Latest news with #Lumipulse
Indian Express
3 days ago
- 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
4 days ago
- 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.
Medical News Today
6 days ago
- Health
- Medical News Today
FDA clears first blood test for Alzheimer's: How does it work?
The FDA has cleared the first blood test to diagnose Alzheimer's disease. Bowery Image Group Inc./Stocksy The earlier Alzheimer's disease can be diagnosed, the better the outcomes; however, it can be hard to diagnose the disease in its earliest stages. The United States Food and Drug Administration recently cleared the first blood test to help diagnose Alzheimer's disease. The new test measures the amount of proteins amyloid-beta and tau in the blood, and is less invasive than the currently used spinal tap to measure levels of these proteins in cerebrospinal fluid. Like all diseases, the sooner Alzheimer's disease is diagnosed, the better the outcome. This is partially because medications available for the condition aim to treat symptoms and potentially slow the progression of the disease. Despite all these tools, it can be hard to diagnose Alzheimer's disease, especially at its earliest stage . According to the FDA's press release , the Lumipulse blood test works by measuring the amount of pTau 217 and beta-amyloid 1-42 in the plasma of the blood. The concentration ratio of the two proteins is used to determine the presence or absence of amyloid plaques in the brain, which is considered a hallmark of Alzheimer's disease. 'Imagine your brain is like an organized library, with information neatly stored on shelves (neurons),' Manisha Parulekar, MD, FACP, AGSF, CMD, director of the Division of Geriatrics at Hackensack University Medical Center and co-director of the Center for Memory Loss and Brain Health at Hackensack University Medical Center in New Jersey explained to Medical News Today. 'In Alzheimer's disease, two troublesome proteins, beta-amyloid and tau, disrupt this organization, making it hard to access the information.' 'Think of beta-amyloid as sticky notes that clump together between the bookshelves (outside the neurons),' Parulekar continued. 'These clumps, called plaques, interfere with communication between the neurons, like blocking pathways in the library. Tau is normally like a librarian, helping to keep the bookshelves (internal neuron structure) stable and organized. In Alzheimer's, tau becomes twisted and tangled. These tangles disrupt the transport of nutrients and other essential materials within the neurons, eventually leading to their death,' she said. 'In simple terms, this blood test helps identify the 'culprits' responsible for Alzheimer's damage, allowing for earlier diagnosis, better disease management, and faster development of effective treatments.' — Manisha Parulekar, MD, FACP, AGSF, CMD Up until now, the main laboratory test to check levels of amyloid-beta and tau proteins was by examining a sample of a person's cerebrospinal fluid (CSF). The sample is taken through a lumbar puncture — also known as a spinal tap — where a needle is inserted into a person's lower spine. Gediminas Gliebus, MD, director of cognitive and behavioral neurology at Marcus Neuroscience Institute, a part of Baptist Health South Florida, told MNT having a test requiring a blood sample instead of a CSF sample significantly simplifies the testing process, eliminating the need for invasive and costly procedures like lumbar punctures, which can deter some patients from seeking evaluation. 'By relying on a simple blood sample, this test makes it more accessible to a broader population, facilitating earlier diagnosis and enabling timely interventions that could help manage the progression of the disease. This new test has the potential to change how we diagnose Alzheimer's disease by streamlining the process and reducing the need for more invasive procedures.' — Gediminas Gliebus, MD 'Based on the scientific data provided by the company, only 20% of patients would require additional invasive and costly tests, such as lumbar punctures or PET scans, to confirm the diagnosis. This is a significant improvement, as it allows the majority of patients to receive a preliminary evaluation with minimal discomfort and expense, fostering early detection and intervention,' Gliebus explained. As part of their approval announcement, the FDA stated risks associated with the Lumipulse blood test include both false positive and negative results. For that reason, all of the experts we spoke with agree that while this new test is a promising diagnostic tool, it is not the only tool that should be used and more research is still needed. 