Quanterix submits FDA 510(k) for multi-analyte Alzheimer's blood test
Quanterix has submitted a 510(k) premarket notification to the FDA for its Lucent Diagnostics pTau-217 and Aβ42/40 Ratio Test. This multi-analyte blood test is intended to aid in the diagnosis of Alzheimer's disease and represents a significant step towards more accessible diagnostic tools for the condition. The submission marks a critical milestone for Quanterix in advancing its neurological diagnostic platform.
Quanterix Submits FDA 510(k) for Multi-Analyte Alzheimer's Blood Test
Quanterix (QTRX) has submitted a 510(k) premarket notification to the FDA for its multi-analyte algorithmic blood test for Alzheimer's disease diagnosis. The test, which uses Quanterix's Simoa technology, measures five Alzheimer's-related biomarkers and previously received FDA Breakthrough Device Designation. This submission is a significant step towards positioning the technology as a clinical diagnostic standard and could expand the company's addressable market for non-invasive Alzheimer's diagnostics.
Quanterix Submits FDA 510(k) for Multi-Analyte Alzheimer's Blood Test
Quanterix has submitted a 510(k) premarket notification to the FDA for its multi-analyte algorithmic blood test for Alzheimer's disease, marking a significant step in offering non-invasive diagnostic solutions. The test, built on the company's Simoa technology, measures five Alzheimer's-related biomarkers and received Breakthrough Device Designation. This submission positions Quanterix to become a standard in clinical diagnostics for early Alzheimer's identification.
Quanterix announces FDA 510(k) submission for a multi-analyte algorithmic blood test for Alzheimer’s disease detection
Quanterix has submitted a 510(k) application to the FDA for a multi-analyte algorithmic blood test designed for Alzheimer's disease detection. This submission, dated February 3, 2026, highlights the company's continuous efforts in advancing precision health diagnostics through its ultra-sensitive digital immunoassay platforms.
Quanterix (QTRX) Submits Alzheimer's Blood Test for FDA Approval
Quanterix (QTRX) has submitted a 510(k) premarket notification to the FDA for its innovative Alzheimer's blood test, which uses a multi-analyte algorithmic approach and Simoa technology to help diagnose the disease in patients with cognitive symptoms. Despite this significant step in early detection, the company faces financial challenges, including a negative operating margin, a potentially distressing Altman Z-Score, and high stock volatility. Investors are advised to consider both the opportunities presented by the technology and the associated financial and operational risks.
Quanterix submits FDA 510(k) for multi-analyte Alzheimer’s blood test
Quanterix Corporation has submitted a 510(k) premarket notification to the FDA for a multi-analyte algorithmic blood test designed to identify amyloid brain plaques in patients with cognitive symptoms, a key indicator of Alzheimer's disease. The test utilizes the company's Simoa technology to measure five biomarkers associated with amyloid pathology, tau pathology, neuroinflammation, and axonal damage. This submission is supported by extensive clinical evidence and marks a significant step towards establishing the technology as a standard in clinical diagnostics for early Alzheimer's detection.
Blood test to spot Alzheimer’s earlier moves to FDA review
Quanterix Corporation has submitted a 510(k) premarket notification to the FDA for a multi-analyte algorithmic blood test designed for early Alzheimer's disease detection. This test, previously granted Breakthrough Device Designation, aims to identify amyloid brain plaques using a panel of five biomarkers and Quanterix's Simoa technology. The company believes this non-invasive, comprehensive approach will improve diagnostic clarity for patients with cognitive symptoms, especially in early disease stages.
15-year brain study: blood test combo better flags Alzheimer’s risk
Quanterix Corporation announced a landmark study published in JAMA Network Open, demonstrating that combining multiple blood-based biomarkers offers a significantly more comprehensive and accurate assessment of Alzheimer's risk and progression compared to individual markers. The 15-year study, led by Amsterdam UMC, utilized Quanterix's Simoa ultra-sensitive technology to measure biomarkers for amyloid, tau, neuroinflammation, and neurodegeneration. These findings support Quanterix's multi-analyte laboratory developed tests, like LucentAD Complete, for personalized Alzheimer's risk assessment and clinical trial enrollment.
The Truth About Quanterix Corp (QTRX): Tiny Biotech, Massive Hype – But Is It Worth Your Money?
