Quanterix Announces First Collaborations with Five Health Networks to Aid the Diagnosis and Clinical Management of Individuals with Alzheimer’s Disease

AdventHealth, Mass General Brigham, Mayo Clinic, MUSC, and UPMC will leverage Quanterix technology and assays to streamline care for Alzheimer’s patients

Quanterix Corporation (NASDAQ: QTRX), a leading provider of ultra-sensitive research products and high-definition diagnostics, today announced its first collaborations with health systems in pursuit of their shared goal to improve and simplify Alzheimer’s disease (AD) diagnosis. These relationships further the company’s goal to build the global infrastructure necessary for AD testing by expanding clinical access to Quanterix’s leading blood biomarker assays.

Collectively AdventHealth, Mass General Brigham, Mayo Clinic, South Carolina Alzheimer's Disease Research Center (SC-ADRC) at the Medical University of South Carolina, and UPMC represent 140+ hospitals across 18 states, caring for approximately 21 million patients in their hospital networks. This reach will provide greater access to patients for high-accuracy, non-invasive AD testing. Quanterix can enable health systems to access Alzheimer’s blood biomarker tests through a variety of models, including sample processing through Lucent Diagnostics, Quanterix’s diagnostic testing brand, or by installing Simoa technology in-house to develop and validate their own Laboratory Developed Tests (LDTs).

Blood-based biomarker testing offers Alzheimer’s patients a non-invasive method and greater access to AD testing overall. Traditional AD diagnosis has relied on combination of symptom presentation, brain imaging, and the detection of CSF biomarkers for AD. This approach is not only burdensome and invasive for patients, but also costly, making them unsuitable for most primary and secondary care settings¹. This inaccessibility has left 50-70% of symptomatic AD patients without a correct and timely diagnosis, impacting quality of life, medical autonomy, and general wellbeing¹. With 15 million Americans predicted to be affected by Alzheimer’s by 2060,² high-accuracy, easily accessible blood testing will play a critical role in early detection and treatment of Alzheimer’s. Quanterix’s Simoa p-Tau 217 assays provide high accuracy, consistent with the recommendations in the recent NIA-AA criteria for Alzheimer’s diagnosis³, stating that p-Tau 217 is the only plasma biomarker appropriate for Alzheimer’s diagnosis.

“New resources available to aid in diagnosis and treatment of Alzheimer's disease have contributed to a more optimistic environment for AD patient care,” said Kirk Erickson, PhD, director of translational neuroscience at the AdventHealth Neuroscience Institute. “With simplified, affordable, non-invasive testing methods, physicians can proactively evaluate and monitor patients with memory concerns. The availability of blood-based biomarker testing to the AdventHealth network has the potential to help a wide population concerned about mild cognitive impairment and aid physicians in their diagnosis.”

"As we see how well blood measures of p-Tau 217 perform," said Dr. Brad Dickerson, MD of Mass General Neurology and Harvard Medical School, "it is exciting to plan for this new tool in our workflow to make an early, accurate diagnosis if a patient is suspected of having Alzheimer's disease."

“In our pursuit to build the global testing infrastructure for Alzheimer’s disease, Quanterix is pleased to work with several health systems whose combined networks treat millions of patients,” said Masoud Toloue, CEO of Quanterix. “There is a critical need for easily accessible, time- and cost-effective diagnostic tools for Alzheimer’s. By working with these leading hospitals, we are taking an important step just as disease modifying therapies become available to patients suffering from this disease.

Quanterix’s commitment to establishing the industry standard for accuracy continues to position the company as a critical partner for AD testing. Beyond these five health systems, Quanterix is initiating partnerships with reference laboratories and hospitals globally to enable patients with cognitive symptoms consistent with Alzheimer’s disease to be tested.

For more information about Quanterix’s work in neurology, visit: https://www.quanterix.com/therapeutic-areas/neurology/.

About Quanterix

From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. The Company’s Simoa^® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Limit of Quantification (LoQ) of conventional analog methods. Its industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology and infectious disease. Quanterix has been a trusted partner of the scientific community for nearly two decades, powering research published in more than 2,700 peer-reviewed journals. Find additional information about the Billerica, Massachusetts-based company at https://www.quanterix.com or follow us on Twitter and LinkedIn.

About Lucent Diagnostics

Committed to transforming the landscape of Alzheimer’s Disease (AD) diagnostic testing, Lucent Diagnostics, a Quanterix brand, is revolutionizing AD patient care by providing accurate, reliable, and actionable diagnostic information to healthcare professionals and patients alike. Lucent Diagnostics harnesses Quanterix’s ultrasensitive Simoa^® technology—the groundbreaking biomarker detection technology that delivers the gold standard for earlier biomarker detection in blood, serum or plasma— to power its mission of addressing the critical need for advanced diagnostic tools that can measure biomarkers associated with neurodegenerative diseases. The LucentAD test, powered by Simoa^®, is available to healthcare providers as an aid in conjunction with other diagnostic tools, provides clinicians with a simplified process to quickly assess the likelihood of a patient having amyloid pathology consistent with AD, allowing for early or preventative AD treatment. The LucentAD product line currently measures p-Tau 181 and p-Tau 217 in plasma, two of the top performing biomarkers for AD. Find additional information about the Billerica, Massachusetts-based company at https://www.lucentdiagnostics.com/ or follow us on Twitter and LinkedIn.

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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¹ Hansson O, Edelmayer RM, Boxer AL, et al. The Alzheimer’s Association appropriate use recommendations for blood biomarkers in Alzheimer’s disease. Alzheimers Dement. 2022;18(12):2669-2686. doi:10.1002/alz.12756

² Brookmeyer R, Abdalla N, Kawas CH, Corrada MM. Forecasting the prevalence of preclinical and clinical Alzheimer’s disease in the United States. Alzheimers Dement. 2018;14(2):121-129. doi:10.1016/j.jalz.2017.10.009

³ Draft NIA-AA Revised Criteria for Diagnosis and Staging of Alzheimer's Disease, published October 2023.

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