Latest news with #FujirebioDiagnostics
Indian Express
5 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.
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
Newsweek
21-05-2025
- Health
- Newsweek
'Important' Alzheimer's Treatment Breakthrough Gets FDA Approval
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. The U.S. Food and Drug Administration (FDA) approved the first blood test to detect Alzheimer's disease in what federal officials called an "important step" toward diagnosing and treating the disease earlier. Developed by Fujirebio Diagnostics, the test analyzes the ratio of two proteins in a patient's blood, a measurement that correlates with the presence of amyloid plaques in the brain. These plaques are a hallmark of Alzheimer's and previously required either costly positron emission tomography (PET) scans, or invasive spinal fluid analysis for confirmation. The newly approved test can be used in clinics for patients showing signs of cognitive decline. The results are intended to be interpreted alongside other clinical assessments. Stock image: Jigsaw puzzle representing brain and mental health. Stock image: Jigsaw puzzle representing brain and mental health. Photo by designer491 / Getty Images Why It Matters The approval could accelerate the diagnosis process for a disease that impacts more than 6 million Americans and is expected to affect twice as many by 2050. Early diagnosis is crucial for patients to begin treatment with existing therapies that, while not curative, have been shown to slow cognitive decline. "Alzheimer's disease impacts too many people—more than breast cancer and prostate cancer combined," said FDA Commissioner Marty Makary, in the agency's press release. Diana Dickson, vice president of clinical and regulatory sciences at Fujirebio Diagnostics, noted the "millions" of people impacted by Alzheimer's, in addition to patients. "Millions of patients, family members and caregivers are impacted by this terrible disease and, unfortunately, low-invasive, accessible and affordable diagnostic tools have not been readily available," Dickson told Newsweek in an email. "With this FDA clearance, this test becomes available to physicians through any CLIA [Clinical Laboratory Improvement Amendments] laboratory, which enables access to plasma testing." What To Know The test is meant for use in people already showing signs of cognitive impairment. It should be used as part of a broader diagnostic work-up that includes clinical evaluation and possibly additional imaging. The approval comes as two Alzheimer's drugs—lecanemab and donanemab—are already authorized by the FDA. Both are antibody therapies that target amyloid plaques and are believed to be more effective when administered earlier in the disease's progression. Clinical studies found that the blood test's accuracy was comparable to PET imaging and spinal fluid testing. What People Are Saying Michelle Tarver, of the FDA's Center for Devices and Radiological Health, said: "Today's clearance is an important step for Alzheimer's diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease." Makary said: "Knowing that 10% 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." Dickson said the test is the culmination of more than 30 years of commitment by Fujirebio in the fight against Alzheimer's. "The battle is not nearly over," she continued, "There is much work to be done, not only with this test, but in the development of other novel biomarkers for use in other pathologies and in other neurodegenerative disease. "We continue to be committed to these efforts and are immensely grateful for the partnerships with the pharmaceutical, research and patient communities that have made and continue to make these advances possible." What Happens Next The blood test is now authorized for use in clinical practice, but adoption will depend on further integration into care pathways, insurance coverage decisions and physician familiarity. Dickson said Fujirebio is working to create packaging and inserts to send out their first shipments. The Pennsylvania-headquartered company is finding partners to make sure the clinical data drawn from the tests can be published and discussed within the clinical community. "Finally, we are engaged with various patient advocacy groups and medical specialties to ensure that the public is aware of the test, how it should and should not be used and how results are best interpreted," Dickson said.
