In an unprecedented move, the United States Food and Drug Administration (FDA) just approved an innovative blood test. This new test will address doctors’ and patients’ needs by accelerating Alzheimer’s disease diagnosis. The Lumipulse blood test is an exciting new diagnostic resource. It is a significant step in the right direction for Alzheimer’s diagnostics. This novel test is noninvasive, using a simple blood draw as an alternative to more invasive CSF collection. By communicating across modalities, it seeks to reduce time and cost in the diagnostic process and avoid unnecessary invasive biopsies.
The Lumipulse blood test works by measuring the levels of two specific proteins in the blood: phosphorylated tau (pTau 217) and beta-amyloid 1-42. The ratio of these proteins in concentration is increasingly important in determining the presence of amyloid plaques in the brain. These plaques are widely known as the hallmark sign of Alzheimer’s disease. Amyloid plaques are thought to disrupt communication between neurons, causing the memory loss and other symptoms of Alzheimer’s.
This new paradigm democratizes the testing process greatly. By requiring only a blood sample instead of a CSF sample, it eliminates the need for lumbar punctures—a procedure that many patients find invasive and uncomfortable. Clinical guidance indicates that less than 20% of patients receiving a positive Lumipulse test result need further invasive testing. These tests often require invasive procedures, such as lumbar punctures or PET scans, to corroborate their diagnosis.
Dr. Manisha Parulekar, director of the Division of Geriatrics at Hackensack University Medical Center, emphasized the importance of this development. She mentioned how the blood test would help get people diagnosed much earlier, sometimes saving young women and men years of being undiagnosed.
“The less invasive nature of a blood test will likely encourage more people experiencing mild cognitive impairment or early symptoms to seek testing,” – Manisha Parulekar, MD, FACP, AGSF, CMD
Dr. Parulekar further elaborated that making a diagnosis as early as possible is key to making the most of existing and developing treatments. These blood tests are inexpensive to produce and widely accessible. This can increase their accessibility to more individuals, especially for those living in disadvantaged neighborhoods.
Yet, it is important for people to understand that the Lumipulse blood test was not designed to be a screening test. It should be used however in conjunction with relevant diagnostic protocols and as part of a battery of cognitive assessments. Experts urge caution in interpreting the results.
Dr. Clifford Segil, a neurologist in private practice in Santa Monica, CA, expressed his apprehension. For this reason, he frets over the test being weaponized. He cautioned that primary care physicians might quickly label patients as having Alzheimer’s dementia based on blood tests alone. They need to weigh other key variables before jumping to an explanation.
“My first response to this blood test is concern that primary care physicians are going to diagnose patients with Alzheimer’s dementia from a blood test who have no memory loss or risk factors for dementia,” – Clifford Segil, DO
Dr. Segil had further concerns regarding the approval process for this test. He pointed out that the FDA’s Breakthrough Devices Program cleared it. This program provides for expedited reviews, but may not be held to the same stringent standards as traditional pathways.
“And tests like this, which were not approved by the typical rigorous FDA pathway but rather through an abbreviated process via the FDA’s ‘Breakthrough Pathway,’ cause me concern that countless people are going to be told they have dementia per a blood test when they do not have dementia,” – Clifford Segil, DO
Dr. Gediminas Gliebus, director of cognitive and behavioral neurology at Marcus Neuroscience Institute, expressed optimism about the new test’s potential impact on diagnosing Alzheimer’s disease. He shone a light on how the Lumipulse test’s noninvasive nature should help result in more timely interventions.
“I was genuinely excited to hear about the FDA’s clearing of this blood test, as it represents a significant advancement in simplifying the evaluation of patients who present with symptoms that might suggest Alzheimer’s disease,” – Gediminas Gliebus, MD
Dr. Gliebus stressed how this test only requires a basic blood sample. This new development increases access and allows for diagnosis to be made at earlier ages. He especially noted that more preventive interventions could contain or delay disease progression.
The Lumipulse blood test brings new hope not just for individual patients, but for research progress worldwide in Alzheimer’s disease. Dr. Bhavana Patel lauded its potential in clinical trials targeting participants with early-stage Alzheimer’s disease. She said more research is needed before endorsing it for widespread screening.
“This test has potential for use in pre-screening participants in clinical trials for early stages of Alzheimer’s disease; however, its application in primary care settings is not yet fully understood,” – Bhavana Patel, DO
She cautioned that this new test could lead to an increase in false positives and false negatives. This further emphasizes the need to conduct it, at a minimum, along with cognitive assessments.
“As with many tests, false positives and false negatives can occur. Therefore, this test should be done in the setting of cognitive symptoms and with a specialist who can accurately interpret and counsel on the results,” – Bhavana Patel, DO
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