'This test has potential for use in pre-screening participants in clinical trials for early stages of Alzheimer's disease, however, its application in primary care settings is not yet fully understood, and further research is needed before it is used as a screening tool for the general population,' Bhavana Patel, DO, assistant professor of neurology at the University of Florida explained to MNT . Things to keep in mind about the test 'As with many tests, false positives and false negatives can occur. Therefore, this test should be done in the setting of cognitive symptoms and with a specialist who can accurately interpret and counsel on the results.' — Bhavana Patel, DO, 'My first response to this blood test is concern (that) primary care physicians are going to diagnose patients with Alzheimer's dementia from a blood test who have no memory loss or risk factors for dementia,' added Clifford Segil, DO a neurologist in private practice in Santa Monica, CA, and on staff at Providence St John's Health Center. 'And tests like this, which were not approved by the typical rigorous FDA pathway, but rather through an abbreviated process via the FDA's ' Breakthrough Pathway ,' which cause me concern countless people are going to be told they have dementia per a blood test when they do not have dementia,' he said. 'Neurologists in clinical practice have found similar tau and amyloid biomarkers to have a high percentage of false positives in clinical practice and do not rely only on a blood test to diagnose a family member or you with dementia,' Segil told MNT . 'Neurologists are unlikely to use these tests, which will be used by primary care physicians. If you do get a positive result from a blood tau or amyloid test, please be evaluated by a neurologist to determine if they have any clinical significance.' With some questions still to be answered regarding the Lumipulse blood test, many experts expressed their hope that it will provide more assistance in the early diagnosis of Alzheimer's disease. 'This is an exciting time in the field, as we now have a noninvasive, easily accessible test that can help identify Alzheimer's disease in individuals experiencing memory changes,' Patel said. 'Having an easily accessible blood test will allow for an earlier diagnosis in those with cognitive changes and serve as an opportunity for participation in clinical trials and receive treatments that may impact disease progression.' 'I was genuinely excited to hear about the FDA's [clearing] of this blood test, as it represents a significant advancement in simplifying the evaluation of patients who present with symptoms that might suggest Alzheimer's disease,' Gliebus commented. 'This test offers a less invasive and more accessible way to evaluate the condition, potentially transforming how we approach early diagnosis and patient care.' Lower cost, less invasive 'The less invasive nature of a blood test will likely encourage more people experiencing mild cognitive impairment or early symptoms to seek testing. Earlier diagnosis is crucial for maximizing the effectiveness of current and future treatments. The simplicity and lower cost of blood tests compared to PET scans or spinal taps will make testing more accessible to wider populations, including those in underserved communities or without easy access to specialized medical centers. This could lead to earlier diagnosis for individuals who might otherwise go undiagnosed for years.' — Manisha Parulekar, MD, FACP, AGSF, CMD 'We do have to follow appropriate steps in the diagnosis and make sure to use this as a diagnostic tool — this is not a screening test. It's a tool that holds promise — its true impact will depend on how it's integrated into clinical practice,' Parulekar added.
Yahoo
21-05-2025
- Health
- Yahoo
FDA Clears First Blood Test to Diagnose Alzheimer's Disease
The FDA greenlit marketing for the first blood test to help diagnose Alzheimer's disease The test measures two proteins, beta-amyloid and p-tau217, which are hallmarks of the disease Experts believe this will increase access to Alzheimer's detection and reduce reliance on expensive PET scans and invasive spinal tapsThe Food and Drug Administration has given marketing clearance to the first blood test to help diagnose Alzheimer's disease. On May 16, the agency announced clearance of the test — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio — manufactured by the Pennsylvania-based biotechnology company Fujirebio Diagnostics. The test works by measuring proteins beta-amyloid and p-tau217, which are believed to be hallmarks of Alzheimer's disease. Alzheimer's is a degenerative brain disease that is caused by complex brain changes following cell damage. It progressively affects memory, thinking and behavior seriously enough to interfere with daily tasks. The blood test was cleared for use in people age 55 and older who exhibit signs and symptoms of the disease. The FDA said this new test can help increase access to Alzheimer's disease detection and reduce reliance on PET scans or spinal taps, which are more expensive and invasive. ! Never miss a story — sign up for to stay up-to-date on the best of what PEOPLE has to offer, from celebrity news to compelling human interest stories. 