Quanterix Corp (QTRX) is a biotech company specializing in ultra-sensitive biomarker detection for early disease detection, particularly in neurology and inflammatory diseases. While not mainstream viral, it's gaining attention in specialized financial and medical tech communities due to its potential as a game-changer. Investors should be aware of its high-volatility, high-risk profile, making it suitable for long-term, research-heavy investors comfortable with biotech market swings rather than those seeking stable cash flow.
The Truth About Quanterix Corp (QTRX): Tiny Biotech, Massive Hype – But Is It Worth Your Money?
Quanterix Corp (QTRX) is a biotech company specializing in ultra-sensitive blood tests for early disease detection, particularly in neurology and inflammatory conditions. While it's gaining traction among specialist investors and researchers due to its innovative Simoa technology and platform-plus-assays model, it remains a high-risk, high-upside speculative play. Investors should be aware of its volatility and competitive landscape against larger diagnostic companies, weighing its strong technology against the need for scaled, profitable adoption.
Quanterix (QTRX) Price Target Increased by 11.54% to 7.40
The average one-year price target for Quanterix (QTRX) has been increased by 11.54% to $7.40 per share, up from $6.63. This target is an average of analyst estimates, with a range from $6.06 to $8.40. The current target represents a 3.35% increase from the latest closing price of $7.16.
Quanterix gains on CEO change, revenue guidance (update)
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Quanterix (NASDAQ: QTRX) appoints Everett Cunningham as CEO and director
Quanterix Corporation (NASDAQ: QTRX) has announced a significant leadership transition, appointing Everett Cunningham as its new President and CEO, effective January 19, 2026. This follows Masoud Toloue, Ph.D.'s departure under a separation agreement. Cunningham's compensation package includes a $750,000 annual base salary, performance-based bonuses, a $600,000 sign-on payment, and substantial equity awards tied to both time-based vesting and stock price hurdles, signaling a focus on performance-driven incentives.
Market Still Lacking Some Conviction On Quanterix Corporation (NASDAQ:QTRX)
Quanterix Corporation (NASDAQ:QTRX) currently has a price-to-sales (P/S) ratio of 2.9x, which is lower than the Life Sciences industry average in the United States, prompting a look into why. Despite a recent decline in revenue, analysts forecast a strong 17% annual revenue growth over the next three years, significantly outperforming the industry's projected 6.5% growth. This disparity between strong future growth forecasts and a low P/S ratio suggests that shareholders may be doubtful of the forecasts or that the market is pricing in significant risks.
Market Still Lacking Some Conviction On Quanterix Corporation (NASDAQ:QTRX)
Quanterix Corporation's (NASDAQ:QTRX) current price-to-sales (P/S) ratio of 2.9x is lower than the industry average, despite analyst forecasts predicting strong revenue growth of 17% per year over the next three years, compared to the industry's 6.5%. This discrepancy suggests that investors are hesitant about the company's future, possibly due to past revenue declines and perceived risks, even though the company's long-term growth prospects appear favorable. The article highlights that while future growth is projected positively, the market's current sentiment keeps the P/S ratio low.
Market Still Lacking Some Conviction On Quanterix Corporation (NASDAQ:QTRX)
Quanterix Corporation (NASDAQ:QTRX) has a price-to-sales (P/S) ratio of 2.9x, which is lower than many peers in the Life Sciences industry. This low P/S ratio is likely due to the company's recent declining revenue, despite future analyst forecasts predicting strong revenue growth of 17% per year, significantly outpacing the industry average. The market appears to be skeptical of these positive forecasts, leading to a depressed P/S ratio.
Canaccord Genuity reiterates Hold rating on Quanterix stock
Canaccord Genuity has reiterated its Hold rating and $8.00 price target for Quanterix Corp. (NASDAQ:QTRX), citing a potential 23% upside. The firm acknowledges the appointment of Everett Cunningham as the new President and CEO, seeing his background as a strong fit, but remains cautious awaiting clarity on his priorities and consistent operational execution due to the company's significant cash burn. Quanterix's Q3 2025 revenue exceeded forecasts, but EPS missed expectations, while the company continues to contribute to medical research with its biomarker technology.
