Mark it as a day to remember. Today the FDA authorized the first in vitro diagnostic test for Alzheimer’s disease, enabling diagnosis of the dreaded disease years earlier than current clinical tests. Fujirebio Diagnostics Inc.’s Lumipulse G β-Amyloid Ratio (1-42/1-40) measures specific proteins in cerebral spinal fluid to provide rapid assessment of the risk of amyloid plaques, an indicator of the disease that may develop decades before cognitive impairment occurs.

Clinical tests that assess cognitive function do not accurately identify Alzheimer’s disease (AD) in more than half of early cases. Currently, early diagnosis relies on positron emission tomography (PET) brain imaging that can detect amyloid plaques, but the specialized equipment required is not widely available and the cost is prohibitive for many patients as it is often not covered by insurance. The Lumipulse test is consistent with PET scan results.

"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 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." 

Early detection offers patients the opportunity to make lifestyle changes that can reduce the risk of AD and in some cases improve symptoms. A National Institutes of Health study with 3,000 participants demonstrated that those who adhered to at least four of five healthy habits experienced a 60% reduction in risk of developing AD. The habits included physical activity, not smoking, light-to-moderate alcohol consumption, a high-quality Mediterranean-style diet and cognitive activities.

“FDA authorization of the Lumipulse G β-Amyloid Ratio (1-42/1-40) test and the upcoming U.S. launch are important milestones in the campaign to transform AD into a manageable disease,” says Monte Wiltse, president and CEO at Fujirebio Diagnostics Inc. “Patients, physicians and families now have a valuable new tool to help identify those individuals whose early symptoms may be indicative of AD, providing the opportunity to adopt lifestyle changes and potentially to access new therapies aimed at slowing or stopping disease progression. FDA authorization of this first IVD biomarker test reflects our ongoing commitment to working with the healthcare community and AD advocates to achieve significant progress against this devastating disease.”

Individuals diagnosed with amyloid plaques prior to AD symptom onset may also choose to participate in clinical trials of pharmacotherapies and other interventions to slow or potentially reverse disease progression.

“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,” said the FDA in announcing the decision.