzheimer's Drug Discovery Foundation Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
14-07-2025
- Health
- Yahoo
Quest Diagnostics to Offer FDA-Cleared Fujirebio Blood Test for Alzheimer's Disease
Test to be available for clinical and research use as soon as this summer, building on Quest's pioneering blood-based AD-Detect™ product line for assessing symptomatic patients SECAUCUS, N.J., July 9, 2025 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, including advanced diagnostics for brain health, today announced it plans to offer laboratory testing based on the Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test from Fujirebio, a global leader in the field of high-quality IVD testing. Quest plans to make the test available to physicians and biopharmaceutical collaborators later this summer. The test is the first blood-based IVD test cleared by the U.S. Food and Drug Administration (FDA) to aid in identifying patients with amyloid pathology associated with Alzheimer's disease. It is designed to aid the clinical assessment of Alzheimer's disease in adult patients aged 50 years and older presenting at a specialized care setting with signs and symptoms of cognitive decline. Through its AD-Detect™ portfolio, Quest provides a suite of advanced lab-developed blood tests regulated under CLIA for assessing patients with cognitive impairment for Alzheimer's disease. The Fujirebio test offering extends this portfolio to include an FDA-cleared option for use in specialized care settings. "Our goal is to advance access to quality and innovative blood-based tests for Alzheimer's disease. Adding the Fujirebio test to our existing blood-based tests provides the many physicians we serve with another powerful option for assessing patients for Alzheimer's disease," said Kathleen Valentine, Vice President and General Manager, Neurology, Quest Diagnostics. "Blood-based testing can be less invasive and more convenient than traditional test methods. We are excited to leverage our expansive network of patient service centers to broaden access to the Fujirebio innovation to help more at-risk individuals gain access to the insights they need sooner." In a clinical study population of 499 patients, which closely mirrors US demographics, and when applying a dual cut point, the FDA-cleared test demonstrated a positive predictive value (PPV) of 92% and a negative predictive value (NPV) of 97%, with 20% of patients uncertain to have amyloid pathology, thus requiring further testing. Quest will showcase its complete line up of Alzheimer's and other neurological test innovations at this year's Alzheimer's Association International Conference (AAIC) in Toronto from July 27-31. "As brain health and Alzheimer's disease interventions continue to evolve, diagnosing patients earlier, when interventions can be most effective, is critical," said Michael Racke, MD, a board-certified neurologist and Medical Director of Neurology, Quest Diagnostics. "We are constantly looking for ways to help physicians and patients make the most informed decisions, and this new addition to our test menu will aid that goal." While amyloid PET imaging and cerebral spinal fluid testing are established methods for aiding the diagnosis of Alzheimer's disease, they are significantly more expensive, invasive and specialist-dependent than blood-based tests. With a physician's order, patients can conveniently provide a blood draw for testing for the Fujirebio test and any of the AD-Detect™ tests through Quest's network of patient sites. Quest maintains approximately 8,000 patient access points, including an extensive patient service center network of approximately 2,000 locations in the U.S., as well as phlebotomists in physician offices and mobile phlebotomy services. Specimens will be transported for testing to Quest's state-of-the-art laboratory in San Juan Capistrano, California. Nearly 7 million Americans have Alzheimer's, the most prevalent dementia, a number projected to reach 14 million by 2060. Approximately 12-18% of adults over the age of sixty are living with mild cognitive impairment, a potential sign of AD. Seventy-seven percent of physicians say new therapies will transform Alzheimer's into a chronic, manageable disease, and 94% of physicians say blood tests would be more cost effective for the healthcare system compared to more invasive methods of detection (e.g., lumbar puncture, imaging studies) according to a special report from Quest. Quest is committed to developing and offering innovative advanced diagnostics to aid in evaluating Alzheimer's disease and other brain diseases. For more information, visit About Quest DiagnosticsQuest Diagnostics works across the healthcare ecosystem to create a healthier world, one life at a time. We provide diagnostic insights from the results of our laboratory testing to empower people, physicians and organizations to take action to improve health outcomes. Derived from one of the world's largest databases of de-identifiable clinical lab results, Quest's diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our nearly 55,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives and create a healthier world. View original content to download multimedia: SOURCE Quest Diagnostics