Canaccord Genuity reiterates Hold rating on Quanterix stock By Investing.com
Canaccord Genuity has reiterated a Hold rating and an $8.00 price target for Quanterix Corp. (NASDAQ:QTRX), indicating a potential 23% upside. The company recently appointed Everett Cunningham as its new President and CEO, effective January 19, 2026. Despite a positive view on the new CEO's background, Canaccord Genuity remains cautious, awaiting clarity on his priorities and consistent operational execution, especially given Quanterix's cash burn and revenue decline, although it maintains strong liquidity.
Quanterix Stock: Can This High-Beta Diagnostics Play Turn Volatility Into Long-Term Alpha?
Quanterix shares have seen a significant multi-month rally, recovering from earlier skepticism, but have recently entered a choppy, corrective phase, leaving traders cautious. Despite the recent pullback, the stock has more than doubled over the past year, reflecting improved sentiment and progress in ultra-sensitive blood diagnostics, particularly in neurology. The company's future hinges on robust revenue growth in its neurology franchise, successful expansion into regulated clinical-grade assays, and careful management of its cash burn and competitive landscape.
Quanterix (NASDAQ:QTRX) Raised to Hold at Wall Street Zen
Wall Street Zen upgraded Quanterix (NASDAQ:QTRX) from "sell" to "hold," giving the stock a consensus "Hold" rating with an average analyst target of $11.33. This upgrade follows news that Canaccord Genuity Group recently raised its target price to $8.00. Despite missing Q3 EPS estimates, Quanterix's revenue of $40.23 million beat expectations, and the company currently trades at $6.46 with a market capitalization of $301.75 million.
Quanterix Announces Landmark Nature Study Redefining Alzheimer’s Disease Neuropathology Prevalence
Quanterix announced the publication of a landmark study in Nature, which utilized its Simoa p-Tau 217 assay to conduct the largest population-based assessment of Alzheimer’s Disease Neuropathological Changes (ADNC) to date. The study, involving over 11,000 individuals, revealed a striking age-related increase in ADNC prevalence and provides crucial data for public health and pharmaceutical planning. This research redefines disease prevalence and identifies asymptomatic individuals who may benefit from early intervention.
Quanterix announces landmark Nature study redefining Alzheimer's disease Neuropathology prevalence
Quanterix Corporation announced a landmark study published in Nature that redefines the prevalence of Alzheimer's disease neuropathology. The article provides details on Quanterix's current stock performance, analyst recommendations, and recent company news, including board changes and earnings reports. It also outlines the company's profile, highlighting its ultra-sensitive digital immunoassay platforms for life sciences research and diagnostics.
Quanterix (NASDAQ:QTRX) Given New $8.00 Price Target at Canaccord Genuity Group
Canaccord Genuity Group has increased its price target for Quanterix (NASDAQ:QTRX) to $8.00 from $5.00, maintaining a "hold" rating, which suggests a 21.40% upside. This adjustment comes despite Quanterix missing EPS estimates but exceeding revenue expectations in its latest earnings report. The company remains unprofitable, and institutional investors hold a significant portion of its shares.
Quanterix (QTRX) Study Sheds Light on Alzheimer's Prevalence
Quanterix (QTRX) has published a significant study in Nature utilizing its ultra-sensitive Simoa p-Tau 217 assay, which evaluated over 11,000 Norwegians and revealed a higher prevalence of Alzheimer's Disease Neuropathological Changes (ADNC) with age than previously thought. This research provides scalable data to redefine disease prevalence, identify asymptomatic individuals for early intervention, and established correlations between sex, APOE genotype, and education level. Despite this scientific advancement, the company faces financial challenges, as indicated by a low Piotroski F-Score and an Altman Z-Score in the distress zone.
Blood test study finds hidden Alzheimer’s changes in 1 in 10 older adults
Quanterix Corporation announced the publication of a landmark study in Nature, utilizing its ultra-sensitive Simoa p-Tau 217 research assay to assess Alzheimer’s Disease Neuropathological Changes (ADNC) in over 11,000 individuals. The study revealed a significant age-related increase in ADNC prevalence, from 10% in those aged 58-69.9 to 64.9% in those over 90, providing crucial data for public health planning and pharmaceutical development. These findings enable more accurate identification of asymptomatic individuals who may benefit from early intervention or clinical trials.