The Hindu
20-05-2025
- Health
- The Hindu
Health Matters newsletter: Baby steps in personalised gene editing
On little Muldoon and potential cures for rare illnesses, climate change and India's escalating heat crisis, hypertension and how better nutrition may help, and more The biggest health story this past week, globally, was about little KJ Muldoon and what doctors could do for him. Muldoon, as the world knows him, is a U.S. infant with a rare condition who has become history's first patient to be treated with a personalised gene-editing technique. Besides raising hopes of cure or treatment for other people with obscure illnesses, the exact process of rehabilitating the nine-and-a-half-month-old KJ itself was simply fascinating. Being witness to medical history can be an upper in itself for some. Shortly after birth, he was diagnosed with a rare and serious condition called CPS1 deficiency, caused by a mutation in a gene that produces an enzyme key to liver function, and prevents people with it from eliminating certain kinds of toxic waste. With the prognosis grim, either death or a liver transplant, doctors suggested something that had never been done before: a personalised treatment to fix the baby's genome using what amounts to a pair of molecular scissors -- the technique called Crispr-Cas9, which earned its creators the Nobel prize for chemistry in 2020. The parents were in a dilemma, naturally, wondering if they should go conventional, or try this never before technique, but in the end, they agreed to have their baby go through this. Muldoon received an infusion created just for him to fix his genetic mutation -- incorrect DNA letters in the several billion that make up the human genome. 'The drug is really designed only for KJ, so the genetic variants that he has are specific to him. It's personalised medicine,' said Rebecca Ahrens-Nicklas, a member of the medical team who specialises in paediatric genetics. The team also wrote up the procedure in the mid May edition of The New England Journal of Medicine. Once the tailor-made infusion reaches the liver, the molecular scissors contained in it penetrates cells and goes to work editing the boy's flawed gene. The authors argued that the results were promising for other people with genetic conditions. KJ can now follow a diet richer in proteins -- his condition prohibited such before -- and does not need as much medicine as he used to. But he will need to follow-up long term to monitor the safety and efficacy of the treatment, the team said. Dr. Ahrens-Nicklas said she hoped this achievement will allow the boy to get by with little or no medication some day. 'We hope he is the first of many to benefit from a methodology that can be scaled to fit an individual patient's needs,' she said. The story of KJ will be interesting to follow, for sure. As we are already at achievements, let's proceed in the same celebratory vein. US approved the first blood test for Alzheimer's this past week. The test, developed by Fujirebio Diagnostics, measures the ratio of two proteins in the blood. The ratio is correlated with amyloid plaques in the brain -- a hallmark of Alzheimer's that, until now, has been detected only through brain scans or spinal fluid analysis. Neurologists say they can offer patients a few additional months of independence -- and are likely to be more effective if started earlier in the disease's course. There are currently two FDA approved treatments for Alzheimer's: lecanemab and donanemab, which target amyloid plaque and have been shown to modestly slow cognitive decline, though they do not cure the disease. Also recording here, our story on the FDA's approval for Novavax COVID vaccine with new conditions. The license restricts the use of the vaccine called Nuvaxovid to individuals aged 65 and older, and those between 12 and 64 who have at least one underlying condition that increases their risk of developing severe illness from COVID. The letter did not specify what qualified as an underlying condition. B. Madhu Gopal wrote on an indigenous Low-cost test on anvil to detect life-threatening pregnancy complication of preeclampsia. More details in the link. In other news we cannot ignore, we look at several aspects of climate change, heat and the impact on the human body. Dr. Poornima Prabhakaran makes a very impassioned plea for preparing our cities and vulnerable to deal with India's escalating heat crisis. Places once known for their temperate climates, like Bengaluru and Shimla, are now registering record-breaking temperatures. This shift is more than just a summer inconvenience; it's a public health emergency in slow motion. While most of us experience heat as discomfort, for those living with non-communicable diseases (NCDs) — such as diabetes, cardiovascular diseases, or respiratory illnesses — the consequences can be fatal. Hit the link for some tips, and some examples that your States can all be inspired by. Zhebin Yu and Erik Melen in The Conversation talk about how new research reveals that Urban environments significantly increase risk of developing asthma. In context, scientists are increasingly exploring mechanisms that can help the body adapt to rising temperatures affecting our sleep and leading to health complications. In another piece in The Conversation, Arun Durvasula explains How your genes interacting with your environment impacts on disease risk. Studying gene-environment interactions can tell researchers not only about which genetic and environmental factors increase your risk of disease, but