'Nearly 7 million Americans are living with Alzheimer's disease and this number is projected to rise to nearly 13 million,' Dr. Michelle Tarver, director of the Center for Devices and Radiological Health, said in a statement. '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 FDA said that it conducted a study that evaluated 499 plasma samples from patients who were cognitively impaired and compared the results of the blood test with the results by PET scan or spinal tap. Researchers found that the blood test was nearly 92% as accurate as a PET scan or spinal tap in detecting patients with Alzheimer's and over 97% as accurate in identifying patients who did not have the disease. Dr. Richard Isaacson, a preventative neurologist who established one of the first Alzheimer's prevention clinics in the United States, told CNN that he has been using this blood test for years for research and applauded the FDA clearance. 'It can provide better clarity into whether a person experiencing memory loss may have Alzheimer's disease. They can take this test as a screening test,' he said. 'This is a much more simple screening test, with reasonable accuracy, to tell the physician that a person with cognitive decline has symptoms that are actually due to Alzheimer's disease.' While the clearance is a step forward, Isaacson stressed that more research is necessary to determine how the blood test results should be interpreted and used to make medical decisions. Read the original article on People
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Business Standard
21-05-2025
- Health
- Business Standard
Alzheimer's diagnosis with blood test becomes reality: All you need to know
Lumipulse G pTau217/ß-Amyloid 1-42: USFDA has approved the first-ever blood test to help diagnose Alzheimer's disease, offering a faster, less invasive, and more affordable way to detect early signs Barkha Mathur New Delhi The US Food and Drug Administration (FDA) has approved the first-ever in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer's disease. Set to launch in June 2025, the test offers a faster, more accessible, and less invasive alternative to PET scans and spinal taps, especially for people showing early signs of memory loss and cognitive decline. It has been granted 'Breakthrough Device' designation by the FDA, reflecting its potential to significantly improve Alzheimer's detection and care. 'Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined,' said FDA Commissioner Martin A Makary in a statement. 'Knowing that 10 per cent of people aged 65 and older have Alzheimer's, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.' What is the Lumipulse blood test and how does it work? Developed by Fujirebio Diagnostics, the test is called the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. It measures the ratio of two key biomarkers in the blood—β-amyloid 1-42 and β-amyloid 1-40—both of which are linked to the buildup of amyloid plaques in the brain, a defining feature of Alzheimer's disease. Who can take Alzheimer's blood test and when should it be used? The test is intended for adults aged 55 and older who are showing early signs of cognitive decline, such as memory loss or confusion. It is not a screening tool for asymptomatic individuals and is not available over the counter. The FDA emphasised that the test should support, not replace, a doctor's clinical assessment. It requires a physician's referral and is not meant for standalone diagnosis. What are the current ways Alzheimer's is diagnosed? Traditional diagnostic methods include: Cognitive tests and memory assessments Brain scans such as MRI or PET Spinal taps for cerebrospinal fluid (CSF) analysis These tests can be costly, invasive, and are not always covered by insurance—especially in developing countries. How accurate is the Alzheimer's blood test compared to current diagnostic methods? In a clinical trial involving 499 patients, the test demonstrated high diagnostic reliability: 91.7 per cent of people with positive results had Alzheimer's-associated plaques confirmed by PET scans or spinal taps 97.3 per cent of those with negative results had no plaques This level of accuracy could significantly reduce the need for expensive and invasive PET imaging or lumbar punctures. When and where will the Alzheimer's test be available? Fujirebio has confirmed that the test will be available in certified laboratories across the United States starting June 2025. It will not be sold directly to consumers and will require a physician's order. How can this test impact Alzheimer's treatment? Early diagnosis allows earlier intervention, which is critical to slowing the progression of Alzheimer's disease. This test could help doctors identify candidates for drugs like Leqembi (lecanemab) and Kisunla (donanemab) before significant brain damage occurs. A positive test result indicates the presence of amyloid plaques but does not confirm Alzheimer's on its own. False positives and negatives are possible, and results must be interpreted alongside other clinical evaluations. Why this matters for Alzheirmer's patients and caregivers This new blood test marks a significant breakthrough in making Alzheimer's diagnosis more accessible and less burdensome. For families and patients, it could mean earlier answers, targeted treatments, and improved planning for the future. For more health updates, follow #HealthWithBS
