Company Announcements

Simoa p-Tau 217 Assay Enables Largest Population-Based Assessment (11,000+ Samples) Revealing Striking Age-Related Increase and Broad Treatment Eligibility

BILLERICA, Mass.--(BUSINESS WIRE)--Dec. 22, 2025-- Quanterix Corporation(NASDAQ: QTRX), a company transforming healthcare by accelerating biomarker breakthroughs from discovery to diagnostics, today announced publication of a landmark study in the prestigious journal Nature. The study, which utilized Quanterix’s ultra-sensitive Simoa p-Tau 217 (phosphorylated tau at threonine 217) research assay, is the largest population-based assessment of Alzheimer’s Disease Neuropathological Changes (ADNC) to date, providing crucial, scalable data to redefine disease prevalence.

The research, conducted on a Norwegian population-based cohort of over 11,000 individuals aged 58 and above, addresses a long-standing challenge in epidemiology: obtaining accurate ADNC prevalence data from a representative general population rather than smaller, clinic-based samples. The study found that prevalence of ADNC rises sharply from 10% in individuals aged 58-69.9 years to 64.9% in those over 90. Furthermore, the findings suggest a higher prevalence of AD dementia in older individuals than previously estimated and enable more confident identification of asymptomatic individuals with ADNC who may benefit from early intervention or clinical trial participation.

"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 Nicholas Ashton, Ph.D., Senior Author of the study and Senior Director at Banner Health, Fluid Biomarker Program. "This study, encompassing over 11,000 samples, fundamentally changes that landscape. The ultra-sensitive plasma p-Tau 217 assay, which was essential for generating these robust data, allowed us to present more representative prevalence estimates than ever before. 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."

The ability to accurately measure p-Tau 217 in plasma from such a large cohort was critical for the study’s robust conclusions. Within the population aged 70 and above, the study confirmed that 30.4% exhibited ADNC. This detailed stratification revealed that 11.4% had preclinical AD, 10.8% had prodromal AD, and 7.4% had AD dementia. Beyond establishing prevalence, the study allowed researchers to make firm associations between sex, APOE genotype, and education level on the development of AD pathology. The study utilized a validated commercial p-Tau 217 kit (ALZpath p-Tau-217 Advantage PLUS) on the fully automated HD-X analyzer to ensure the robustness and generalizability of the findings.

"The sheer scale of this research underscores the indispensable role of highly sensitive biomarker detection in advancing public health understanding," said Masoud Toloue, CEO at Quanterix. "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."

About Quanterix

Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. Its proprietary Simoa® technology delivers industry-leading sensitivity, allowing researchers to detect and quantify biomarkers in blood and other fluids at concentrations far below traditional limits. With approximately 6,000 peer-reviewed publications, Quanterix has been a trusted partner to the scientific community for nearly two decades. In 2025, Quanterix acquired Akoya Biosciences, The Spatial Biology Company®, adding multiplexed tissue imaging with single-cell resolution to its portfolio and 1,396 installed instruments. Together, the combined company offers a uniquely integrated platform that connects biology across blood and tissue—advancing precision medicine from discovery to diagnostics. Learn more at www.quanterix.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release are based on Quanterix’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause Quanterix’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Quanterix’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein. Except as required by law, Quanterix assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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Study Media Contact:
Nicholas Ashton, Ph.D.
Senior Director, Banner Health
Fluid Biomarkers Program
nicholas.ashton@bannerhealth.com

Quanterix Media Contact:
media@quanterix.com

Investor Relations Contact:
Joshua Young
(508) 846-3327 - mobile
jyoung@quanterix.com    

Source: Quanterix Corporation