also what goes wrong in the body, and where. This story talks about how Climate change increases risk of pregnancy problems. A recent study looked at 247 countries and territories and in 222 of them 'climate change at least doubled the average annual number of pregnancy heat-risk days experienced during the past five years'. In yet another article that linked climate changed to women's health, Geetha Srimathi looks at How extreme heat and poor sanitation endanger the health of women in outdoor jobs. Liffy Thomas's interesting piece: Heat and medication: A bitter pill looks at how we need to be careful with our regular medication too, during summer. Afshan Yasmeen relies on a study to talk about how a Diet rich in fruits and vegetable actually lowers the risk of acute respiratory infection & anaemia linked to air pollution in children. It's always good to know there are some factors we can control about our own health, even if so many factors are beyond our reach or even comprehension, sometimes. On the subject of nutrition, we had a bunch of stories this week, explaining various aspects of how good nutrition actually determines quality of life and keeps various non communicable diseases at arm's length. Dr. Anuja Agarwala, in this riveting piece, talks about reimagining school nutrition to tackle childhood hypertension. While offering the school noon meal programmes as a means of arresting some of the NCD issues, she also says that as these programmes scale up, they have an opportunity to evolve above basic nutrition. Divya Bharti in The ingredient to turn around nutrition outcomes, argues that in India's long battle against malnutrition, women and girls remain the most overlooked section. Despite steady economic progress and numerous welfare schemes, nutritional inequality continues to be deeply gendered. Last week's the CBSE directive to schools to set up 'sugar boards' to monitor students' sugar intake got several thumbs up from nutritionists, paediatricians and non communicable disease specialists. Subba Rao M. Gavaravarapu and Bharati Kulkarni write specifically of Combating obesity among adolescents. Staying on the subject, R. Sujatha, writes about finding solutions through partnerships between engineering and biology for diabetes Do read on: Endocrinologists and engineers join hands to develop tech solutions for diabetes care . Dr. Y. Vijayachandra Reddy wrote on Understanding resistant hypertension and what can help on the occasion of World Hypertension Day (May 17), giving us insights into what is known as 'stubborn hypertension' and what specialised care is required to handle it. May is observed as Women's Health Month and to record that we had the following articles: Dr. D.C. Mathangi wrote about the struggle for work-life harmony among working women and how that impacts on her health. Meanwhile, Dr. Sapna Raina's piece on the occasion looks at the irrefutable link between Sleepless and pregnancy, and the impact on motherhood. Athira Elssa Johnson discusses Rising obesity among Indian women after a study called for science-based, community and lifecycle-oriented care. Moving on to an update on infectious diseases, the most prominent one, of course, is about COVID-19 resurgence. Bindu Shajan Perappadan quotes the Indian health ministry: COVID-19 cases see a surge in Singapore, Hong Kong; India reports 257 cases — all mild. We promise to follow this graph over the coming weeks. Abdul Latheef Naha's piece on yet another round of Nipah virus in Kerala: The return of the dread provides a great deal of information not only on this round, but on past episodes and the lessons learnt from those episodes. Do read this deep dive for clarity on the issue. There is the sobering news from across the seas about how Dengue, chikungunya may soon be endemic in Europe. There is no overemphasising the public health mantra 'no one is safe unless every one is safe' even as we grapple with the unexpected that climate change brings to us. This is a report on PM Modi's call for targeted interventions in TB elimination efforts. While chairing a high-level review meeting on the National TB Elimination Programme (NTEP), Mr. Modi urged officials to analyse TB patient data based on urban-rural distinctions and occupational categories. This will help identify vulnerable groups requiring early testing and treatment, especially workers in construction, mining, textile and other high-risk sectors, he said. In our e-paper column this week, we looked at the recent cough syrup ban in India, trying to understand the reasons behind it, and where we go from here. Rationalising a cough syrup ban in India, and steps ahead, is a collaborative story that draws from the experiences from many States. Paediatricians across the country have welcomed the move to restrict use of a common cold drug combination for children under the age of four and emphasised the need to not medicate unless warranted; pharmacists however, flagged confusion over whether prescriptions can be honoured and what should be done with existing stock. For more on the subject, do click on the link above. For the tailpiece of the week, you might accuse us of peddling monkey tales, but believe us, this one was serendipitously relevant to the patient, and our column. In our copy Monkey scare leads to unexpected diagnosis, facilitating treatment of a 32-year-old woman, we describe how in a striking turn of events, a routine day for a 32-year-old homemaker from Bengaluru turned into a life-saving diagnosis - thanks to a bizarre encounter with a monkey