The FDA has authorized the marketing of a new diagnostic test designed for the early detection of Alzheimer’s disease.
The test is intended for use in adult patients, ages 55 and older, who have symptoms of cognitive impairment and are being evaluated for Alzheimer’s disease and other causes of cognitive decline.
The test, considered an in vitro Lumipulse test, is designed to reduce the time and expense typically associated with Alzheimer’s testing.
“The availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive PET scans is great news for individuals and families concerned about the possibility of a diagnosis of Alzheimer’s disease,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.
“With the Lumipulse test, there is a new option that can usually be completed the same day and can give doctors the same information about the amyloid status of the brain, without the risk of radiation, to help determine if a person’s cognitive impairment patient is due to Alzheimer’s disease. ”
According to National Institutes of Health, more than six million Americans, most aged 65 or older, may have dementia caused by Alzheimer’s disease, a brain disorder known to slowly destroy memory and thinking skills, and, eventually, the ability to perform the simplest tasks. In most people with Alzheimer’s disease, the first clinical symptoms appear later in life.
Alzheimer’s disease is progressive, which means that the disease gets worse over time. Early and accurate diagnosis is important to help patients and caregivers with planning and early treatment options.
There is an unmet need for a reliable and safe test that can accurately identify patients with amyloid plaques consistent with Alzheimer’s disease. Although amyloid plaques can occur in other diseases, being able to detect the presence of plaque, along with other assessments, helps the physician determine the likely cause of the patient’s symptoms and findings.
Prior to this clearance, physicians used Positron Emission Tomography (PET), a potentially expensive and time-consuming option, to detect/visualize amyloid plaques in a patient’s brain, often years before the onset of clinical symptoms. to aid in the diagnosis of Alzheimer’s disease.
The Lumipulse test is intended to measure the ratio of concentrations of β-amyloid 1-42 and β-amyloid 1-40 (specific proteins that can accumulate and form plaques) found in human cerebrospinal fluid (CSF) , which can help doctors determine if a patient is likely to have amyloid plaques, a hallmark sign of Alzheimer’s disease. The results should be interpreted in conjunction with the patient’s other clinical information.
A positive Lumipulse G β-amyloid ratio test result (1-42/1-40) is consistent with the presence of amyloid plaques, similar to what one would see on a PET scan. A negative result is consistent with a negative amyloid PET result. A negative test result reduces the likelihood that a patient’s cognitive impairment is due to Alzheimer’s disease, allowing doctors to look for other causes of cognitive decline and dementia.
The test is not intended as a stand-alone screening or diagnostic test. It is also possible that a positive test result may be seen in patients with other types of neurological disorders, as well as in cognitively healthy older adults, which underscores the importance of using this test in conjunction with other clinical assessments.
The FDA evaluated the safety and effectiveness of this test in a clinical study of 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative sample bank. Samples were tested by Lumipulse G β-amyloid Ratio (1-42/1-40) and compared to amyloid PET results.
In this clinical study, 97% of individuals with positive results on the Lumipulse G β-amyloid ratio (1-42/1-40) had the presence of amyloid plaques by PET scan and 84% of individuals with negative results had amyloid PET scans. negative. .
The risks associated with the Lumipulse G β-amyloid Ratio (1-42/1-40) test are primarily the possibility of false positives and false negatives. False positive results, together with other clinical information, could lead to inappropriate diagnosis and unnecessary treatment of Alzheimer’s disease.
This could lead to psychological distress, a delay in receiving a correct diagnosis as well as expense and the risk of side effects from unnecessary treatment. False negative test results could lead to unnecessary additional diagnostic testing and a potential delay in effective treatment. It is important to note that the Lumipulse G β-amyloid Ratio (1-42/1-40) is not a standalone test and other clinical evaluations or additional tests should be used to determine treatment options.
The FDA reviewed the device via the de novo the premarket review pathway, a regulatory pathway for low-to-moderate risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use can go through the FDA’s 510(k) premarket process, through which devices can obtain marketing authorization. market by demonstrating substantial equivalence with a predicate device.
The Lumipulse G β-amyloid Ratio (1-42/1-40) has been granted Revolutionary device designation, a process designed to accelerate the development and review of devices that can provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The FDA has cleared Lumipulse G ß-Amyloid Ratio (1-42/1-40) to Fujirebio Diagnostics, Inc.