The FDA approves the first Alzheimer’s blood test

Alzheimer’s disease develops over many years, long before the symptoms were obvious, but the lack of accessible and mini-invasive diagnostic tests leads to many people not diagnosed until the disease is well advanced, while few effective interventions remain.
“This test is a revolution in Alzheimer’s disease both from a diagnostic and treatment point of view,” explains Howard Fillit, MD, co -founder and scientific director of Alzheimer’s Drug Discovery Foundation (ADDF). “Even 5 or 10 years ago, I never thought there would be a blood test for Alzheimer’s disease, so it is really incredible progress.”
The Alzheimer’s blood test was very precise in clinical trials
The researchers found that almost 92% of people who were tested positive for amyloid plates with the Lumipulse test also had evidence of amyloid plates verified by TEP analyzes or vertebral taps.
Just over 97% of people with negative results of the Lumipulse test had negative amyloid trifling or a vertebral loft result.
Less than a fifth of the 499 patients tested received an indefinite lumipulse result.
The FDA noted that the results of the Lumipulse blood test were “significantly equivalent” to a similar and previously authorized lumipulse test which uses samples of vertebral lift.
The blood test for Alzheimer’s disease could make the diagnosis easier and more easily available
TEP analyzes and vertebral taps are very precise when it comes to identifying amyloid plates – but they are costly, invasive, long and can have limited availability, according to Dr Fillit.
He estimates a blood analysis as the Lumipulse test could cost $ 500 to $ 1,000. A TEP, however, can cost up to $ 6,000 to $ 8,000. A blood sample is also much easier and less long than brain imaging, and it does not expose a patient to radiation.
Monte Wiltse, president and chief executive officer of Fujirebio Diagnostics, the manufacturer of the blood test, expects that the tool can help more people get an official diagnosis earlier so that they can receive appropriate treatment, including drugs that can slow the progress of Alzheimer.
A new promising piece with diagnostic puzzle
Increasingly, specialists in clinical areas use blood tests as a first -range detection tool. The Alzheimer’s association says that blood tests could become a more common element in the diagnostic process, as well as medical history, neurological examinations and cognitive and functional assessments.
We still do not know how health care providers will incorporate the Lumipulse test into daily practice, according to Fillit.
“There have been medical documents that answer this question: what happens when a person undergoes a positive blood test?” Does he need a brain analysis? I do not think that this problem was entirely resolved by organizations such as the American Academy of Neurology and the American College of Physicians, “he said.
“This is only the beginning of a real revolution of the way in which the diagnosis will be made. While blood biomarkers continue to evolve, they will fundamentally reshape the Alzheimer’s care landscape, creating a new landscape where precision medicine and the prevention of the disease are possible,” explains Fillit.
A new blood test can be popular
Access to treatment and early care is the main reason mentioned to want a simple test.