Quanterix Presents Data Demonstrating Successful Multi-Marker Approach for Alzheimer’s Disease Detection that is More Effective than Standalone Plasma p-Tau 217

Rhea-AI Summary

Quanterix (NASDAQ: QTRX) presented new data at the Alzheimer's Association International Conference (AAIC) demonstrating a novel multi-marker approach for Alzheimer's disease (AD) detection. This approach significantly reduces the intermediate zone of a two-cutoff p-Tau 217 test while maintaining high accuracy above 90%. The multi-marker method combines p-Tau 217 with other AD-associated plasma biomarkers, including amyloid β 42, amyloid β 40, GFAP, and NfL, in an algorithm that provides a single risk score.

Key findings include:

• Reduced intermediate zone from 31.2% to 10.5% compared to p-Tau 217 alone
• Accurate amyloid classifications for 151 of 228 previously uncertain results
• Potential to provide diagnostic certainty for more patients

Quanterix plans to launch a multi-marker laboratory developed test later this year through its LucentAD product line.

Positive

• New multi-marker approach reduces uncertain results in Alzheimer's disease detection
• Maintains high accuracy above 90% while reducing intermediate zone 3-fold
• Potential to provide diagnostic certainty for more patients undergoing AD evaluation
• Plans to launch multi-marker laboratory developed test later this year

Negative

• None.

Insights

Medical Research Analyst

Quanterix's presentation at the Alzheimer's Association International Conference (AAIC) marks a significant advancement in Alzheimer's disease (AD) detection. The company's novel multi-marker approach, combining p-Tau 217 with other AD-relevant biomarkers, addresses a critical challenge in AD diagnostics: reducing inconclusive results while maintaining high accuracy.

Key findings include:

• The multi-marker approach reduced the intermediate zone (inconclusive results) from 31.2% to 10.5%, a 3-fold improvement.
• This method provided accurate amyloid classifications for 151 out of 228 previously uncertain results.
• The overall accuracy remained above 90%.

This development is particularly noteworthy as it aligns with recent Alzheimer's Association criteria for plasma p-Tau 217 tests. By reducing inconclusive results, this approach could significantly improve the efficiency of AD diagnostics, potentially leading to earlier and more accurate diagnoses.

The implications of this research extend beyond just improving diagnostic accuracy. It paves the way for more personalized treatment approaches, especially considering that approximately 30% of Alzheimer's patients have non-AD pathologies. This multi-marker strategy could be instrumental in differentiating between AD and other neurodegenerative diseases, important for tailoring appropriate treatments.

Quanterix's plan to launch a multi-marker laboratory developed test later this year through its LucentAD product line signifies a rapid translation of research into clinical practice. This move could potentially accelerate the adoption of blood-based testing for AD in clinical settings, offering a less invasive and more accessible diagnostic tool compared to current methods.

Financial Analyst

Quanterix's (NASDAQ: QTRX) announcement of its multi-marker approach for Alzheimer's disease detection represents a potentially significant market opportunity. The Alzheimer's diagnostics market is projected to grow substantially in the coming years, driven by an aging population and increasing focus on early detection and treatment of neurodegenerative diseases.

Key financial implications include:

• Potential for increased market share: By offering a more accurate and comprehensive testing solution, Quanterix could capture a larger portion of the AD diagnostics market.
• Revenue growth prospects: The planned launch of a multi-marker laboratory developed test later this year could drive near-term revenue growth for the company's LucentAD product line.
• Competitive advantage: This innovative approach could differentiate Quanterix from competitors, potentially leading to premium pricing and higher profit margins.
• Research and development (R&D) investment: The company's continued investment in further studies suggests ongoing R&D expenses, which could impact short-term profitability but potentially lead to long-term gains.

Investors should note that while this development is promising, the translation of scientific advancements into commercial success is not guaranteed. Factors such as regulatory approval, reimbursement policies and market adoption will play important roles in determining the financial impact of this innovation.

Furthermore, the broader context of Quanterix's financial health, including its cash position, burn rate and overall product pipeline, should be considered when evaluating the company's investment potential. The success of this multi-marker approach could potentially catalyze partnerships or collaborations with pharmaceutical companies developing AD treatments, opening up additional revenue streams.

Tech Expert

Quanterix's multi-marker approach for Alzheimer's disease (AD) detection showcases the power of advanced biomarker detection technologies in revolutionizing medical diagnostics. The company's Simoa technology, which underpins this breakthrough, demonstrates the critical role of ultrasensitive detection methods in pushing the boundaries of what's possible in blood-based testing.

Key technological aspects to consider:

• Sensitivity: The digital p-Tau 217 assay, powered by Simoa technology, has shown remarkable sensitivity, providing readable results for all samples tested in over 2,000 cases.
• Multi-marker integration: The ability to combine multiple biomarkers (p-Tau 217, amyloid β 42, amyloid β 40, GFAP and NfL) into a single algorithm showcases advanced data integration and analysis capabilities.
• Scalability: The potential to expand this approach to other neurodegenerative diseases suggests a scalable technological platform.

The development of this multi-marker approach represents a convergence of several cutting-edge technologies, including ultrasensitive biomarker detection, advanced algorithms for data interpretation and possibly machine learning techniques for optimizing the multi-marker algorithm.