Business Upturn
23-06-2025
- Business
- Business Upturn
Fujirebio Acquires Plasma Services Group and Strengthens Its Position as Provider of Critical and High Quality Biological Raw Materials to the IVD and Life Science Industries
By Business Wire India Published on June 23, 2025, 16:23 IST TOKYO, Japan & MALVERN, Pa., United States: H.U. Group Holdings Inc., and its wholly owned subsidiary, Fujirebio Holdings, Inc. (hereinafter 'Fujirebio') today announced that Fujirebio Diagnostics, Inc., a subsidiary of Fujirebio, has acquired all shares of Plasma Services Group, Inc. (hereinafter 'Plasma Services Group'). The transaction value has not been disclosed. Founded in 2004, Plasma Services Group has specialized in the collection, screening and supply of high quality and rare biological materials required for R&D and manufacturing in the in vitro diagnostics (IVD) and life science industries. The company is particularly well positioned in the field of rare diseases. From its state-of-the-art FDA registered, ISO certified facility in Moorestown, NJ, USA, Plasma Services Group provides sera and other samples for materials of control reagents and calibrators for a wide range of diseases and offers sample collection services globally. For more information about Plasma Services Group please visit 'We are excited to welcome Plasma Services Group, a company that has gained a solid reputation as a reliable global supplier of difficult-to-obtain biological raw materials to the life sciences industry, to the Fujirebio group of companies,' says Goki Ishikawa, President & CEO of Fujirebio Holdings, Inc. 'Current and future IVD and life science partners of Fujirebio and Plasma Services Group will benefit from the synergies in our combined offer of rare samples and biological materials, which in turn further reinforce Fujirebio's position in the market as a trusted CDMO partner.' 'For over 20 years our mission at PSG has always been rooted in serving our customers with care, integrity, and a commitment to quality,' said Nichelle Fernandez, President of Plasma Services Group. 'This next chapter with Fujirebio is deeply meaningful. It allows us to stay true to who we are while preserving the personal, responsive service our customers value. Together, we're positioned to offer even stronger support for the scientists and innovators who rely on us. Our shared commitment to consistency will have a lasting impact across the global IVD landscape.' Advisors Houlihan Lokey acted as exclusive financial advisor to Fujirebio. Achelous Partners acted as exclusive financial advisor to Plasma Services Group. About Fujirebio Fujirebio is global R&D-driven company constantly developing new IVD testing technologies and unique biomarkers with high clinical value. Our group mission is to create new value in healthcare and thereby contribute to human health and the future of medical global teams located in Japan, Asia, Europe, and the US focus on delivering products with the highest quality standards to our customers and partners. We value CDMO partnerships with many of the world's leading diagnostic companies, sharing knowledge, capabilities, and critical materials to supply, develop, or manufacture diagnostic solutions on a wide variety of more information about Fujirebio, please visit View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash Business Wire India, established in 2002, India's premier media distribution company ensures guaranteed media coverage through its network of 30+ cities and top news agencies.
National Post
23-06-2025
- Business
- National Post
Fujirebio Acquires Plasma Services Group and Strengthens Its Position as Provider of Critical and High Quality Biological Raw Materials to the IVD and Life Science Industries
Article content MALVERN, Pa. & TOKYO — H.U. Group Holdings Inc., and its wholly owned subsidiary, Fujirebio Holdings, Inc. (hereinafter 'Fujirebio') today announced that Fujirebio Diagnostics, Inc., a subsidiary of Fujirebio, has acquired all shares of Plasma Services Group, Inc. (hereinafter 'Plasma Services Group'). The transaction value has not been disclosed. Article content Founded in 2004, Plasma Services Group has specialized in the collection, screening and supply of high quality and rare biological materials required for R&D and manufacturing in the in vitro diagnostics (IVD) and life science industries. The company is particularly well positioned in the field of rare diseases. From its state-of-the-art FDA registered, ISO certified facility in Moorestown, NJ, USA, Plasma Services Group provides sera and other samples for materials of control reagents and calibrators for a wide range of diseases and offers sample collection services globally. For more information about Plasma Services Group please visit Article content 'We are excited to welcome Plasma Services Group, a company that has gained a solid reputation as a reliable global supplier of difficult-to-obtain biological raw materials to the life sciences industry, to the Fujirebio group of companies,' Article content says Goki Ishikawa, President & CEO of Fujirebio Holdings, Inc Article content . 