Quanterix Submits Blood Test for Alzheimer's Disease to FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1d ago
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Should l Buy QTRX?
Source: Newsfilter
- Significant Milestone: Quanterix has submitted a 510(k) premarket notification for a multi-analyte algorithmic blood test for Alzheimer's disease, marking a crucial advancement in the company's mission to provide non-invasive, high-performance diagnostic tools for evaluating patients with cognitive symptoms.
- Breakthrough Device Designation: The test has received Breakthrough Device Designation from the FDA, aimed at accelerating the development and review process, highlighting its potential in addressing life-threatening or irreversibly debilitating diseases.
- Comprehensive Biomarkers: Utilizing Quanterix's Simoa® technology, the test integrates five key analytes—p-Tau 217, Aβ42, Aβ40, GFAP, and NfL—offering a more comprehensive assessment of Alzheimer's biological drivers than single-analyte assays, particularly in the early stages of disease progression.
- Clinical Validation Support: The submission is backed by extensive clinical evidence published in Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring, spanning three independent cohorts and over 1,800 symptomatic patients, demonstrating the test's effectiveness and reliability.
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Analyst Views on QTRX
Wall Street analysts forecast QTRX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for QTRX is 7.50 USD with a low forecast of 7.00 USD and a high forecast of 8.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
0 Buy
2 Hold
0 Sell
Hold
Current: 6.450
Low
7.00
Averages
7.50
High
8.00
Current: 6.450
Low
7.00
Averages
7.50
High
8.00
About QTRX
Quanterix Corporation is engaged in fueling scientific discovery through ultra-sensitive biomarker detection. The Company’s Simoa technology delivers earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the level of quantification (LoQ). Its 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. Its products and services include Simoa Assay Kits, Simoa Dry Blood Extraction Kit, LDTs & Assay Services, Instruments, Simoa Accelerator Laboratory, Homebrew-Custom Assay Development, and Nova Beads. LDTs & Assay Services include Simoa p-Tau 217, Simoa NfL LDT, and LucentAD pTau 217. Its instruments include Simoa HD-X Analyzer-Automated Immunoassays, Quanterix SR-X Biomarker Detection System, and SP-X Imaging and Analysis System.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Quanterix Submits Blood Test for Alzheimer's Disease to FDA
- Significant Milestone: Quanterix has submitted a 510(k) premarket notification for a multi-analyte algorithmic blood test for Alzheimer's disease, marking a crucial advancement in the company's mission to provide non-invasive, high-performance diagnostic tools for evaluating patients with cognitive symptoms.
- Breakthrough Device Designation: The test has received Breakthrough Device Designation from the FDA, aimed at accelerating the development and review process, highlighting its potential in addressing life-threatening or irreversibly debilitating diseases.
- Comprehensive Biomarkers: Utilizing Quanterix's Simoa® technology, the test integrates five key analytes—p-Tau 217, Aβ42, Aβ40, GFAP, and NfL—offering a more comprehensive assessment of Alzheimer's biological drivers than single-analyte assays, particularly in the early stages of disease progression.
- Clinical Validation Support: The submission is backed by extensive clinical evidence published in Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring, spanning three independent cohorts and over 1,800 symptomatic patients, demonstrating the test's effectiveness and reliability.
See More
Quanterix Publishes Landmark Alzheimer’s Study with C-Index of 0.90
- Significant Findings: Quanterix's study published in JAMA Network Open demonstrates that a multi-biomarker model achieves a high C-index of 0.90 for clinical risk assessment, significantly enhancing the identification of early symptoms of Alzheimer’s disease.
- Cutting-Edge Technology: Utilizing ultra-sensitive Simoa® technology to measure four critical biological axes of Alzheimer’s, the research indicates that the combined use of multiple biomarkers provides a more comprehensive view of clinical risk, advancing early diagnosis of the disease.
- Innovative Product Leadership: The launch of LucentAD Complete, based on biomarkers evaluated in the study, aims to provide a comprehensive amyloid risk score for symptomatic individuals, marking Quanterix's leadership in Alzheimer’s diagnostics.
- Clinical Application Prospects: The study underscores the importance of identifying potential fast progressors, with Quanterix's multi-analyte approach offering new solutions for clinical trial enrollment and patient care, driving the evolution of personalized medicine.
See More
Rich Sparkle Holdings Signs $39 Million Share Offering Agreement
- Stock Surge: Rich Sparkle Holdings Ltd's shares skyrocketed 115% to $52.00 following the signing of a $39 million agreement for 3 million ordinary shares, indicating strong market confidence in its financing strategy.