From a broader perspective, this advancement aligns with the trend towards precision medicine, where diagnostic tools are becoming increasingly sophisticated and tailored to individual patient profiles. It also highlights the growing importance of blood-based biomarker testing in neurology, potentially reducing the need for more invasive or expensive diagnostic procedures.

As Quanterix moves towards commercializing this technology, key considerations will include the scalability of their production processes, quality control measures for ensuring consistent results across different laboratory settings and the potential for integrating this technology with other diagnostic tools and electronic health record systems.

Quanterix improves on its best-in-class p-Tau 217 standalone test with new multi-marker approach reducing the number of patients receiving uncertain results

BILLERICA, Mass.--(BUSINESS WIRE)-- Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, today presented new data at the Alzheimer’s Association International Conference (AAIC), supporting a novel multi-marker approach to test for Alzheimer’s disease (AD). For the first time, new data show that applying a combination of AD-relevant biomarkers with p-Tau 217 significantly reduces the intermediate zone of a two-cutoff p-Tau 217 test, while preserving high accuracy above 90%.

Recent Alzheimer’s Association criteria for diagnosing Alzheimer’s recommends that plasma p-Tau 217 tests be designed with two cutoffs to confidently differentiate between patients with or without AD pathology. This two-cutoff approach maximizes the accuracy of a p-Tau 217 test but leaves a zone of intermediate risk between the two cutoffs representing inconclusive borderline amyloid status. It is desirable to reduce this intermediate region while preserving a test’s accuracy to reduce the number of patients receiving inconclusive results.

Quanterix investigated whether interrogating intermediate samples with a panel of additional Alzheimer’s-associated plasma biomarkers, including combinations of amyloid β 42, amyloid β 40, GFAP, and NfL, together with p-Tau 217 in an algorithm that provides a single risk score, would improve the amyloid classification of uncertain results compared to a stand-alone p-Tau 217 test. The research found that this multi-marker approach enabled accurate amyloid classifications for 151 of 228 previously uncertain results across a large, high-diversity cohort of symptomatic individuals, reducing the intermediate zone 3-fold from 31.2% to 10.5% compared to p-Tau 217 alone. This finding highlights a potential key benefit of a multi-marker approach to blood-based Alzheimer’s testing, which is to provide diagnostic certainty for a significantly greater number of patients undergoing evaluation for AD.

“Quanterix’s Simoa technology is an exceptionally sensitive platform, which when combined with our digital p-Tau 217 assay, has provided a result for all samples tested,” said Masoud Toloue, CEO of Quanterix. “In over 2,000 samples tested, our LucentAD p-Tau 217 assay has yet to encounter a single result that is unreadable and combines this sensitivity with an overall accuracy above 90%. With these novel multi-marker results, we are leveraging the best of our p-Tau 217 test along with other AD-relevant biomarkers. We believe that a multi-marker approach is the next phase in the evolution of blood-based testing, not only for identifying and staging Alzheimer’s pathology, but also for informing important differential treatment pathways that include non-Alzheimer’s neurodegenerative diseases. The latter is an important consideration given approximately 30% of Alzheimer’s patients have pathologies other than AD.”

Quanterix is currently investing in further studies to evaluate multi-marker testing and expects to launch a multi-marker laboratory developed test later this year through its LucentAD product line. LucentAD consists of a menu of laboratory developed tests run under CLIA and focused on applications supporting Alzheimer’s diagnosis and treatment.

This work is being presented in a virtual poster entitled, “Multi-Marker Approach to Reducing the Intermediate Range of a High Accuracy 2-Cutoff Plasma p-Tau 217 Test for Amyloid Detection,” poster 95706, throughout AAIC. Quanterix will be at AAIC (7/28 – 8/1) at booth #730. Interested parties can schedule time to meet with Quanterix team members onsite using the event website: (https://www.quanterix.com/conferences/alzheimers-association-international-conference-aaic-2024/).

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/.

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 2,900 peer-reviewed journals. Find additional information about the Billerica, Massachusetts-based company at https://www.quanterix.com or follow us on Twitter and LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240729813152/en/

Media:

PAN Communications

Maya Nimnicht

(510) 334-6273

quanterix@pancomm.com

Investor Relations:

Francis Pruell, Quanterix

(508) 789-1725

ir@quanterix.com

Source: Quanterix Corporation

FAQ

What is Quanterix's new approach for Alzheimer's disease detection?

Quanterix has developed a multi-marker approach that combines p-Tau 217 with other Alzheimer's-associated plasma biomarkers (amyloid β 42, amyloid β 40, GFAP, and NfL) in an algorithm to provide a single risk score for Alzheimer's disease detection.

How does the multi-marker approach improve Alzheimer's detection compared to p-Tau 217 alone?

The multi-marker approach reduces the intermediate zone of uncertain results from 31.2% to 10.5% compared to p-Tau 217 alone, while maintaining high accuracy above 90%. It provided accurate amyloid classifications for 151 of 228 previously uncertain results.

When does Quanterix (QTRX) plan to launch its multi-marker test for Alzheimer's?

Quanterix plans to launch a multi-marker laboratory developed test later this year through its LucentAD product line.

What is the potential benefit of Quanterix's multi-marker approach for Alzheimer's testing?

The multi-marker approach has the potential to provide diagnostic certainty for a significantly greater number of patients undergoing evaluation for Alzheimer's disease, reducing the number of inconclusive results.