Latest news with #FujirebioDiagnostics'
Engadget
16-05-2025
- Health
- Engadget
The FDA clears the first blood test for diagnosing Alzheimer's disease
There's a new way to screen for early detection of Alzheimer's disease. On Friday, the Food and Drug Administration (FDA) cleared the first blood test for the disorder. Fujirebio Diagnostics' Lumipulse measures the ratio of two proteins that correlate with the presence or absence of Alzheimer's. Previously, patients being screened for Alzheimer's were limited to more invasive options: a PET Scan or spinal tap. Lumipulse is intended for use in clinical settings with patients exhibiting signs of cognitive decline. At least in its current form, it isn't something the general population can ask for as a standard screening. The test works by measuring two proteins: pTau217 and β-amyloid 1-42. The blood test calculates their ratio, which correlates with the buildup of amyloid plaques in the brain. People with Alzheimer's have elevated pTau217 and lower β-amyloid 1-42. In a clinical study, the test performed better with negative results than positive ones. As such, Reuters reports that the test will likely be used initially to rule out Alzheimer's. Over 97 percent of negative results corresponded with a negative PET scan or CSF test result. Results for positives were a bit lower: a 91.7 percent correlation. So, positive results will need to be confirmed with more advanced diagnostic tests.
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.
Yahoo
16-05-2025
- Health
- Yahoo
US FDA clears first blood test to detect Alzheimer's disease
(Reuters) -The U.S. Food and Drug Administration said on Friday it has cleared Fujirebio Diagnostics' blood test to diagnose Alzheimer's disease, making it the first of its kind to detect the condition. Blood testing is initially likely to 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 changes in the brain including buildup of amyloid beta plaques and tau tangles that result in loss of neurons responsible for transmitting information. Fujirebio's diagnostic device, will be used for early detection of amyloid plaques associated with the disease.