'Current and future IVD and life science partners of Fujirebio and Plasma Services Group will benefit from the synergies in our combined offer of rare samples and biological materials, which in turn further reinforce Fujirebio's position in the market as a trusted CDMO partner.' Article content 'For over 20 years our mission at PSG has always been rooted in serving our customers with care, integrity, and a commitment to quality,' Article content said Nichelle Fernandez, President of Plasma Services Group Article content . 'This next chapter with Fujirebio is deeply meaningful. It allows us to stay true to who we are while preserving the personal, responsive service our customers value. Together, we're positioned to offer even stronger support for the scientists and innovators who rely on us. Our shared commitment to consistency will have a lasting impact across the global IVD landscape.' Article content Achelous Partners acted as exclusive financial advisor to Plasma Services Group. Article content About Fujirebio Article content Fujirebio is global R&D-driven company constantly developing new IVD testing technologies and unique biomarkers with high clinical value. Our group mission is to create new value in healthcare and thereby contribute to human health and the future of medical care. Article content Article content Our global teams located in Japan, Asia, Europe, and the US focus on delivering products with the highest quality standards to our customers and partners. We value CDMO partnerships with many of the world's leading diagnostic companies, sharing knowledge, capabilities, and critical materials to supply, develop, or manufacture diagnostic solutions on a wide variety of platforms. Article content Article content Article content Article content Article content Article content Contacts Article content
Business Wire
23-06-2025
- Business
- Business Wire
Fujirebio Acquires Plasma Services Group and Strengthens Its Position as Provider of Critical and High Quality Biological Raw Materials to the IVD and Life Science Industries
MALVERN, Pa. & TOKYO--(BUSINESS WIRE)--H.U. Group Holdings Inc., and its wholly owned subsidiary, Fujirebio Holdings, Inc. (hereinafter 'Fujirebio') today announced that Fujirebio Diagnostics, Inc., a subsidiary of Fujirebio, has acquired all shares of Plasma Services Group, Inc. (hereinafter 'Plasma Services Group'). The transaction value has not been disclosed. Current and future IVD and life science partners of Fujirebio and Plasma Services Group will benefit from the synergies in our combined offer of rare samples and biological materials. Founded in 2004, Plasma Services Group has specialized in the collection, screening and supply of high quality and rare biological materials required for R&D and manufacturing in the in vitro diagnostics (IVD) and life science industries. The company is particularly well positioned in the field of rare diseases. From its state-of-the-art FDA registered, ISO certified facility in Moorestown, NJ, USA, Plasma Services Group provides sera and other samples for materials of control reagents and calibrators for a wide range of diseases and offers sample collection services globally. For more information about Plasma Services Group please visit 'We are excited to welcome Plasma Services Group, a company that has gained a solid reputation as a reliable global supplier of difficult-to-obtain biological raw materials to the life sciences industry, to the Fujirebio group of companies,' says Goki Ishikawa, President & CEO of Fujirebio Holdings, Inc. 'Current and future IVD and life science partners of Fujirebio and Plasma Services Group will benefit from the synergies in our combined offer of rare samples and biological materials, which in turn further reinforce Fujirebio's position in the market as a trusted CDMO partner.' 'For over 20 years our mission at PSG has always been rooted in serving our customers with care, integrity, and a commitment to quality,' said Nichelle Fernandez, President of Plasma Services Group. 'This next chapter with Fujirebio is deeply meaningful. It allows us to stay true to who we are while preserving the personal, responsive service our customers value. Together, we're positioned to offer even stronger support for the scientists and innovators who rely on us. Our shared commitment to consistency will have a lasting impact across the global IVD landscape.' Advisors Houlihan Lokey acted as exclusive financial advisor to Fujirebio. Achelous Partners acted as exclusive financial advisor to Plasma Services Group. About Fujirebio Fujirebio is global R&D-driven company constantly developing new IVD testing technologies and unique biomarkers with high clinical value. Our group mission is to create new value in healthcare and thereby contribute to human health and the future of medical care. Our global teams located in Japan, Asia, Europe, and the US focus on delivering products with the highest quality standards to our customers and partners. We value CDMO partnerships with many of the world's leading diagnostic companies, sharing knowledge, capabilities, and critical materials to supply, develop, or manufacture diagnostic solutions on a wide variety of platforms. For more information about Fujirebio, please visit
