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Quanterix’ Simoa® Technology Powers Advances in Alzheimer’s Disease Research Presented at 2021 Clinical Trials on Alzheimer’s Disease (CTAD) Conference
Quanterix Corporation (NASDAQ: QTRX) announced advancements in Alzheimer's disease clinical trials utilizing its ultra-sensitive Simoa® technology. Findings presented at the CTAD conference from November 9-12, 2021, underscored the importance of plasma biomarkers like pTau-181 and pTau-217 in early-stage patient trials, enhancing enrollment efficiency. Biogen and Eli Lilly showcased significant correlations between plasma biomarker reductions and cognitive decline in their studies. Additionally, Simoa's pTau-181 assay received FDA Breakthrough Device Designation, marking a notable achievement for Quanterix.
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Simoa technology enabled advancements in Alzheimer's clinical trials, improving trial design focusing on early-stage patients.
FDA granted Breakthrough Device Designation for Simoa's pTau-181 assay, enhancing its market potential.
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Ultra-sensitive Simoa® technology highlights the important potential of plasma biomarkers to enable drug trials focusing on patients at an earlier stage of disease and to facilitate accelerated and more efficient trial enrollment
BILLERICA, Mass.--(BUSINESS WIRE)--
Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, today announced that its ultra-sensitive Simoa® technology enabled important advances in ongoing clinical trials for the treatment of Alzheimer’s disease. The findings were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference held on November 9-12, 2021.
“Researchers in industry and academia continue to demonstrate the importance of highly sensitive plasma-based biomarker measurements including pTau-181, pTau-217 and pTau-231,” said Kevin Hrusovsky, Chairman and CEO of Quanterix and Founder of Powering Precision Health (PPH). “The assays represent a new frontier in Alzheimer’s disease clinical research, enabling new trial designs focused on patients at earlier stages of disease, and facilitating accelerated and more efficient trial enrollment. We are excited about the emerging role our innovative tools can play in advancing critically important drugs and their potential for ushering in a new field of “neuro diagnostic therapies” that someday may enable treatment before the onset of devastating symptoms such as dementia.”
Biogen Corporation, a global pharmaceutical company, presented data from its Phase 3 EMERGE and ENGAGE studies, which used Quanterix’ Simoa HD-X technology and assays to measure plasma pTau-181. Biogen reported a significant reduction in plasma pTau-181 levels following treatment with ADUHELM™. Importantly, the reduction correlated with reduction in brain amyloid as measured by PET scan, as well as a reduction in cognitive and functional decline. Quanterix recently announced that its Simoa plasma pTau-181 assay has been granted Breakthrough Device Designation from the FDA for use as an aid in Alzheimer’s disease diagnosis.
Eli Lilly and Company presented data from its Phase 2 TRAILBLAZER ALZ study, which employed Quanterix’ HD-X technology and assays to measure plasma pTau-217, using antibodies developed by Lilly. The study demonstrated that a reduction in plasma pTau-217 was a statistically significant predictor of slowing of cognitive decline. Lilly also highlighted the utility of Simoa plasma pTau-181 and pTau-217 assays as tools for screening trial participants, with the potential to improve the speed and reduce the cost of pivotal clinical trials.
Additionally, Dr. Nicholas Ashton, assistant professor at the University of Gothenberg, Sweden, presented data from a prototype Simoa plasma pTau-231 assay. These results highlight the potential role for emerging biomarker measurements in the detection of Alzheimer’s disease pathology even earlier in the disease continuum, when patients are asymptomatic and not yet exhibiting brain pathology in PET imaging studies.
The mission of the CTAD conference is to disseminate new learnings from clinical trials in Alzheimer’s disease and to drive collaborative discussion among the leaders in the field of Alzheimer’s detection and treatment. As highlighted in the presentations throughout the week, Quanterix continues to serve as an instrumental partner with academic research and industry partners, helping to fuel critical advances in neurodegenerative research through the close study of plasma and cerebral spinal fluid neurological biomarkers.
Quanterix is a company that’s digitizing biomarker analysis with the goal of advancing the science of precision health. The company’s digital health solution, Simoa, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the continuum from health to disease. Quanterix’ technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease. The company was established in 2007 and is located in Billerica, Massachusetts. For additional information, please visit https://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’ 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’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Quanterix’ 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.
What advancements did Quanterix report at the CTAD conference regarding Alzheimer's disease trials?
Quanterix reported significant advancements in Alzheimer's disease trials, showcasing the effectiveness of its Simoa technology in facilitating early-stage patient enrollment and biomarker measurements.
What is the significance of the FDA Breakthrough Device Designation for Quanterix's pTau-181 assay?
The FDA Breakthrough Device Designation allows Quanterix's pTau-181 assay to expedite the development and review process, indicating its potential impact in Alzheimer’s disease diagnosis.
How did Biogen's studies utilize Quanterix technology?
Biogen's Phase 3 EMERGE and ENGAGE studies employed Quanterix's Simoa HD-X technology to measure plasma pTau-181, demonstrating its correlation with cognitive decline reduction.
What role do plasma biomarkers play in Alzheimer's clinical trials according to Quanterix's findings?
Plasma biomarkers like pTau-181 and pTau-217 are crucial for early detection and tracking disease progression, facilitating a more efficient clinical trial process.
