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Yahoo
28-07-2025
- Health
- Yahoo
Cutting-edge Diagnostic Technologies Transforming $6.4 Billion Landscape
The U.S. Alzheimer's disease diagnostics market, valued at USD 3.53 billion in 2024, is projected to grow at a CAGR of 10.6% from 2025-2030. Growth is driven by rising Alzheimer's prevalence and advanced diagnostics like FDA-approved blood tests, improving early detection and care planning. U.S. Alzheimer's Disease Diagnostics Market Dublin, July 28, 2025 (GLOBE NEWSWIRE) -- The "U.S. Alzheimer's Disease Diagnostics Market Size, Share & Trends Analysis Report By Diagnostic Technique (Biomarkers, Imaging Techniques, Genetic Testing, Cognitive Assessment Tests), By Type, By End-use, And Segment Forecasts, 2025 - 2030" report has been added to U.S. Alzheimer's disease diagnostics market was valued at USD 3.53 billion in 2024 and is expected to grow at a CAGR of 10.6% from 2025 to 2030 This growth is driven by the rising prevalence of Alzheimer's disease and increasing emphasis on early and accurate diagnosis. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 6.7 million older adults in the U.S. were living with Alzheimer's disease in 2024, a number projected to nearly double by 2060. The growing prevalence of the disease prompted government and private healthcare bodies to invest heavily in advanced diagnostic technologies such as PET imaging, cerebrospinal fluid biomarkers, and blood-based diagnostics. The growth of the U.S. Alzheimer's disease diagnostics market is due to the recent regulatory approval of advanced, non-invasive diagnostic technologies. The U.S. FDA granted marketing clearance for the first in vitro diagnostic device that utilizes a blood test to support the diagnosis of Alzheimer's disease. The Lumipulse G pTau217/b-Amyloid 1-42 Plasma Ratio is specifically intended for the early detection of amyloid plaque accumulation, a hallmark of Alzheimer's pathology, in adult patients aged 55 years and older who are exhibiting clinical signs and symptoms consistent with cognitive development represents a major advancement in Alzheimer's diagnostics, significantly lowering access barriers by providing a cost-effective and minimally invasive alternative to PET scans and lumbar punctures, which often carry procedural risks. The FDA highlighted that this approval makes it easier and potentially more accessible for U.S. patients earlier in the disease. It underscores the test's value in facilitating timely intervention and clinical decision-making in the early stages of Alzheimer's disease increasing rate of dementia diagnosis among older adults is driving the growth of the U.S. Alzheimer's diagnostics market. According to the 2022 National Health Interview Survey by the CDC, approximately 4% of individuals aged 65 and older have been diagnosed with dementia, with this figure rising to 13% among those aged 85 and above. This growth is primarily attributed to longer life expectancy, enhanced awareness, and improved diagnostic practices across clinical settings. The rising need for scalable, accurate diagnostic solutions to support early detection, appropriate intervention, and optimized care planning. Why should you buy this report? Comprehensive Market Analysis: Gain detailed insights into the global market across major regions and segments. Competitive Landscape: Explore the market presence of key players worldwide. Future Trends: Discover the pivotal trends and drivers shaping the future of the global market. Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions. Key Attributes: Report Attribute Details No. of Pages 80 Forecast Period 2024 - 2030 Estimated Market Value (USD) in 2024 $3.53 Billion Forecasted Market Value (USD) by 2030 $6.43 Billion Compound Annual Growth Rate 10.6% Regions Covered United States Competitive Landscape GE HealthCare Siemens Healthineers AG Canon Medical Systems Corporation Cerveau Technologies, Inc. Neurovision Imaging, Inc. Thermo Fisher Scientific Inc. Bio-Rad Laboratories, Inc. Quanterix Corporation Alzheon Inc. NanoSomiX, Inc. DiamiR Biosciences Company Overview Financial Performance Diagnostic Technique Portfolio Recent Developments/ Strategic Initiatives U.S. Alzheimer's Disease Diagnostics Market Report SegmentationDiagnostic Technique Outlook (Revenue, USD Million, 2018 - 2030) Biomarkers CSF Biomarkers Blood-Based Biomarkers Imaging Diagnostic Techniques Genetic Testing Cognitive Assessment Tests Type Outlook (Revenue, USD Million, 2018 - 2030) Triage Diagnosis Screening End Use Outlook (Revenue, USD Million, 2018 - 2030) Hospitals Diagnostic Laboratories Academic & Research Institutes For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment U.S. Alzheimer's Disease Diagnostics Market CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Sign in to access your portfolio
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.
