Latest news with #MichelleTarver
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
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.
India Today
19-05-2025
- Health
- India Today
US FDA approves first blood test to diagnose Alzheimer's disease
The US has approved its first-ever blood test to help detect Alzheimer's disease in its early stages, offering hope to millions facing the devastating neurological disease is the most common type of dementia in which a person's brain begins to shrink as they age. This brain disorder leads to memory loss and cognitive of this disease worsen over time. The disease is believed to occur due to the presence of two types of protein in the brain: amyloid plaques and tau Currently, there's no cure for Alzheimer's, but medicines have been approved that slow the disease new blood test, developed by Fujirebio Diagnostics, works by measuring the ratio of the two specific proteins in the blood (amyloid and tau). Alzheimer's disease is believed to occur due to the presence of two types of protein in the brain: amyloid plaques and tau plaques. () Until now, these plaques could only be identified through costly PET scans or invasive spinal fluid US Food and Drug Administration (FDA) announced the approval on Friday, marking what experts believe could be a turning point in how the disease is diagnosed and disease impacts too many people, more than breast cancer and prostate cancer combined,' said FDA Commissioner Dr. Marty added, '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.'EARLIER DETECTION MEANS BETTER TREATMENTThe new blood test is not a standalone diagnostic tool, it is approved for use in clinical settings for patients who are already showing signs of cognitive it promises a simpler and more accessible method to screen for the disease, which could allow doctors to confirm Alzheimer's earlier and begin treatment when it's most are currently two FDA-approved drugs, lecanemab and donanemab, that target the amyloid plaques associated with Alzheimer's. While not cures, these treatments have shown they can modestly slow the disease's progression, especially when started early. That makes timely diagnosis and Alzheimer's advocates say the blood test could help reduce the time it takes to get patients into treatment."Today's clearance is an important step for Alzheimer's diagnosis. It makes the process easier and potentially more accessible for U.S. patients earlier in the disease," said Dr. Michelle Tarver of the FDA's Center for Devices and Radiological AND LESS INVASIVEIn clinical studies, the blood test performed comparably to more traditional diagnostic tools like PET scans and spinal the study, the new blood test correctly showed signs of Alzheimer's in about 92 out of 100 people who really had it, and correctly showed no signs in about 97 out of 100 people who didn't have it. In clinical studies, the blood test performed comparably to more traditional diagnostic tools like PET scans and spinal taps. () Only a small number of people, less than 1 in 5, got unclear results from the means the blood test is quite accurate in finding out whether someone has the early brain changes linked to Alzheimer's, especially in people who are already showing memory problems, or the test should only be used in hospitals or clinics where specialists can check for memory issues, and it should always be used along with other health information from the patient, the FDA report main risk of this test is that it could sometimes give wrong results, either saying someone has signs of Alzheimer's when they don't (false positive), or missing the disease when it's actually there (false negative). The test should only be used in hospitals or clinics where specialists can check for memory issues. () Alzheimer's gradually erodes memory, decision-making ability, and eventually, the population ages, the number of people affected by the disease is projected to grow blood test could also help reduce the emotional and financial toll of delayed diagnosis, something many families experience when symptoms are mistaken for normal aging or are missed the test is not yet widely available, its FDA approval opens the door for broader adoption in hospitals and clinics across the country, say Reel
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First Post
19-05-2025
- Health
- First Post
Blood test to diagnose Alzheimer's gets approval in US
Fujirebio Diagnostics created the test to assess the ratio of two proteins in the blood. The rato is associated with amyloid plaques in the brain, a hallmark of Alzheimer's that has thus far been diagnosed exclusively by brain imaging and spinal fluid research read more The US approved the first blood test for Alzheimer's on Friday, potentially allowing patients to begin treatment sooner using newly approved medications that slow the spread of the terrible neurological illness. Fujirebio Diagnostics created the test to assess the ratio of two proteins in the blood. The rato is associated with amyloid plaques in the brain, a hallmark of Alzheimer's that has thus far been diagnosed exclusively by brain imaging and spinal fluid research. STORY CONTINUES BELOW THIS AD 'Alzheimer's disease impacts too many people – more than breast cancer and prostate cancer combined,' said Food and Drug Administration Commissioner Marty Makary. 'Knowing that 10 percent 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 they do not cure Alzheimer's, lecanemab and donanemab, two FDA-approved therapies that target amyloid plaque, have been demonstrated to somewhat moderate cognitive deterioration. Advocates of intravenous antibody treatments, including many neurologists, claim they can provide patients a few more months of independence and are more likely to be beneficial if begun earlier in the disease's course. In clinical trials, the blood test showed results that were mostly consistent with positron emission tomography (PET) brain scans and spinal fluid analyses. 'Today's clearance is an important step for Alzheimer's diagnosis, making it easier and potentially more accessible for US patients earlier in the disease,' said Michelle Tarver of the FDA's Center for Devices and Radiological Health. The test is authorized for use in clinical settings for patients showing signs of cognitive decline, and results must be interpreted alongside other clinical information. Alzheimer's is the most common form of dementia. It worsens over time, gradually robbing people of their memories and independence.
The Hindu
18-05-2025
- Health
- The Hindu
US approves first blood test for Alzheimer's
The United States on 16 May 2025 approved the first blood test for Alzheimer's, a move that could help patients begin treatment earlier with newly approved drugs that slow the progression of the devastating neurological disease. How does the test work 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. "Alzheimer's disease impacts too many people -- more than breast cancer and prostate cancer combined," said Marty Makary, Food and Drug Administration Commissioner. "Knowing that 10 percent 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." 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. Advocates for the intravenous antibody therapies, including many 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. Results and future possibilities In clinical studies, the blood test produced results largely in line with positron emission tomography (PET) brain scans and spinal fluid analysis. "Today's clearance is an important step for Alzheimer's diagnosis, making it easier and potentially more accessible for US patients earlier in the disease," said Michelle Tarver of the FDA's Center for Devices and Radiological Health. The test is authorised for use in clinical settings for patients showing signs of cognitive decline, and results must be interpreted alongside other clinical information. Alzheimer's is the most common form of dementia. It worsens over time, gradually robbing people of their memories and independence.
