Lumipulse: An In-Vitro Diagnostic Test Alzheimer’s Disease

Last Updated: May 20, 2022


What is Lumipulse?

 Lumipulse was approved in May 2022 by the FDA to screen for Alzheimer’s disease.

Lumipulse is a test that acts as an early detector for Alzheimer’s disease. It helps persons 55 and over determine in an inexpensive, non-invasive way if they have the benchmarkers for Alzheimer’s. This test measures the amyloid-beta proteins that appear in one’s system. Amyloid-beta is a protein that occurs naturally in healthy brains but forms clumps or tangles between the brain cells of people with Alzheimer’s disease. This causes cellular death that leads to Alzheimer’s symptoms. By catching symptoms early, Lumipulse can help in a better quality of life for our loved ones. Options for early treatment and planning help make the disease easier to manage.


How Does Lumipulse Test for Alzheimer’s?

Lumipulse is an in-vitro test. In vitro means the testing is done in a tube or dish and tested in a controlled setting, like a lab. This kind of testing is used frequently from pregnancy tests to cholesterol testing.

Lumipulse is testing for amyloid-beta proteins. In Alzheimer’s patients, these proteins form clumps making brain cells to die. The disease causes a buildup of amyloid-beta proteins in the brain. Through testing cerebral spinal fluid, Lumipulse is looking for elevated protein levels to diagnose early or pre stages of Alzheimer’s disease.


Pros & Cons of the Lumipulse Test

Being able to detect Alzheimer’s disease earlier, is one of Lumipulse’s many advantages. The other main benefit is that this test would replace the current use of PET scans. Currently they determine elevated levels of amyloid-beta proteins through brain imaging. PET scans are costly (averaging $5,000 to $6,000) and have a risk of radiation exposure. In comparison, Lumipulse can test and be interpreted by a doctor on the same day. This enables doctors to properly diagnose patients in a faster, cheaper way.

While there are not many cons for Lumipulse, it needs to be noted that this non-invasive test must be performed together with other medical evaluations. This is necessary to determine that a positive result is not given in error. Potentially, the only risk with a false positive or negative would be too much or too little treatment. Other types of dementia could test positive for elevated amyloid-beta proteins in the brain and also healthy older individuals can naturally have higher levels of the protein that are not toxic to them.


Effectiveness of the Lumipulse Test

In the process of Lumipulse getting FDA approval, it underwent a double check of the efficiency of the test. The FDA reviewed samples and did their own lab testing. They tested 292 samples and their results were in line with what Lumipulse reported. The FDA found that 97% of all positive Lumipulse diagnostic tests also tested positive for Alzheimer’s through PET scans. In addition, 87% of the negative results also tested negative via brain imaging.


When Will the of the Lumipulse Test Be Available to the Public?

As with all new treatments in the fight against Alzheimer’s disease, an important question arises, when can this help my loved one? At this time, we do not know. The company that makes Lumipulse, Fujirebio Diagnostics, has not said when they are releasing this new diagnostic tool.


Cost & Medicare and Medicaid Coverage of the Lumipulse Test

Normally after FDA approval, cost and insurance coverage eligibility are determined. At this point, there is still no information on its financial effect. Fujirebio, the makers of Lumipulse, have not advertised its price.

FDA approval is vital for determining if this new diagnostic test will be covered by insurance. At this point there is no information. It is not known if Medicare, Medicaid and/or private insurance will cover Lumipulse or if it will be an out-of-pocket expense.