FDA approval for first in vitro diagnostic for early Alzheimer’s detection
pharmafile | May 5, 2022 | News story | Business Services |
The US FDA has approved the first in vitro diagnostic to aid in the early detection of Alzheimer’s disease (AD). The Lumipulse G β-Amyloid Ratio (1-42/1-40) test, from Fujirebio Diagnostics, detects amyloid plaques associated with AD in adults aged 55 or older.
The test has been approved for adults who are under investigation for AD, and other causes of cognitive decline. The FDA shared that the test minimises radiation risks to patients who would otherwise need to be tested with positron emission tomography (PET) scans.
According to statistics from the CDC, in 2020, as many as 5.8 million Americans were living with Alzheimer’s, which is the most common type of dementia. The number of people living with Alzheimer’s is projected to nearly triple to 14 million by the year 2060.
“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, MD, JD, director of the FDA’s Centre 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.”
The test has also received breakthrough device designation, meaning it was able to get through an expedited review process for products with unmet need.
“There is an unmet need for a reliable and safe test that can accurately identify patients with amyloid plaques consistent with Alzheimer’s disease,” the FDA shared 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 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.”
Ana Ovey
