First in vitro diagnostic for early Alzheimer’s detection gets FDA blessing

Regulatory NewsRegulatory News | 04 May 2022 |  By 

Source: Fujirebio

The US Food and Drug Administration (FDA) has authorized the first in vitro diagnostic to help diagnose early Alzheimer’s disease. The agency said the test minimizes radiation risks to patients who otherwise would need to be tested with positron emission tomography (PET) scans.
On 4 May, FDA announced it has given the green light to Fujirebio Diagnostics’ de novo application for its Lumipulse G β-Amyloid Ratio (1-42/1-40) test, which is intended for patients ages 55 years and older who have shown cognitive impairment. The test also received breakthrough device designation, meaning it was able to get through an expedited review process for products with unmet need.
“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, director of the Center for Devices and Radiological Health (CDRH). “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.”
The Lumipulse test measures the ratio of the proteins β-amyloid 1-42 and β-amyloid 1-40 cerebral spinal fluid (CSF) that may be an indication of amyloid plaques in the brain that are linked to Alzheimer’s.

FDA cautioned that the test is only meant to be a used in conjunction with other clinical information to confirm if a patient has Alzheimer’s disease. The agency also noted that the test carries a risks for false positive results that could lead to unnecessary treatments and stress on patients, as well as false negative results that could delay patient treatment.
“There is an unmet need for a reliable and safe test that can accurately identify patients with amyloid plaques consistent with Alzheimer’s disease,” FDA said in a statement. “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.”
FDA based its decision to authorize the test based on a clinical study of 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative sample bank. Samples were tested using the Lumipulse G β-amyloid Ratio (1-42/1-40) and compared to amyloid PET scan results.
According to FDA, 97% of individuals tested with positive Lumipulse G β-amyloid Ratio (1-42/1-40) positive also had amyloid plaques by PET scan and 84% of individuals with negative results had a negative amyloid PET scan.
FDA’s decision to authorize the Lumipulse test comes almost one year after the agency’s controversial approval of Biogen’s Alzheimer’s disease therapy Aduhelm (aducanumab) based on a reduction in brain amyloid plaque. (RELATED: FDA approves aducanumab for use in Alzheimer’s disease, Regulatory Focus 7 June 2021)
Aducanumab was approved based on the results from two Phase 3 clinical trials of patients with early Alzheimer’s, though both trials were stopped in March 2019 due to apparent futility by a data safety monitoring board.
Independent experts on FDA’s Peripheral and Central Nervous System (PCNS) Drugs advisory committee voted against the drug’s approval on the grounds that it had not proven efficacy.
At the time, Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research (CDER) said the agency decided to grant the drug accelerated approval based on the surrogate endpoint due to the potential that a “reduction in amyloid plaque will result in a reduction in clinical decline.”


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