Latest news with #LumipulseG
Business Wire
6 days ago
- Business
- Business Wire
Fujirebio Expands Its Neuro Testing Portfolio With the Launch of the Fully Automated Lumipulse® G sTREM2 Assay for Research Use Only
GENT, Belgium & MALVERN, Pa. & TOKYO--(BUSINESS WIRE)--H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio today announced the availability of the Lumipulse G sTREM2 assay for the fully automated LUMIPULSE® G immunoassay analyzers. This CLEIA (chemiluminescent enzyme immunoassay) assay is available for Research Use Only (RUO) and allows for the quantitative measurement of soluble Triggering Receptor Expressed on Myeloid Cells 2 (sTREM2) in human cerebrospinal fluid (CSF) and blood within just 35 minutes. sTREM2 complements established biomarkers like GFAP, NfL, and pTau by adding essential insight into neuroinflammation - offering a more complete picture of the disease on a single platform. Share sTREM2 is a promising biomarker of microglial activation, offering researchers insights into neuroinflammation linked to Alzheimer's and other neurodegenerative diseases. sTREM2 can be valuable for capturing the dynamics of inflammatory responses or for monitoring inflammatory modulators. This test complements Fujirebio's growing portfolio of neuro biomarkers, including GFAP, NfL, and pTau, and reinforces the company's leading position in advancing neuro biomarker research tools and diagnostics. 'By adding sTREM2 to our neuro portfolio, we're enabling a more comprehensive view of neurological disease mechanisms,' said Goki Ishikawa, President and CEO of Fujirebio Holdings, Inc. 'sTREM2 complements established biomarkers like GFAP, NfL, and pTau by adding essential insight into neuroinflammation - offering a more complete picture of the disease on a single platform.' The new test allows researchers and clinical research professionals to further study and understand the potential clinical utility of this promising microglial biomarker. The availability of the assay on the fully automated random access LUMIPULSE G analyzers gives researchers access to convenient, accurate, and robust measurement of sTREM2. Already widely available for routine use in neurological disease testing worldwide, these analyzers meet all necessary quality, throughput, and regulatory requirements. About Fujirebio Fujirebio, a member of H.U. Group Holdings Inc., is a global leader in the field of high-quality RUO and 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 offers a comprehensive line-up of manual and fully automated assays for neurological diseases 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
Yahoo
19-05-2025
- Health
- Yahoo
FDA grants 510(k) clearance to Fujirebio's blood-based test for Alzheimer's
The US Food and Drug Administration (FDA) has awarded 510(k) clearance to Fujirebio's Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in vitro diagnostic (IVD) test for evaluating amyloid pathology in individuals under assessment for Alzheimer's disease and other cognitive decline causes. The test claims to be the first blood-based IVD test in the country cleared by the regulator to help detect those with amyloid pathology associated with the illness. According to the company, this test offers a minimally invasive and accessible pTau 217 and β-Amyloid 1-42 concentration measurement in plasma, serving as an indicator of β-Amyloid plaque pathology presence in the brain. Intended for use in adults aged ≥ 50 years presenting with cognitive decline symptoms, the test was evaluated in a clinical trial of 499 subjects, reflecting US demographics, and using a dual cut point. In the trial, it showed positive and negative predictive values of 92% and 97%, respectively, with 20% of subjects needing further testing for amyloid pathology. It operates using the company's fully automated LUMIPULSE G1200 instrument system. The new ratio test reportedly complements the previously FDA-authorised Lumipulse G β-Amyloid Ratio (1-42/1-40) for use in cerebrospinal fluid (CSF), in May 2022. The agency noted that the test measures the levels of two proteins, pTau217 and β-amyloid 1-42, in human plasma and calculates their ratio. This ratio correlates with the presence or absence of amyloid plaques in the patient's brain, potentially minimising the requirement of a positron emission tomography (PET) scan. Fujirebio Diagnostics CEO and president Monte Wiltse said: 'The Lumipulse G pTau 217/ β-Amyloid 1-42 Plasma Ratio test will go a long way to assist physicians and patients to obtain an Alzheimer's diagnosis in early stages of the disease, when interventions are more effective. 'As part of our worldwide commitment to improve 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.' Last July, Fujirebio introduced the Lumipulse G GFAP assay in the US, a neurological research tool tailored for measuring glial fibrillary acidic protein (GFAP). "FDA grants 510(k) clearance to Fujirebio's blood-based test for Alzheimer's" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 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
Business Wire
17-05-2025
- Health
- Business Wire
Fujirebio Receives Marketing Clearance for Lumipulse ® G pTau 217/ β-Amyloid 1-42 Plasma Ratio In-vitro Diagnostic Test as an Aid to Identify Patients With Amyloid Pathology Associated With Alzheimer's Disease
