Alzheimer’s blood test could hit the market in early 2024, researchers say
Could a simple blood test detect Alzheimer’s disease years before symptoms appear?
New research from Resonant, a Utah biotech company that develops diagnostic tests for neurodegenerative diseases, suggests it may be possible.
Researchers said its new test achieved 100% accuracy in identifying patients with Alzheimer's disease and individuals with mild cognitive impairment (MCI) who went on to develop Alzheimer's disease within five years.
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In the study, a total of 50 blood plasma samples were tested. These included 25 older control individuals, 13 patients who had been diagnosed with Alzheimer's, six patients with mild cognitive impairment who later developed Alzheimer's, and six MCI patients who did not develop Alzheimer's.
The findings were published in Frontiers in Neurology on Oct. 31.
The blood test works by detecting the presence of DNA released from the brain’s neurons, or nerve cells, when they die, according to lead researcher Chad Pollard, a doctorate student and research assistant at Brigham Young University.
"All cells, to some degree, release fragments of DNA called cell-free DNA (cfDNA) into their environment," Pollard, who is also a co-founder of Resonant, told Fox News Digital in an email.
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"Under normal, healthy conditions, cfDNA from neurons is undetectable in blood circulation, but during neurodegeneration, the amount of cfDNA that is released from these cells significantly increases and can be detected in the blood."
The presence of neuron cfDNA in the blood indicates neurodegeneration, Pollard added.
Beyond Alzheimer’s disease, the researchers are also actively working to apply this technology to other neurodegenerative diseases, including Parkinson’s disease and amyotrophic lateral sclerosis (ALS, also called Lou Gehrig's disease), noted Pollard.
Pollard pointed out one limitation of the study.
"While the majority of patients with mild cognitive impairment who did not develop Alzheimer’s disease within five years displayed low levels of neuron cfDNA in the blood, some displayed elevated levels," he said.
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"Due to limitations of the dataset, the researchers were not able to obtain more information about these patients to determine whether this minority remained cognitively stable or eventually developed Alzheimer’s disease."
The team is actively working to improve the specificity and predictive power of the test, Pollard said.
Joseph Antoun, M.D., PhD, a longevity expert and CEO of the nutrition tech company Prolon in Los Angeles, was not involved in the study but offered his input on the findings.
"Though the sample size for the study is relatively low, with only 50 participants, this method of measuring DNA methylation shows interesting potential," Antoun told Fox News Digital.
"I would love to see it performed at a larger scale, with a bigger population size, and with other neurodegenerative disorders," he said.
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In future studies, Antoun said he would recommend ensuring that the results aren’t being polluted by a different preexisting condition, as Alzheimer’s patients tend to have other comorbidities such as dementia, depression, obesity and cardiovascular disease.
"Additionally, I would also be curious to look at the cost of a blood test like this, particularly one that promises such exciting developments in the medical field," he said.
"Overall, I’m interested to see more expansive, specific research to further support this data."
Resonant expects to launch its Alzheimer’s test in the first quarter of 2024.
There are a few blood tests that are currently available to health care providers to help with diagnosis, but they are not yet approved by the U.S. Food and Drug Administration (FDA), according to the Alzheimer’s Association.
"At this time, it is recommended that blood tests only be used by specialty care doctors who are seeing patients with memory complaints," states the association on its website. "They are not recommended for individuals who do not have any cognitive or memory symptoms."
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More than six million Americans are living with Alzheimer's, which is the most common form of dementia, according to the Alzheimer’s Association.
That number is projected to reach nearly 13 million by 2050.
Diagnosis has traditionally occurred after symptoms of cognitive decline appear — but identifying the disease sooner could enable patients to access preventive drugs and dramatically slow progression, according to Resonant researchers.
"These data demonstrate significant potential for this technology's use as a clinically actionable predictor of neurodegeneration, which could allow for pre-symptomatic interventions," said Timothy Jenkins, PhD, co-founder of Resonant, in a press release.
"We believe that such early identification is the key to improving outcomes for patients with neurodegenerative disease."
People can view the company’s peer-reviewed research or join the waitlist for the test at its website, www.resonantdx.com.