- Positive Market Reaction: The offering price of $13 per share is significantly lower than the current market price, reflecting optimistic investor expectations regarding the company's growth potential, which may provide essential funding for future expansions.
- Significant Industry Impact: The successful financing of Rich Sparkle Holdings not only enhances its market position but could also attract more investor attention to the sector, potentially driving up stock prices of related companies.
- Optimistic Future Outlook: With the influx of capital, the company is poised to accelerate its business development and market expansion, further solidifying its competitive advantage in the industry.
See More
CG Oncology Accelerates Phase 3 Data Readout to First Half of 2026
- Significant Stock Surge: Shares of CG Oncology Inc soared 21.8% to $51.05 after the announcement of an expedited topline data readout for the PIVOT-006 clinical trial, reflecting strong market confidence in the company's future prospects.
- Clinical Trial Advancement: The trial compares adjuvant intravesical treatment versus surveillance in patients with intermediate-risk non-muscle invasive bladder cancer, and the earlier data release is expected to attract more investor interest, further propelling the company's growth.
- Positive Market Reaction: This stock price increase not only indicates investor optimism about CG Oncology's potential but may also enhance the company's financing capabilities in the biopharmaceutical sector, strengthening its competitive position.
- Significant Industry Impact: CG Oncology's progress could influence treatment standards for non-muscle invasive bladder cancer, prompting other companies in the industry to accelerate their R&D efforts, thereby boosting overall market vitality.
See More
Quanterix Appoints Everett Cunningham as New CEO Effective January 19, 2026
- Leadership Transition: Quanterix has appointed Everett Cunningham as the new CEO, succeeding current CEO Masoud Toloue, effective January 19, 2026, aimed at ensuring continuity and stability during the leadership transition period.
- Extensive Industry Experience: Cunningham's tenure as Chief Commercial Officer at Illumina saw him successfully implement global commercial strategies that improved customer engagement, which is expected to drive similar growth momentum for Quanterix in the biomarker detection field.
- Shareholder Value Enhancement: Following Cunningham's appointment, Quanterix anticipates exceeding its revenue and cash guidance for 2025, indicating strong market performance and growth potential, thereby boosting shareholder confidence.
- Strategic Planning: This appointment is part of Quanterix's long-term succession planning, with the Board conducting a comprehensive search through a leading executive search firm to ensure the selection of a suitable leader to drive the company's future growth.
See More
Quanterix Unveils Leadership and Board Changes to Facilitate Future Growth
Leadership Appointments: Quanterix Corporation has appointed Garret Hampton, Ph.D., and Alan Sachs, M.D., Ph.D., to its Board of Directors, while William Donnelly has been named Executive Chair and Jeffrey Elliott as Lead Independent Director.
Strategic Focus: The leadership changes aim to support Quanterix's growth initiatives, including expanding its biomarker offerings and launching new diagnostic tools, particularly for Alzheimer's disease.
Board Composition Changes: Paul Meister and David Walt, Ph.D., are stepping down from the Board, leaving Quanterix with a total of nine board members, seven of whom are independent.
Future Outlook: The new board members bring extensive experience in life sciences and diagnostics, which is expected to enhance Quanterix's strategic direction and operational alignment as it integrates recent acquisitions and focuses on growth.
See More
Quanterix Submits Blood Test for Alzheimer's Disease to FDA
- Significant Milestone: Quanterix has submitted a 510(k) premarket notification for a multi-analyte algorithmic blood test for Alzheimer's disease, marking a crucial advancement in the company's mission to provide non-invasive, high-performance diagnostic tools for evaluating patients with cognitive symptoms.
- Breakthrough Device Designation: The test has received Breakthrough Device Designation from the FDA, aimed at accelerating the development and review process, highlighting its potential in addressing life-threatening or irreversibly debilitating diseases.
- Comprehensive Biomarkers: Utilizing Quanterix's Simoa® technology, the test integrates five key analytes—p-Tau 217, Aβ42, Aβ40, GFAP, and NfL—offering a more comprehensive assessment of Alzheimer's biological drivers than single-analyte assays, particularly in the early stages of disease progression.
- Clinical Validation Support: The submission is backed by extensive clinical evidence published in Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring, spanning three independent cohorts and over 1,800 symptomatic patients, demonstrating the test's effectiveness and reliability.