and the swift action of the neurosurgical team at a private hospital. While engaged in her daily chores, the woman was startled by a monkey that suddenly entered her home. In panic, she screamed and fainted suddenly. What followed was an intense, sudden headache medically known as a thunderclap headache. Initially hoping it was just a reaction to the panic, she tried to carry on. Finally she sought out a neurologist and was diagnosed with a brain aneurysm and subarachnoid haemorrhage, all of which were treated, happily for the patient. We also flag this book review, Untold Tales from a Physician's Bag, the partly humorous, partly dated memoirs of a practicing physician: Read on: An engaging medical memoir that sparks important questions. This week too, we have a big fat explainers section; you might find answers to long pending question, or even recent doubts here: Abhinay Lakshman explains Why there is variation in India's fertility rates? It is something we thought you might like to read about after the recently released Sample Registration Survey data, showed that Tamil Nadu, Delhi, Kerala have birth rates declining at twice the rate of national average. After Joe Biden was diagnosed with aggressive prostate cancer, Zubeda Hamid took some time to tell you All you need to know about prostate cancer. In the same series, she also wrote about urinary tract infections. Separately, she examines, in the In Focus podcast, Whether the 21 lakh 'excess deaths' in 2021 caused by the Covid19 pandemic? Last week we had told you about how records from the Civil Register showed that there were 21 lakh excess deaths during the year during COVID-19. Priyadarshini Paitandy spoke to experts to understand war anxiety and how to deal with it. Dr. C. Aravinda explains about the different parameters used to count health performance in India, in Estimates of existence: How does India count the lives of its citizens. In a series we started this May, we talk about the work that won people their Nobel Prize in Physiology or Medicine. This inaugural week, we have the first such Prize, and a note on Emil von Behring's contributions to serum therapy and tetanus vaccines. If you have an extra few minutes, do also read: Meena Putturaj The yearly 'thank you' to nurses is not enough My Science Quiz: On human physiology and mathematics India requires a social model of epilepsy care within school health programmes: experts WHO looks ahead to life after the US Why there needs to be more awareness about chronic fatigue syndrome in India — For many more health stories, head to our health page and subscribe to the health newsletter here.
Yahoo
20-05-2025
- Health
- Yahoo
FDA Approves First-Ever Blood Test for Alzheimer's—Here's What We Know
As of 2023, an estimated 6.7 million Americans aged 65 and older were living with Alzheimer's disease, according to the Alzheimer's Association. With that number projected to more than double to 13.8 million by 2060, the FDA has just approved the first blood test designed to help diagnose the disease—marking a major step forward in early detection and treatment. Manufactured by Fujirebio Diagnostics, the test will be used on individuals 55 and older who are currently exhibiting signs and symptoms of the disease. Alzheimer's disease is a type of dementia that affects memory and thinking capabilities. It may start with mild memory lapses like forgetting where your keys are, and eventually can turn into severe memory issues like forgetting loved ones. 'Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined,' FDA Commissioner Martin A. Makary, M.D., M.P.H., said in a press release. 'Knowing that 10% 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.' While there are several methods for diagnosing Alzheimer's, one of the most common is through the detection of amyloid plaques—or abnormal protein deposits that form between nerve cells in the brain. Traditionally, plaques are identified using amyloid PET scans, which are both expensive and time-consuming. Another option is a cerebrospinal fluid (CSF) test, which involves collecting CSF via an invasive lumbar puncture, or spinal new blood test takes the need for PET scans or spinal taps out of the equation by measuring the ratio of two proteins—pTau217 and β-amyloid 1-42. The ratio can help clinicians determine whether amyloid plaques are present in the brain. In a clinical study, 91.7% of people who received a positive blood test result also had amyloid plaques confirmed by a PET scan or CSF test. 97.3% of people who got a negative blood test result also had no amyloid plaques according to the PET or CSF test. The results indicate that the test is a reliable way to detect and rule out amyloid plaques without the need for invasive strategies like brain scans or spinal taps. 'Nearly 7 million Americans are living with Alzheimer's disease, and this number is projected to rise to nearly 13 million,' said Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. 'Today's clearance is an important step for Alzheimer's disease diagnosis, making it easier and potentially more accessible for U.S. patients who are earlier in the disease.' According to the FDA, the main concern with the blood test is the possibility of a false positive, which "could lead to an inappropriate diagnosis of, and unnecessary treatment for Alzheimer's disease." It's also important to note that this new blood test is not intended to be used as a stand-alone diagnostic test and should be utilized in conjunction with other clinical evaluations or additional testing.