MALVERN, Pa., & TOKYO--(BUSINESS WIRE)--Fujirebio today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company's Lumipulse ® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test for the assessment of amyloid pathology in patients being evaluated for Alzheimer's disease and other causes of cognitive decline. The test, which was granted Breakthrough Device Designation by the FDA, is the first FDA cleared blood-based IVD test in the U.S. to aid to identify patients with amyloid pathology associated with Alzheimer's Disease (AD). Alzheimer's disease currently affects an estimated 7.2 million Americans, a number projected to rise to nearly 14 million by 2060. 1 It is a leading cause of disability and death. AD develops over many years, long before symptoms are evident, but the lack of accessible, minimally invasive diagnostics results in many patients remaining undiagnosed until the disease is well advanced, when few effective interventions remain. The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test is an accurate, minimally invasive, accessible measurement of pTau 217 and β-Amyloid 1-42 concentrations in plasma as a proxy for the presence of β-Amyloid plaque pathology in the brain. It is intended for use in adult patients aged 50 years and older presenting at a specialized care setting with signs and symptoms of cognitive decline. In a clinical study population of 499 patients, which closely mirrored the US demographics, and when applying a dual cut point, the test demonstrated a positive predicate value (PPV) of 92%, a negative predicate value (NPV) of 97% with only 20% patients who are uncertain to have amyloid pathology, thus requiring further testing. 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, accessible and minimally invasive diagnostics for AD contributes to its late diagnosis and inadequate treatment,' says Monte Wiltse, President and CEO at Fujirebio Diagnostics, Inc. 'The Lumipulse G pTau 217/ β-Amyloid 1-42 Plasma Ratio test will go a long way to assist physicians and patients to obtain an AD diagnosis in early stages of the disease, when interventions are more effective. As part of our worldwide commitment to improve 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 offers a comprehensive line-up of manual and fully automated assays for neurological diseases 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 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 Reference
Time of India
17-05-2025
- Health
- Time of India
Alzheimer's Disease: FDA greenlights first-of-its-kind blood test for Alzheimer's disease: How does it work?
The US Food and Drug Administration (FDA) has granted marketing clearance for a new blood test designed to assist in the diagnosis of Alzheimer's disease, marking it as the first test approved in the United States for the early detection of this condition. Tired of too many ads? go ad free now How does the blood test work? Named the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, this test is intended for adults aged 55 and older who exhibit signs and symptoms of Alzheimer's. The FDA announced this development on a Friday, highlighting the significance of the test that analyzes two specific proteins in blood plasma: pTau217 and beta-amyloid 1-42. The ratio of these proteins is known to correlate with the presence or absence of amyloid plaques in the brain, which are characteristic markers of Alzheimer's disease, although the test does not directly measure amyloid levels. Currently, there is no singular test for diagnosing Alzheimer's disease. Physicians typically utilize a comprehensive approach that includes an evaluation of medical history, neurological exams, cognitive and functional assessments, brain imaging, spinal fluid analysis, and, more recently, blood tests. The results from this newly approved blood test will need to be interpreted alongside other clinical information pertaining to the patient. FDA Commissioner Dr. Martin Makary emphasized the profound impact of Alzheimer's disease on the population, noting that it affects more individuals than breast and prostate cancer combined. He pointed out that approximately 10% of people aged 65 and older are living with Alzheimer's, a figure expected to double by 2050. Dr. Makary expressed optimism that innovative medical products, like this blood test, will significantly benefit patients. Tired of too many ads? go ad free now A new hope: Developed by Fujirebio Diagnostics Inc., a biotechnology company based in Pennsylvania, the new blood test aims to improve access to Alzheimer's detection and lessen the reliance on positron emission tomography (PET) scans. PET scans can reveal the presence of amyloid plaques in the brain, but they are often costly, sometimes amounting to thousands of dollars without insurance coverage. The FDA assessed clinical trial data involving plasma samples from 499 cognitively impaired adults. The study compared the blood test results with findings from PET scans or cerebrospinal fluid analysis, such as results from spinal taps. According to the FDA, the data demonstrated that 91.7% of the adults with positive blood test