Forbes
02-06-2025
- Business
- Forbes
Why Blood Test For Early Detection Of Alzheimer's Disease Matters
Test tube with blood sample for Alzheimer's disease test. Set to launch this month, a recently approved blood test to detect biomarkers for Alzheimer's disease could bring diagnosis into everyday clinical practice. In turn, this may support earlier intervention approaches that may help patients, their families and caregivers. The diagnostic, called a Lumipulse G Plasma Ratio test, is the first of its kind to get marketing clearance from the Food and Drug Administration. Until now, diagnosing Alzheimer's has often relied on costly and invasive tools like a PET scan or lumbar puncture. The blood test could reduce the need for intrusive diagnostics. Recently approved disease-modifying therapeutics that can modestly reduce the rate of cognitive decline may amplify the importance of having a convenient test. Alzheimer's disease affects approximately seven million Americans. By 2050, that number is expected to double. The condition robs people's memory with symptoms that progressively worsen over time. These include disorientation, changes in mood and behavior, confusion about time and place and eventually difficulty speaking, swallowing and walking. The newly authorized test achieved roughly 92% accuracy in clinical trials in identifying people who had build-up of two proteins—amyloid and tau—associated with Alzheimer's disease. The ratio of these substances helps determine the presence of amyloid plaques in the brain. The diagnostic is approved for people ages 55 and up who are already showing signs of cognitive decline. For patients, this could represent an important step in identifying possible causes, but also help navigate next steps, including potential use of treatment options. The FDA approved drugs Leqembi (lecanemab) and Kisunla (donenamab) in 2023 and 2024, respectively, for patients suffering from early-stage Alzheimer's disease. These therapeutics can slow disease progression, albeit modestly. They work by removing a sticky protein, beta amyloid plaque, from the brain. Tau 'tangles' are also thought to contribute to Alzheimer's. And in a phase 3 trial, Kisunla was shown to be effective at clearing both beta amyloid and tau. While treatments can lessen the speed at which cognitive and functional decline, persistent safety worries have plagued the medicines, too. These were highlighted, for instance, when the FDA initially denied approval of Kisunla. The agency questioned the drug's long-term safety, noting a relatively higher rate of treatment discontinuation due to adverse events such as amyloid-related imaging abnormalities that can lead to brain hemorrhage and swelling. Similar potentially dangerous side effects have also occurred in patients taking Leqembi. The cost of the Lumipulse test hasn't been publicly disclosed. Nor is there information regarding whether it will be covered by medical insurance. Presumably it will be considerably less costly per unit than, say, a brain scan. The cost of a dose of Amyvid (florbetapir F 18) used in PET scans to detect amyloid plaque accumulation, for example, is around $1,600 per dose. And the total cost, including use of a PET scanner and overhead, can be several thousand more. Medicare is obligated to cover a limited number of imaging tests for certain patients. When deciding upon coverage parameters for the new blood diagnostic, insurers such as Medicare will likely take into account not only the cost per unit but also the fact that a potentially much greater number of people may take the test. The blood test isn't without potential issues. To illustrate, a positive test doesn't prove someone has Alzheimer's. And so, the risk of false positives exists. Moreover, as with other tests, the results could trigger anxiety and stigma. Perhaps more importantly, Alzheimer's is more complex than the mere existence of amyloid plaque in a person's brain. While this may be a necessary condition of the disease, it is not a sufficient one. Genetics and other issues such as metabolic disease or even a virus may also play roles.
