The U.S. Food and Drug Administration (FDA) approved the first blood test to detect Alzheimer’s disease in what federal officials called an “important step” toward diagnosing and treating the disease earlier.
Developed by Fujirebio Diagnostics, the test analyzes the ratio of two proteins in a patient’s blood, a measurement that correlates with the presence of amyloid plaques in the brain.
These plaques are a hallmark of Alzheimer’s and previously required either costly positron emission tomography (PET) scans, or invasive spinal fluid analysis for confirmation.
The newly approved test can be used in clinics for patients showing signs of cognitive decline. The results are intended to be interpreted alongside other clinical assessments.
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Why It Matters
The approval could accelerate the diagnosis process for a disease that impacts more than 6 million Americans and is expected to affect twice as many by 2050.
Early diagnosis is crucial for patients to begin treatment with existing therapies that, while not curative, have been shown to slow cognitive decline.
“Alzheimer’s disease impacts too many people—more than breast cancer and prostate cancer combined,” said FDA Commissioner Marty Makary, in the agency’s press release.
Diana Dickson, vice president of clinical and regulatory sciences at Fujirebio Diagnostics, noted the “millions” of people impacted by Alzheimer’s, in addition to patients.
“Millions of patients, family members and caregivers are impacted by this terrible disease and, unfortunately, low-invasive, accessible and affordable diagnostic tools have not been readily available,” Dickson told Newsweek in an email.
“With this FDA clearance, this test becomes available to physicians through any CLIA [Clinical Laboratory Improvement Amendments] laboratory, which enables access to plasma testing.”
What To Know
The test is meant for use in people already showing signs of cognitive impairment. It should be used as part of a broader diagnostic work-up that includes clinical evaluation and possibly additional imaging.
The approval comes as two Alzheimer’s drugs—lecanemab and donanemab—are already authorized by the FDA. Both are antibody therapies that target amyloid plaques and are believed to be more effective when administered earlier in the disease’s progression.
Clinical studies found that the blood test’s accuracy was comparable to PET imaging and spinal fluid testing.
What People Are Saying
Michelle Tarver, of the FDA’s Center for Devices and Radiological Health, said: “Today’s clearance is an important step for Alzheimer’s diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease.”
Makary said: “Knowing that 10% of people aged 65 and older have Alzheimer’s and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.”
Dickson said the test is the culmination of more than 30 years of commitment by Fujirebio in the fight against Alzheimer’s.
“The battle is not nearly over,” she continued, “There is much work to be done, not only with this test, but in the development of other novel biomarkers for use in other pathologies and in other neurodegenerative disease.
“We continue to be committed to these efforts and are immensely grateful for the partnerships with the pharmaceutical, research and patient communities that have made and continue to make these advances possible.”
What Happens Next
The blood test is now authorized for use in clinical practice, but adoption will depend on further integration into care pathways, insurance coverage decisions and physician familiarity.
Dickson said Fujirebio is working to create packaging and inserts to send out their first shipments. The Pennsylvania-headquartered company is finding partners to make sure the clinical data drawn from the tests can be published and discussed within the clinical community.
“Finally, we are engaged with various patient advocacy groups and medical specialties to ensure that the public is aware of the test, how it should and should not be used and how results are best interpreted,” Dickson said.
