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(Bloomberg)-American regulators have first approved blood tests to help diagnose Alzheimer’s disease, possibly it becomes easier and treating patients with mind-rubbing disease and treating patients that affect about 7 million Americans.
The US Food and Drug Administration said in a statement that the test conducted by Fujirebio Diagnostics Inc., a unit of Japan’s HU Group Holdings Inc., was approved for people aged 55 years and older. It is designed for early detection of amyloids, a protein that can build in the brain and an identity of Alzheimer’s, which is the most common form of dementia in the elderly.
The development and approval of blood tests that can spot that patients are likely to be toxic amyloid in their brain, have been seen as an important step towards creating drugs to consider more widely accessible of the condition. While the test is approved for those who are already demonstrating signs of cognitive loss, the study suggests that amiloid begins to accumulate in the brain of some patients, which begins the symptoms before the years.
To qualify for drug treatment, patients now generally get a special PET scan in their brain to detect amyloids or go through cerebrospinal fluid tests. PET scans are expensive and require special equipment, while spinal fluid tests include an aggressive process.
The requirement of these tests has slowed the rollouts of new Alzheimer’s drugs such as the Christian company and the biogen ink and Elli Lily & Co. from Kisunla to Lekembi.
The newly approved test of the phujirebio, called lumipulus, requires only a blood draw, making patients less aggressive and potentially easier to reach. It is not clear how much it will cost or when it will be available. This is for patients in a special care setting that experience cognitive decline according to the FDA.
The agency stated that blood tests should not be used alone to diagnose the disease, because due to the risk of false positive or negative consequences, the agency said. Other clinical evaluation and additional tests should be used to determine treatment options, it is said.
Such more stories are available on bloomberg.com
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