The FDA said it has issued its first official green light for a blood test to help diagnose Alzheimer’s disease, adding that it can help reduce the need for invasive samples or expensive PET scans.
The Lumipulse G test, developed by Fujirebio Diagnostics, measures the ratio between two proteins in the bloodstream—pTau-217 and beta amyloid 1-42—and ties its findings to the likelihood of finding amyloid plaque buildups in the brain.
Other companies, such as Labcorp, Quest Diagnostics and others, have offered blood-based tests for a variety of biomarkers linked to the neurodegenerative disease, but as lab-developed tests—including for beta amyloid and tau proteins as well as for neurofilament light chain and other evidence of brain tissue damage.
The FDA said Fujirebio’s in vitro kit is the first to receive a 510(k) clearance. A previous version of the Lumipulse G test obtained a de novo clearance in May 2022 for measuring two beta amyloid proteins in samples of cerebrospinal fluid taken via a spinal tap.
“Nearly 7 million Americans are living with Alzheimer's disease and this number is projected to rise to nearly 13 million,” Michelle Tarver, M.D., Ph.D., director of the agency’s Center for Devices and Radiological Health, said in a statement. “Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease.”
A clinical study of the Lumipulse blood test evaluated nearly 500 plasma samples from adults who showed signs of cognitive impairment. Its results were then compared to CSF tests or PET scans; 91.7% of people with positive blood test results were confirmed as correct, as were 97.3% of the negative findings. The agency said fewer than 20% of patients received an indeterminate result.
Fujirebio’s test is intended for patients ages 55 and older who have already shown signs and symptoms of cognitive decline. Used alongside additional clinical information, it can aid in identifying people with Alzheimer’s from those with other types of dementia.
"The ability to diagnose Alzheimer's earlier with a simple blood test, like we do for cholesterol, is a game changer, allowing more patients to receive treatment options that have the potential to significantly slow or even prevent the disease," Howard Fillit, co-founder and chief science officer of the Alzheimer's Drug Discovery Foundation, said in a statement. "This is a clear example of the new era of Alzheimer's research where innovation, science and technology come together to develop more accessible, affordable and scalable tools that will pave the way for additional regulatory approvals of diagnostic tools."
Last December, Fujirebio signed a deal with Japanese drugmaker Eisai to jointly study and promote blood-based biomarkers for neurodegenerative diseases, following their previous work together in cerebrospinal fluid tests.
Meanwhile, Eisai, along with its partner Biogen, recently laid out a plan to turn their Alzheimer’s therapy Leqembi into a bona fide blockbuster drug by the 2027 fiscal year. The lack of access to earlier diagnostics has held back Leqembi’s commercialization since its launch in 2023.