Press Release
☷FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer s Disease
Food and Drug Administration ( By Press Release office)
May 04,2022
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For Immediate Release: May 04 , 2022 The U . S . Food and Drug Administration today permitted marketing for the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease . The Lumipulse G β - Amyloid Ratio ( 1 - 42/1 - 40 ) test is intended to be used in adult patients , aged 55 years and older , presenting with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline . “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 with the possibility of an Alzheimer’s disease diagnosis , ” said Jeff Shuren , M . D . , J . D . , director of the FDA’s Center for Devices and Radiological Health . “With the Lumipulse test , there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status , without the radiation risk , to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease . ” According to the National Institutes of Health , more than six million Americans , most age 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 carry out the simplest tasks . In most people with Alzheimer’s disease , clinical symptoms first appear later in life . Alzheimer’s disease is progressive , meaning 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 . While amyloid plaques can occur in other diseases , being able to detect the presence of plaque , along with other evaluations , helps the doctor determine the probable cause of the patient’s symptoms and findings . Prior to today’s authorization , doctors used positron emission tomography ( PET ) scans , a potentially costly and cumbersome option , to detect/visualize amyloid plaques in a patient’s brain , often years before clinical symptom onset , to aid in diagnosing Alzheimer’s disease . The Lumipulse test is intended to measure the ratio of β - amyloid 1 - 42 and β - amyloid 1 - 40 ( specific proteins that can accumulate and form plaques ) concentrations found in human cerebral spinal fluid ( CSF ) , which can help physicians determine whether a patient is likely to have amyloid plaques , a hallmark sign of Alzheimer’s disease . Results must be interpreted in conjunction with other patient clinical information . A positive Lumipulse G β - amyloid Ratio ( 1 - 42/1 - 40 ) test result is consistent with the presence of amyloid plaques , similar to what would be seen in a PET scan . A negative result is consistent with a negative amyloid PET scan result . A negative test result reduces the likelihood that a patient’s cognitive impairment is due to Alzheimer’s disease , enabling physicians to pursue other causes of cognitive decline and dementia . The test is not intended as a screening or stand - alone diagnostic assay . There is also the possibility that a positive test result could be seen in patients with other types of neurologic conditions , as well as in older cognitively healthy people , which underscores the importance of using this test in conjunction with other clinical evaluations . 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 . The samples were tested by the Lumipulse G β - amyloid Ratio ( 1 - 42/1 - 40 ) and compared with amyloid PET scan results . In this clinical study , 97% of individuals with Lumipulse G β - amyloid Ratio ( 1 - 42/1 - 40 ) positive results had the presence of amyloid plaques by PET scan and 84% of individuals with negative results had a negative amyloid PET scan . The risks associated with the Lumipulse G β - amyloid Ratio ( 1 - 42/1 - 40 ) test are mainly the possibility of false positive and false negative test results . False positive results , in conjunction with other clinical information , could lead to an inappropriate diagnosis of , and unnecessary treatment for , Alzheimer’s disease . This could lead to psychological distress , delay in receiving a correct diagnosis as well as expense and the risk for side effects from unnecessary treatment . False negative test results could result in additional unnecessary diagnostic tests and potential delay in effective treatment . Importantly , the Lumipulse G β - amyloid Ratio ( 1 - 42/1 - 40 ) is not a stand - alone test and other clinical evaluations or additional tests should be used for determining treatment options . The FDA reviewed the device through the De Novo 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 may go through FDA’s 510 ( k ) premarket process , whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device . The Lumipulse G β - amyloid Ratio ( 1 - 42/1 - 40 ) was granted Breakthrough Device designation , a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life - threatening or irreversibly debilitating diseases or conditions . The FDA permitted marketing of the Lumipulse G ß - Amyloid Ratio ( 1 - 42/1 - 40 ) to Fujirebio Diagnostics , Inc .
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