Indian Express
26-05-2025
- Health
- Indian Express
Blood test for Alzheimer's: What US FDA approval means for early diagnosis
The US Food and Drug Administration (FDA) has approved the first blood test for diagnosing Alzheimer's disease, a progressive neurodegenerative disorder that affects brain function and memory. The test, called Lumipulse, was granted breakthrough device approval and is designed for early detection of amyloid plaques associated with Alzheimer's disease in patients aged over 55 who exhibit signs and symptoms. Made by Fujirebio Diagnostics, the test measures the ratio between two proteins (pTau17 and beta-amyloid 1-42) in human plasma. The ratio is related to the presence of amyloid plaques in the brain that are linked to Alzheimer's. This test is significant to the extent that amyloid begins to accumulate and form plaques in the brain more than 20 years before any symptoms of cognitive impairment. Tau accumulates later, forming tangles in the brain, and is associated with impairment of brain functions. In that sense this is an early warning system, it allows for much earlier detection of the disease — even before clear memory or behavioural symptoms appear. However, the test is just indicative, not confirmatory. It has an efficacy of 60 to 70 per cent. The study found that the blood test was nearly 92 per cent as accurate as a PET scan or a spinal tap. Therefore, it should not be used on its own to diagnose or to rule out Alzheimer's. Other clinical evaluations, like imaging or additional tests, should be used for determining treatment options. The FDA itself has said that results must be interpreted in conjunction with other patient clinical information. Early diagnosis gives patients and families more time to understand the condition, plan care and consider available treatments or clinical trials. It can also help rule out Alzheimer's when symptoms are caused by other, potentially treatable conditions. Moreover, making this test widely available in primary care settings can help close the gap in diagnosis for people in underserved or remote areas. Overall, this development could make Alzheimer's diagnosis more timely, accurate and accessible for millions of people worldwide The test helps in how we diagnose and manage this condition. Until now, confirming a diagnosis of Alzheimer's typically required specialised procedures like PET brain scans or a lumbar puncture to test spinal fluid. These methods, while effective, are invasive, expensive and often not available in smaller hospitals or rural areas. By detecting biomarkers through a simple blood sample, doctors can now evaluate patients in a faster, less invasive and more affordable way.
Forbes
25-05-2025
- Health
- Forbes
Breakthrough Alzheimer's Blood Test Explained By Neurologists
Whether you're noticing changes in your memory that are affecting your daily life, caring for a loved one recently diagnosed with dementia, evaluating a patient as a physician, or simply worried about someone close to you, the recent FDA clearance of the Lumipulse blood test for the early diagnosis of Alzheimer's disease is a significant development that you should be aware of. Here's what you need to know about this Breakthrough Alzheimer's blood test. The Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test is designed for the early detection of amyloid plaques associated with Alzheimer's disease in adults aged 55 years and older who are showing signs and symptoms of the condition. If you've witnessed a loved one gradually lose their memories due to the impact of amyloid plaques in their brain, you understand how important a test like this can be. The Lumipulse test measures the levels of two proteins—pTau 217 and β-Amyloid 1-42—in plasma and calculates the ratio between them. This ratio is correlated with the presence or absence of amyloid plaques in the brain, potentially reducing the need for more invasive procedures like PET scans or spinal fluid analysis. Dr. Phillipe Douyon, a neurologist and author of '7 Things You Should Be Doing to Minimize Your Risk of Dementia,' notes that the Alzheimer's Association has reported that 50-70% of symptomatic patients in community settings are inaccurately diagnosed with Alzheimer's disease. In specialized memory clinics, this misdiagnosis rate drops to 25-30%. 'Having a test that provides early and accurate insights into the cause of someone's dementia could be a massive game changer,' says Dr. Douyon. This new test follows the recent FDA approval of two medications, lecanemab and donanemab, which are highly effective in removing amyloid from the brain. Clinical trials have shown that these treatments can slow the progression of dementia. Currently, to qualify for these medications, patients must undergo expensive examinations, such as a brain amyloid PET scan or a lumbar puncture to analyze their spinal fluid. Many patients, however, do not have access to PET imaging or specialist care. 