First blood test for Alzheimer’s disease now on market FDA approval

One company has begun promoting the first blood test to help diagnose Alzheimer’s disease, a break in the box that can help many others know if they have dementia. It also raises considerations about the accuracy and effect of this life change. News.

Independent experts are cautious because the effects of key controls have not been published and the check has not been approved by the US Food and Drug Administration. U. S. , Sold in accordance with more general regulations for advertising labs, but agree that an undeniable check that can be made on a doctor has long been necessary.

“I think there are two key steps that need to be taken before this verification is generalized,” dr. Karen Abrashkin, internal medicine specialist, at CBSN. ” The first is that we want to see the knowledge used to expand the verification. We’ve noticed that knowledge yet. They have been published, so we know how delicate or express this control is for Alzheimer’s disease. “

The other, for Abrashkin, is FDA approval.

“It’s a seal of approval that you want to take a position before testing becomes common,” he said.

A check that may have kept Tammy Maida a decade of fruitless travel to doctors who attributed their symptoms to depression, anxiety or menopause before a $5,000 brain scan last year, even though it all showed that he had Alzheimer’s disease.

“Now I have an answer,” said former 63-year-old nurse from San Jose, California.

If a blood test had been available, “I have been afraid of the results,” yet I would have “jumped on it” to locate it, he said.

More than five million people in the United States and millions more worldwide suffer from Alzheimer’s disease, the maximum non-unusual form of dementia. To be diagnosed, other people will need to have symptoms such as loss of reminiscence and evidence of protein buildup called beta-amyloid in the brain.

The most productive way to measure protein now is an expensive PET scan that isn’t covered by insurance, which means other people don’t have one and wonder if their disorders are due to general aging, Alzheimer’s disease or anything else.

Blood test for C2N Diagnostics in St. Louis aims to fill this void. The company’s founders come with the Dr. David Holtzman and Randall Bateman of the University of Washington School of Medicine, who led the studies that led to verification and are included in a patent that the University of St. Legal Louis at C2N.

The check is not intended for general screening or for others without symptoms; it is for others over the age of 60 who have mirrored imaging disorders and are being evaluated for Alzheimer’s disease. Not covered by insurance or Medicare; The company charges $1,250 and offers income-based discounts. Only doctors can request the check and the effects come within 10 days. It is sold in almost every state in the United States and has just been authorized for sale in Europe.

It measures two types of amyloid waste and protein bureaucracy that reveal whether someone has a gene that increases the threat of disease. These points are combined into a formula that includes age and patients get a score that suggests a low, medium or high level. probability of amyloid buildup in the brain.

If the check puts them in the lower category, “it’s an explanation of why look for other things” besides Alzheimer’s disease, Bateman said.

“There are thousands of things that can cause cognitive decline,” from vitamin deficiencies to medications, Holtzman said.

“I don’t think it’s another of the checks we’re doing at the moment,” unless it’s from a blood test rather than a brain scan, he said. “And those aren’t one hundred percent accurate either. “

Although there is still no cure for the disease, Dr. Abrashkin agreed that the purpose of early detection is important.

“Understanding whether it’s Alzheimer’s disease, there are other tactics for others with Alzheimer’s disease and, in the long run, there may be more remedies for Alzheimer’s disease,” he said. “It is equally vital to perceive when someone does not have Alzheimer’s disease, to exclude them and look for other reasons of cognitive decline.

The company did not publish any knowledge of the accuracy of the check, doctors published on the amyloid studies that led to the check. 60 to 91, with cognitive impairment or dementia.

If a positron emission tomography scan showed a buildup of amyloid, the blood test also showed a peak probability in 92% of cases and lacks 8%, said the company’s CEO, Dr. Joel Braunstein.

If the PET test is negative, the blood test excluded amyloid buildup 77% of the time, the remaining 23% tested positive, but that doesn’t necessarily mean the blood test is incorrect, Braunstein said. Published studies suggest that it may run into amyloid accumulation. before it is evident in the explorations.

Braunstein said the company will seek FDA approval and the company has given it a designation that would possibly expedite the review. He said the effects of the review would be released and defended the resolve to begin promoting the check now.

“Should we retain this generation when it can have a significant effect on patient care?” he asked.

Dr. Eliezer Masliah, head of neuroscience at the U. S. National Institute on Aging, is a member of the U. S. Institute on Aging. The U. S. , he said the government had funded some of the paintings that led to control, as well as others of blood.

“I’d be careful to interpret one of those things,” he said of the company’s claims. “We are animated, we are interested, we finance these paintings and we are yet to see results. “

Heather Snyder of the Alzheimer’s Association said she would not pass a check without FDA approval. The check should also be studied in larger and more varied populations.

“It’s transparent how precise or widespread the effects are,” he said.

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