Latest news with #Fujirebio
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
Yahoo
06-06-2025
- Health
- Yahoo
New FDA-approved Alzheimer's blood test coming to Mayo Clinic
The Brief The FDA has approved the marketing of a new blood test by Fujirebio. The biomarker test measures the ratio of tau and amyloid proteins in the blood of a person with symptoms of cognitive decline to confirm the presence of Alzheimer's disease. Mayo Clinic will be one of 37 Alzheimer's clinics across the country to receive the new blood testing equipment starting at the end of June. MINNEAPOLIS (FOX 9) - The U.S. Food and Drug Administration has approved the marketing of a new tool to that can test a person's blood to diagnose Alzheimer's disease. The blood test is a groundbreaking development to confirm the disease in patients who are already experiencing cognitive decline. What we know The diagnostic tool, called Lumipulse, is manufactured by the world-wide medical research and development firm Fujirebio. The procedure, called the G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test, measures the presence of the amyloid and tau proteins in the brain that build the plaques leading to Alzheimer's disease. Fujirebio will now start distributing the diagnostic tests by the end of June to 37 Alzheimer's clinics across the United States including Mayo Clinic in Rochester, Minnesota. "I was very excited to get the news that there was an FDA approved test," said Alicia Algeciras-Schimnich, Ph.D. of Mayo Clinic who's been offering a version of the blood test for the past year in their laboratory. "It's just increasing the access to patients, and now many more laboratories will be able to offer this test." Dr. Algeciras-Schimnich says Mayo hopes will have the capacity to offer 1,000 to 5,000 blood tests a month with this new diagnostic protocol. What patients say Tim Sandry admits he's never had the best memory, but when he approached turning 67, he and his wife Ellen started noticing changes. "I wanted to find out what's going on here," recalled Sandry when he and his wife decided to see a neurologist. The doctor put him through a series of cognitive tests and determined he had what's called mild cognitive impairment which is a noticeable slowing of memory function. It wasn't long after his cognitive tests that a new diagnostic spinal tap was available to detect the presence of Alzheimer's disease. But it was invasive and painful. "In the morning they took the spinal fluid, and then I had to stay very still for the rest of the day. And then they sent me home, and I had an awful headache for the next three days," said Sandry of the hospital procedure. This new test would have saved him the pain and provided reliable results. "Oh, so much difference," said Sandry about the chance to have had a diagnostic blood test. "I mean, this blood test is going to shake things up dramatically I believe." Why you should care The faster a person experiencing cognitive decline can get a positive diagnosis for Alzheimer's the faster they can start taking one of two recently FDA approved drugs to slow the progression of the disease. Those drugs are Leqembi and Kisunla. "It makes it much quicker for those people to start treatment and to start looking at what options there are, whether it's clinical trials or medication," said Jenna Fink of the Alzheimer's Association Minnesota-North Dakota chapter. Sandry has been on a regimen of Leqembi since his own diagnosis and he believes it has dramatically slowed the disease in his own brain. "The sooner you get diagnosed, the quicker you can get on those drugs and the less damage this will do to your brain And the longer you will be able to function, cognitively," he said. Dig deeper The new blood test not only speeds up the diagnosis process, it also offers more accuracy. "The clinical diagnosis of Alzheimer disease is only about 70-75% accurate," said Mayo's Alicia Algeciras-Schimnich of the standard practice of cognitive testing and PET scans of the brain. Adding the blood biomarker test increases the accuracy of an Alzheimer's diagnosis to 90-95%. "So really, it is a significant improvement in the diagnosis for patients, which now can have an earlier answer for their symptoms," said Algeciras-Schmnich.' By the numbers As many as 101,900 Minnesotan over the age of 65 are living with Alzheimer's according to the 2025 facts and figures report from the Alzheimer's Association. That adds up to 10.7% of Minnesota adults over 65. Alzheimer's affects more than just the patients. For every patient, there are caregivers, many of them family members. When those numbers are added up, the Alzheimer's Association estimates there are 166,000 caregivers in Minnesota. Across the nation, 7.2 million Americans are living with the Alzheimer's, and 74% are over the age of 75.
