The Food and Drug Administration (FDA) has granted marketing authorization to Lumipulse G β-Amyloid Ratio (1-42/1-40), an in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer disease.
The Lumipulse G β-Amyloid Ratio (1-42/1-40) test is intended to be used as an aid in adults 55 years of age and older presenting with cognitive impairment who are being evaluated for Alzheimer disease and other causes of cognitive decline. The test measures the ratio of β-Amyloid 1-42 and β-Amyloid 1-40 concentrations found in human cerebral spinal fluid (CSF) to help clinicians determine whether a patient is likely to have amyloid plaques.
The Lumipulse G β-Amyloid Ratio (1-42/1-40) test offers an alternative to the current standard for determining amyloid pathology, amyloid positron emission tomography (PET) brain imaging. The efficacy and safety of the test was compared with amyloid PET scan results in a clinical study that included 292 CSF samples from the Alzheimer Disease Neuroimaging Initiative sample bank. Results showed that 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.
“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 disease,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.
The Lumipulse G β-Amyloid Ratio (1-42/1-40) test carries risks associated with the possibility of false positive and false negative test results. The test is not intended to be used as a screening or stand-alone diagnostic assay.
- FDA permits marketing for new test to improve diagnosis of Alzheimer’s disease. News release. US Food and Drug Administration. Accessed May 4, 2022. https://www.prnewswire.com/news-releases/fda-permits-marketing-for-new-test-to-improve-diagnosis-of-alzheimers-disease-301540093.html
- Fujirebio Diagnostics Lumipulse® G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test receives marketing authorization for the assessment of Alzheimer’s disease. News release. May 5, 2022. https://www.businesswire.com/news/home/20220505005277/en/