'A blood test makes diagnostic procedures more accessible and benefits underserved populations,' says Dr. Haythum Tayeb, a neurologist at WMCHealth. 'It also enables earlier and more personalized care planning, even before formal treatment begins. This empowers patients and their families to make informed decisions sooner,' Dr. Tayeb adds. While this blood test may improve access to care for patients from communities lacking neurology and other specialty services, it is recommended to use it only for individuals experiencing memory problems, rather than for those who are asymptomatic. 'Given that there is no specific treatment indicated for asymptomatic persons, there is a risk of introducing psychological harm at this stage,' warns Dr. James Noble who is Professor of Neurology at Columbia University Irving Medical Center and author of Navigating Life With Dementia. 'Healthy approaches to lifestyle will remain central in adulthood whether or not someone has a positive test, and that advice will not really change,' adds Dr. Noble. Living a healthy lifestyle can significantly enhance brain health, regardless of whether a person has an abnormal accumulation of amyloid in their brain. Key factors include regular exercise, following a healthy diet such as the Mediterranean diet, getting adequate sleep, engaging in social and cognitive activities. These practices are all essential for maintaining cognitive function. Additionally, taking steps to protect your hearing may help reduce the risk of developing dementia. Anyone experiencing memory loss should consult their medical provider for an evaluation. The provider can conduct basic cognitive testing and determine if a referral to a specialist is necessary. If the individual meets the criteria for testing, the lumipulse blood test should also be considered. 'Looking across the wide landscape of medicine, many other conditions benefit from early detection, diagnosis, and treatment. There is no reason to believe that Alzheimer's disease will be any different' says Dr. Noble. Indeed, screening for diseases like colon cancer, breast cancer, and high blood pressure has significantly extended the average American lifespan. Imagine how much our lives could change if we could screen for Alzheimer's dementia in the same way. This would be particularly useful for patients at higher risk due to age or family history. Providing earlier intervention for Alzheimer's disease could potentially reduce amyloid buildup in the brain, help preserve memories, and allow individuals to live more independently at home, rather than in nursing homes. Another advantage of using a blood test like the Lumipulse blood test is the ability to inform a patient that their memory loss is unlikely to be due to Alzheimer's disease. While a negative blood test does not entirely rule out an Alzheimer's diagnosis, it does make it less probable. This could prompt the medical provider to conduct further testing to identify a more accurate cause for the patient's memory loss. It is reasonable to anticipate that additional blood-based biomarkers for diagnosing Alzheimer's disease and other dementias will be available in the future. Perhaps one day, there will be a dementia panel blood test that can be sent off to provide early diagnosis of a wide range of dementias. Alzheimer's blood testing is not only beneficial for individuals, but it also represents a significant advancement for research. Doctors and scientists can more easily identify individuals in the early stages of Alzheimer's disease, which accelerates clinical trials for new medications. This increased diagnostic accuracy can enhance the effectiveness of Alzheimer's clinical trials, as it ensures that patients enrolled have more reliable diagnoses. Consequently, new and more effective treatments could be developed and made available more quickly. The Lumipulse Alzheimer's blood test marks a pivotal moment in our approach to this disease. While patients may still need confirmatory testing through brain imaging or spinal fluid analysis, this blood test enables the medical community to adopt a more proactive, precise, and personalized strategy for diagnosing and treating patients with dementia. This simple blood test brings us one step closer to earlier answers, better care, and renewed hope for millions of people facing the uncertainty of dementia.
