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Business Standard
20-05-2025
- Health
- Business Standard
First blood test for Alzheimer's in US from June, starting at 50 hospitals
The first blood test to help diagnose Alzheimer's disease will be available from late June in the US following regulatory clearance for its use last week, according to the Japanese company behind the innovation. The test will initially be available at about 50 American research institutes and hospitals that specialize in Alzheimer's disease, Goki Ishikawa, head of Fujirebio Diagnostics Inc. that developed the test, said in an interview Tuesday. The company, a unit of Japan's H.U. Group Holdings Inc., is also partnering with bigger rivals like Beckman Coulter Inc. to help develop and manufacture their products, he said. The Food and Drug Administration cleared the blood test to help diagnose Alzheimer's disease last week, potentially making it easier to find and treat patients with the memory-robbing disease that affects nearly 7 million Americans. The test was cleared for use in people at least 55 years old and who exhibit signs of the disease. It is designed to detect amyloid, a protein that can build up in the brain and is a hallmark of Alzheimer's, the most common form of dementia in the elderly. The process, which takes roughly 30 minutes from drawing the blood to diagnosis, will be available to patients at a fraction of the cost of a PET scan. The method is viewed as a critical step in making new types of Alzheimer's treatments widely accessible. Until now, patients typically have to get a specialized PET scan to detect amyloid in their brains or undergo cerebrospinal fluid tests, both of which are more expensive and invasive. The lack of quick and easy tests has until now slowed the rollout of new Alzheimer's drugs like Eisai Co. and Biogen Inc.'s Leqembi and Eli Lilly & Co.'s Kisunla. The company plans to file data to seek approvals in Japan as early as August and Europe within this year, Ishikawa said. In China, Fujirebio's undisclosed partner will probably submit data to regulators next year, he added. In India, it partners with Agappe Diagnostics Ltd. 'We have a presence in Japan but that's not necessarily the case in markets overseas,' said Ishikawa. 'We can't get the market shares by ourselves, but if we supply the raw materials to partners, we can benefit through them.'
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
Mint
16-05-2025
- Health
- Mint
FDA Approves First Blood Test to Diagnose Alzheimer's Disease
(Bloomberg) -- US regulators have approved the first blood test to help diagnose Alzheimer's disease, potentially making it easier to find and treat patients with the mind-robbing disease that affects nearly 7 million Americans. The test made by Fujirebio Diagnostics Inc., a unit of Japan's H.U. Group Holdings Inc., was cleared for people 55 years and older who exhibit signs and symptoms of the disease, the US Food and Drug Administration said in a statement. It is designed for the early detection of amyloid, a protein that can build up in the brain and is a hallmark of Alzheimer's, the most common form of dementia in the elderly. The development and approval of blood tests that can spot which patients are likely to have toxic amyloid in their brains has been viewed as a critical step toward making drugs to treat the condition more widely accessible. While the test is approved for people who are already exhibiting signs of cognitive impairment, studies show amyloid begins accumulating in the brains of some patients years before symptoms begin. To qualify for drug treatment, patients now generally get a specialized PET scan to detect amyloid in their brains or undergo a cerebrospinal fluid test. The PET scans are expensive and require specialized equipment, while the spinal fluid tests involve an invasive procedure. The need for these tests has slowed the rollout of new Alzheimer's drugs like Leqembi from Eisai Co. and Biogen Inc., and Eli Lilly & Co.'s Kisunla. Fujirebio's newly approved test, called Lumipulse, only requires a blood draw, making it less invasive and potentially easier for patients to access. It's unclear how much it will cost or when it will be available. It's intended for patients at a specialized care setting who are experiencing cognitive decline, according to the FDA. The blood test shouldn't be used alone to diagnose the disease, in part because of the risk of false positive or negative results, the agency said. Other clinical evaluations and additional tests should be used to determine treatment options, it said. More stories like this are available on