See More
Quanterix Publishes Landmark Alzheimer’s Study with C-Index of 0.90
- Significant Findings: Quanterix's study published in JAMA Network Open demonstrates that a multi-biomarker model achieves a high C-index of 0.90 for clinical risk assessment, significantly enhancing the identification of early symptoms of Alzheimer’s disease.
- Cutting-Edge Technology: Utilizing ultra-sensitive Simoa® technology to measure four critical biological axes of Alzheimer’s, the research indicates that the combined use of multiple biomarkers provides a more comprehensive view of clinical risk, advancing early diagnosis of the disease.
- Innovative Product Leadership: The launch of LucentAD Complete, based on biomarkers evaluated in the study, aims to provide a comprehensive amyloid risk score for symptomatic individuals, marking Quanterix's leadership in Alzheimer’s diagnostics.
- Clinical Application Prospects: The study underscores the importance of identifying potential fast progressors, with Quanterix's multi-analyte approach offering new solutions for clinical trial enrollment and patient care, driving the evolution of personalized medicine.
See More
Rich Sparkle Holdings Signs $39 Million Share Offering Agreement
- Stock Surge: Rich Sparkle Holdings Ltd's shares skyrocketed 115% to $52.00 following the signing of a $39 million agreement for 3 million ordinary shares, indicating strong market confidence in its financing strategy.
- Positive Market Reaction: The offering price of $13 per share is significantly lower than the current market price, reflecting optimistic investor expectations regarding the company's growth potential, which may provide essential funding for future expansions.
- Significant Industry Impact: The successful financing of Rich Sparkle Holdings not only enhances its market position but could also attract more investor attention to the sector, potentially driving up stock prices of related companies.
- Optimistic Future Outlook: With the influx of capital, the company is poised to accelerate its business development and market expansion, further solidifying its competitive advantage in the industry.
See More
CG Oncology Accelerates Phase 3 Data Readout to First Half of 2026
- Significant Stock Surge: Shares of CG Oncology Inc soared 21.8% to $51.05 after the announcement of an expedited topline data readout for the PIVOT-006 clinical trial, reflecting strong market confidence in the company's future prospects.
- Clinical Trial Advancement: The trial compares adjuvant intravesical treatment versus surveillance in patients with intermediate-risk non-muscle invasive bladder cancer, and the earlier data release is expected to attract more investor interest, further propelling the company's growth.
- Positive Market Reaction: This stock price increase not only indicates investor optimism about CG Oncology's potential but may also enhance the company's financing capabilities in the biopharmaceutical sector, strengthening its competitive position.
- Significant Industry Impact: CG Oncology's progress could influence treatment standards for non-muscle invasive bladder cancer, prompting other companies in the industry to accelerate their R&D efforts, thereby boosting overall market vitality.
See More
Quanterix Appoints Everett Cunningham as New CEO Effective January 19, 2026
- Leadership Transition: Quanterix has appointed Everett Cunningham as the new CEO, succeeding current CEO Masoud Toloue, effective January 19, 2026, aimed at ensuring continuity and stability during the leadership transition period.
- Extensive Industry Experience: Cunningham's tenure as Chief Commercial Officer at Illumina saw him successfully implement global commercial strategies that improved customer engagement, which is expected to drive similar growth momentum for Quanterix in the biomarker detection field.
- Shareholder Value Enhancement: Following Cunningham's appointment, Quanterix anticipates exceeding its revenue and cash guidance for 2025, indicating strong market performance and growth potential, thereby boosting shareholder confidence.
- Strategic Planning: This appointment is part of Quanterix's long-term succession planning, with the Board conducting a comprehensive search through a leading executive search firm to ensure the selection of a suitable leader to drive the company's future growth.
See More
Quanterix Unveils Leadership and Board Changes to Facilitate Future Growth
Leadership Appointments: Quanterix Corporation has appointed Garret Hampton, Ph.D., and Alan Sachs, M.D., Ph.D., to its Board of Directors, while William Donnelly has been named Executive Chair and Jeffrey Elliott as Lead Independent Director.
Strategic Focus: The leadership changes aim to support Quanterix's growth initiatives, including expanding its biomarker offerings and launching new diagnostic tools, particularly for Alzheimer's disease.
Board Composition Changes: Paul Meister and David Walt, Ph.D., are stepping down from the Board, leaving Quanterix with a total of nine board members, seven of whom are independent.
Future Outlook: The new board members bring extensive experience in life sciences and diagnostics, which is expected to enhance Quanterix's strategic direction and operational alignment as it integrates recent acquisitions and focuses on growth.
See More
