Quanterix Launches High Accuracy p-Tau 217 Blood Biomarker Test to Aid Physician Diagnosis of Alzheimer’s Disease

New test elevates the performance standard for blood biomarker tests intended for detecting amyloid pathology in individuals with cognitive impairment

Lucent Diagnostics, a diagnostics brand of Quanterix Corporation (NASDAQ: QTRX), today announced expansion of its LucentAD product line with the addition of a high accuracy p-Tau 217 blood test for Alzheimer’s disease – LucentAD p-Tau 217. This lab developed test marks a major advance in the performance of scalable immunoassay-based blood biomarker tests intended for assessing amyloid pathology in individuals with memory complaints.

p-Tau 217 has emerged as a top performing biomarker for Alzheimer’s pathology, enabling clinical sensitivity and specificity in blood. Traditional methods include positron emission tomography (PET) or lumbar puncture for cerebrospinal fluid (CSF) biomarkers, which are expensive, invasive, and lack wide availability. The recent approval of new therapies has highlighted an urgent need for improved diagnostic methods. Highly sensitive and specific blood-based biomarker tests have the potential to speed diagnosis and expand access to treatments for millions of individuals with early Alzheimer’s disease.

LucentAD p-Tau 217 leverages the combination of Quanterix’s ultra-sensitive Simoa® technology and J&J Innovative Medicine’s extensively studied p-Tau 217 antibodies to provide high accuracy with a simplified workflow. Samples can be shipped unfrozen to the Lucent laboratory in packaging provided by Lucent, streamlining the testing process for providers. Training and clinical validation were performed in a combined cohort of over 500 subjects with a range of cognitive status, including subjective cognitive decline, mild cognitive impairment, and early AD. The validation compared the test output to amyloid status determined by CSF biomarker testing. The LucentAD p-Tau 217 test achieved an overall accuracy exceeding 90%, which meets the stringent requirements set forth in the most recent NIA-AA Revised Criteria for Diagnosis and Staging of Alzheimer's Disease. Furthermore, the NIA-AA criteria identify p-Tau 217 as the only plasma biomarker appropriate for accurately diagnosing amyloid pathology.

“The LucentAD p-Tau 217 test provides industry leading performance combined with a simplified workflow for the provider,” said Masoud Toloue, CEO of Quanterix. “The launch of LucentAD p-Tau 217 is an important milestone in our efforts to build broad-based non-invasive testing for amyloid pathology. We believe that Simoa technology offers the world's only full range scalable clinical solution, overcoming the complexities and limitations of less sensitive single-plexed analog immunoassay platforms that struggle to measure this important biomarker. We will make this test available worldwide to all, in our pursuit of improving access to life changing diagnostics and treatments for the millions of individuals and their families living with Alzheimer’s disease.”

“LucentAD p-Tau 217 has the potential to dramatically change the clinical workflow for diagnosing and treating Alzheimer’s patients. High accuracy blood biomarker tests can reduce the reliance on PET and CSF testing availability and simplify the process of determining the presence of AD pathophysiology,” said Tharick Pascoal MD, PhD (neurologist and Associate Professor of Neurology and Psychiatry at the University of Pittsburgh School of Medicine). “These advances will provide significant benefits to patients, providers, and health systems as new therapies become available.”

The LucentAD product line consists of a menu of laboratory developed tests run under CLIA and focused on applications supporting Alzheimer’s diagnosis and treatment. Lucent Diagnostics will announce additional tests aimed at improving the diagnosis and management of Alzheimer’s and other neurological disorders. The LucentAD test is available through a healthcare provider’s order.

To learn more about Lucent Diagnostics, visit: https://www.lucentdiagnostics.com/

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

Disclaimer

The LucentAD test was developed and validated by Quanterix Corporation (CLIA# 22D1053083) in a manner consistent with CLIA requirements. The test has not been cleared or approved by the U.S. Food and Drug Administration.

The Lucent test measures tau protein phosphorylated at threonine 217. Circulating levels of p-Tau 217 have been shown to be a marker of Alzheimer’s Disease (AD) pathology. The test results are intended as an aid in the diagnostic evaluation of AD, to be used in adults presenting with cognitive impairment who are being evaluated for AD. LucentAD test results must be interpreted in conjunction with other diagnostic tools. This test is not intended as a standalone screening or diagnostic assay.

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.

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 2,000 peer-reviewed journals. Find additional information about the Billerica, Massachusetts-based company at https://www.quanterix.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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