Alzheimer’s disease blood test developer Quanterix put forward new clinical data from its Simoa assay, which it described as the largest population-based assessment of the condition’s neuropathological changes to date.
Published in the journal Nature, the research showed that the company’s ultrasensitive test for the phosphorylated tau-217 biomarker could help identify potentially higher-than-expected rates of Alzheimer’s-related dementia among older individuals—a number that rises sharply from 10% among people between ages 58 and 70 to nearly 65% in those over 90.
The company said the results also suggest its blood test could help find people at risk before symptoms begin to show, who could then seek early treatment or enroll in a clinical trial.
“For decades, accurately mapping the true prevalence of Alzheimer’s disease pathology in the general population was hindered because we lacked scalable, accurate blood-based tools,” said the study’s senior author, Nicholas Ashton, Ph.D., senior director of Banner Health’s fluid biomarker program.
“Critically, our findings—which indicate that 10% of the 70+ population meet current treatment eligibility criteria—provide vital, actionable data for public health authorities and the pharmaceutical industry as they plan for future care and access to disease-modifying therapies,” Ashton said in a statement.
The researchers analyzed more than 11,400 samples collected through the Norwegian Trøndelag Health trial, known as the Hunt study, which has been ongoing for more than 40 years.
Plasma pTau-217 concentrations increased with age. The study also found that about a third of the 70-plus population was affected—with 10% having preclinical Alzheimer's, 10.4% having prodromal disease and 9.8% having related dementia.
Quanterix’s blood test was also used to rule out Alzheimer’s related changes in some cases, including in 41% of people with mild cognitive impairment and 19% of those with dementia.
“The sheer scale of this research underscores the indispensable role of highly sensitive biomarker detection in advancing public health understanding,” said Quanterix CEO Masoud Toloue, Ph.D. “Our Simoa technology continues to be the enabling platform for generating population-level epidemiological insights that are necessary for planning drug development, optimizing clinical trials, and preparing healthcare systems for the future of Alzheimer’s treatment.”
The pTau-217 research assay taps into a biomarker kit from developer ALZpath, which recently licensed the antibody to Siemens Healthineers for use on its Atellica immunoassay platforms.
The FDA cleared its first blood test for use in diagnosing Alzheimer’s earlier this year, with Fujirebio’s Lumipulse G that checks for pTau-217 and beta amyloid. Roche later secured a green light for its pTau-181 blood test in October.