outcomes had confirmed amyloid plaques via their PET scans or cerebrospinal fluid tests, while 97.3% of those with negative blood test results also had negative outcomes in their PET scans or cerebrospinal fluid tests. The agency cautioned that the main risks associated with this blood test involve the potential for false-positive or false-negative results. The new era: A "new era" in Alzheimer's research is emerging, highlighted by recent advancements in diagnostic methods. Dr. Richard Isaacson, a preventive neurologist and pioneer in Alzheimer's prevention, has been utilizing an FDA-cleared blood test in his research for several years. This test helps determine whether individuals experiencing memory loss may be suffering from Alzheimer's disease. According to Isaacson, this blood test serves as a simpler and more cost-effective alternative to traditional diagnostic methods, such as PET scans or spinal taps. While the FDA's approval represents significant progress, Isaacson cautions that further research is essential to clarify how the results of this blood test should be interpreted and applied in clinical settings. He emphasizes the need for enhanced education surrounding the implications of the test results, noting that their meaning can vary based on individual risk factors and symptoms. Fujirebio Diagnostics developed this blood test to facilitate early detection of Alzheimer's disease, which is crucial for timely intervention. Monte Wiltse, the company's president and CEO, stated that accurate, early diagnosis could drive the creation of new drug therapies, especially given the increasing prevalence of Alzheimer's disease associated with global population aging. Statistics indicate that over 40% of individuals aged 55 and older in the United States are expected to develop dementia in their later years. Importantly, amyloid deposits may accumulate in the brain years before symptoms appear, suggesting that early detection could enable proactive measures to slow the disease's progression, including preventive treatments. Dr. Maria Carrillo, chief science officer at the Alzheimer's Association, expressed optimism that this recent will make accurate diagnoses more accessible. Although several lab-developed tests exist to identify blood-based biomarkers linked to Alzheimer's, the Fujirebio test is the first to gain FDA clearance, marking a milestone in the field. Carrillo noted that blood-based biomarkers are transforming our understanding and identification of Alzheimer's disease. However, there remain critical considerations for healthcare professionals regarding who should be tested and when. Dr. Howard Fillit, co-founder of the Alzheimer's Drug Discovery Foundation, remarked on the significance of being able to diagnose Alzheimer's more readily with a simple blood test—comparable to cholesterol testing. He believes this innovation illustrates a new era in Alzheimer's research, where advancements in science and technology are leading to more accessible and effective diagnostic tools. Scientists developing new diagnostic tool that can deliver health test results in two minutes
Yahoo
17-05-2025
- Health
- Yahoo
New blood test for Alzheimer's approved by FDA
May 16 (UPI) -- The U.S. Food and Drug Administration on Friday approved a new blood test for the early detection of Alzheimer's disease in patients beginning to show cognitive decline. Fujirebio Diagnostics, a firm dedicated to developing medical diagnostic products, has been cleared by the FDA to begin marketing the test, known as the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. "Nearly 7 million Americans are living with Alzheimer's disease and this number is projected to rise to nearly 13 million," said Dr. Michelle Tarver, the director of the Center for Devices and Radiological Health. "Today's clearance is an important step for Alzheimer's disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease." The test works by looking at the ratio of two proteins in a patient's blood plasma, which together are a sign of amyloid plaque buildup in the brain, which is a hallmark of Alzheimer's disease. Until now, confirming amyloid plaque has required costly PET brain scans or an invasive spinal tap to test cerebrospinal fluid. The new blood test would be cheaper and safer for patients testing for Alzheimer's disease. To clear the new blood test, the FDA evaluated data from a multi-center clinical study of 499 individual plasma samples from adults who were cognitively impaired and compared the results to those from tests using PET scans or spinal taps. In the study, when the blood test indicated a person likely had Alzheimer's-related plaques, it was correct about 92% of the time, the FDA determined. When the test said a person likely didn't have plaques, it was correct about 97% of the time. "These findings indicate that the new blood test can reliably predict the presence or absence of amyloid pathology associated with Alzheimer's disease at the time of the test in patients who are cognitively impaired," the FDA said in a news release. "The test is intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline. The results must be interpreted in conjunction with other patient clinical information."
