Latest news with #PrecivityAD2
Ammon
18-05-2025
- Health
- Ammon
US clears first blood test for Alzheimer's detection
Ammon News - The U.S. Food and Drug Administration has cleared Fujirebio Diagnostics' blood test to diagnose Alzheimer's disease, the regulator said on Friday, making the device the first of its kind to detect the brain-wasting condition. Blood tests could speed up diagnosis of the disease and make it easier for more people to access its treatments such as Biogen and Eisai's Leqembi and Eli Lilly's Kisunla, since traditional tests are often costly or uncomfortable. Fujirebio's test, branded as Lumipulse, checks for two proteins in the blood and uses their ratio to help detect signs of amyloid beta plaque, considered a hallmark of the disease, in the brain. Other options to detect Alzheimer's include procedures such as a spinal tap, which requires an invasive puncture to collect spinal fluid, or an expensive PET brain scan that may not be reimbursed by health insurers. "Street expectations for both therapies (Leqembi and Kisunla) are modest" with a slow ramp over the next few years, given the lack of access to neurologists, said Citi analyst Geoffrey Meacham. "An approved blood-based diagnostic is a positive in a disease area that has been starved of game-changing innovation." Biogen has been doubling down on Leqembi but it has failed to live up to lofty expectations due to concerns over cost, efficacy and side effects. In the first quarter, Leqembi brought $96 million in sales, while Lilly recorded $21.5 million in Kisunla sales. Lumipulse and C2N Diagnostics' PrecivityAD2 were the top two performers when compared with four other commercial blood tests for Alzheimer's, according to a study led by researchers at Washington University School of Medicine.
Time of India
17-05-2025
- Health
- Time of India
US FDA clears first blood test for Alzheimer's detection
Bengaluru: The U.S. Food and Drug Administration has cleared Fujirebio Diagnostics ' blood test to diagnose Alzheimer's disease, the regulator said on Friday, making the device the first of its kind to detect the brain-wasting condition. Blood tests could speed up diagnosis of the disease and make it easier for more people to access its treatments such as Biogen and Eisai's Leqembi and Eli Lilly's Kisunla, since traditional tests are often costly or uncomfortable. Fujirebio's test, branded as Lumipulse, checks for two proteins in the blood and uses their ratio to help detect signs of amyloid beta plaque, considered a hallmark of the disease, in the brain. Other options to detect Alzheimer's include procedures such as a spinal tap, which requires an invasive puncture to collect spinal fluid, or an expensive PET brain scan that may not be reimbursed by health insurers. "Street expectations for both therapies (Leqembi and Kisunla) are modest" with a slow ramp over the next few years, given the lack of access to neurologists, said Citi analyst Geoffrey Meacham. "An approved blood-based diagnostic is a positive in a disease area that has been starved of game-changing innovation." Biogen has been doubling down on Leqembi but it has failed to live up to lofty expectations due to concerns over cost, efficacy and side effects. In the first quarter, Leqembi brought $96 million in sales, while Lilly recorded $21.5 million in Kisunla sales. Lumipulse and C2N Diagnostics' PrecivityAD2 were the top two performers when compared with four other commercial blood tests for Alzheimer's, according to a study led by researchers at Washington University School of Medicine. Biogen has partnered with Fujirebio, and Eisai is collaborating with C2N to clinically advance and commercialize blood tests that can detect Alzheimer's risk.
Indian Express
16-05-2025
- Health
- Indian Express
US FDA clears first blood test to detect Alzheimer's disease
The US Food and Drug Administration said on Friday it had cleared Fujirebio Diagnostics' blood test to diagnose Alzheimer's disease, making the test the first of its kind to detect the condition. The blood test, branded as Lumipulse, will initially likely be used to rule out Alzheimer's, with positive results signaling the need for more advanced diagnostics. Alzheimer's, which gradually destroys memory and thinking skills, is characterized by certain changes in the brain, including a buildup of amyloid beta plaques that result in loss of neurons responsible for transmitting information. Fujirebio's device measures two specific proteins in the blood, pTau217 and β-amyloid 1-42, and calculates a ratio between them. This ratio is linked to the presence of amyloid plaques in the brain, which is a key sign of Alzheimer's. Detecting these plaques usually requires a PET brain scan or a spinal tap, which is a more invasive procedure to collect fluid from the spine. Lumipulse only needs a blood draw, making it much easier and more comfortable for patients, the FDA said. 'Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined,' said FDA Commissioner Martin Makary. '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.' Lumipulse and C2N Diagnostics' PrecivityAD2 were the top two performers when compared with four other commercial blood tests for Alzheimer's, according to a study led by researchers at Washington University School of Medicine. The FDA has approved Biogen and partner Eisai's Leqembi and Eli Lilly's Kisunla for the treatment of this disease.
Time of India
16-05-2025
- Health
- Time of India
US FDA clears first blood test to detect Alzheimer's disease
Live Events (You can now subscribe to our (You can now subscribe to our Economic Times WhatsApp channel The U.S. Food and Drug Administration said on Friday it had cleared Fujirebio Diagnostics ' blood test to diagnose Alzheimer's disease , making the test the first of its kind to detect the blood test, branded as Lumipulse, will initially likely be used to rule out Alzheimer's, with positive results signaling the need for more advanced which gradually destroys memory and thinking skills, is characterized by certain changes in the brain, including a buildup of amyloid beta plaques that result in loss of neurons responsible for transmitting device measures two specific proteins in the blood, pTau217 and β-amyloid 1-42, and calculates a ratio between ratio is linked to the presence of amyloid plaques in the brain, which is a key sign of Alzheimer' these plaques usually requires a PET brain scan or a spinal tap, which is a more invasive procedure to collect fluid from the only needs a blood draw, making it much easier and more comfortable for patients, the FDA said."Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined," said FDA Commissioner Martin Makary."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."Lumipulse and C2N Diagnostics' PrecivityAD2 were the top two performers when compared with four other commercial blood tests for Alzheimer's, according to a study led by researchers at Washington University School of FDA has approved Biogen and partner Eisai's Leqembi and Eli Lilly's Kisunla for the treatment of this disease. (Reporting by Christy Santhosh in Bengaluru; Editing by Shreya Biswas and Shailesh Kuber)