Quanterix Announces Landmark Nature Study Redefining Alzheimer’s Disease Neuropathology Prevalence
Quanterix announced a landmark study published in Nature utilizing its Simoa p-Tau 217 assay, which revealed a striking age-related increase in Alzheimer's Disease Neuropathological Changes (ADNC) among over 11,000 individuals. The study provides crucial data on the prevalence of ADNC in a general population, highlighting a higher prevalence in older individuals than previously estimated and identifying asymptomatic individuals who could benefit from early intervention. This research is expected to inform public health authorities and the pharmaceutical industry in planning for future Alzheimer's care and disease-modifying therapies.
Quanterix (NASDAQ:QTRX) Lowered to "Sell" Rating by Wall Street Zen
Wall Street Zen has downgraded Quanterix (NASDAQ:QTRX) from a "hold" to a "sell" rating, with Weiss Ratings reaffirming a "sell." Despite revenue beating expectations, the company reported a net loss per share of ($0.36), missing estimates, and analysts forecast a negative EPS for the current year. The stock opened at $6.59 and has a consensus price target of $10.33 from analysts.
Quanterix (QTRX) Projected to Post Earnings on Monday
Quanterix (NASDAQ: QTRX) is expected to announce its earnings before market open on Monday, December 22nd, with analysts forecasting a loss of ($0.23) per share. The company previously missed estimates with ($0.36) EPS but exceeded revenue expectations at $40.23 million. Quanterix faces continued unprofitability with negative net margin and ROE, and its stock currently holds a consensus "Hold" rating from analysts with a target price of $10.33.
Quanterix (NASDAQ:QTRX) Upgraded by Wall Street Zen to "Hold" Rating
Wall Street Zen upgraded Quanterix (NASDAQ:QTRX) from a "sell" to a "hold" rating, while Weiss Ratings maintains a "sell (D-)" and the overall analyst consensus is still "Hold" with an average price target of $10.33. Despite revenue beating estimates at $40.23 million, Quanterix reported an EPS loss of $0.36, missing estimates, and remains unprofitable with a negative net margin and ROE. Shares opened at $7.56, and institutional investors own a significant portion of the company's stock.
Quanterix Corporation (NASDAQ:QTRX) Given Consensus Recommendation of "Hold" by Analysts
Analysts have issued a consensus "Hold" rating for Quanterix Corporation (NASDAQ:QTRX), with an average 12-month price target of $10.33. The company reported mixed third-quarter results, missing EPS estimates but exceeding revenue expectations, and remains unprofitable with a negative net margin. Institutional investors hold a significant portion of the stock, and several funds recently increased their positions.
Emocog brings Quanterix’s ultra-sensitive Alzheimer’s blood test platform to Korea
Emocog has signed an exclusive agreement with Quanterix Corp. to introduce the Simoa ultra-high-sensitivity protein analysis platform and blood-based diagnostic reagents for Alzheimer's screening in Korea. This marks the first time the Simoa platform will be formally used as an in vitro diagnostic medical device (IVD) in Korea, moving beyond research-use-only applications. Emocog aims to establish an integrated cognitive health ecosystem combining digital assessment, cognitive intervention, and blood-based diagnostics for early Alzheimer's detection.
Russell Investments Group Ltd. Has $2.82 Million Stock Holdings in Quanterix Corporation $QTRX
Russell Investments Group Ltd. decreased its stake in Quanterix Corporation (NASDAQ:QTRX) by 30.0% in the second quarter, now holding 424,659 shares valued at approximately $2.82 million. Despite this, other institutions like William Blair Investment Management LLC and Geode Capital Management LLC increased their positions. Analyst sentiment for Quanterix is mixed, with a consensus "Hold" rating and a target price of $10.33, after the company missed profitability estimates with a reported EPS of ($0.36).
Even after rising 26% this past week, Quanterix (NASDAQ:QTRX) shareholders are still down 83% over the past five years
Quanterix Corporation (NASDAQ:QTRX) has seen a recent 63% increase in its stock price over the last quarter, including a 26% rise this past week. Despite this, long-term shareholders are still down 83% over the past five years. The company's revenue has increased by 8.0% annually over five years, but its stock has declined by 13% per year, and it continues to operate without profit.
Quanterix Announces Board and Leadership Changes
Quanterix Corporation (NASDAQ: QTRX) announced significant leadership and governance enhancements, including the appointment of Dr. Garret Hampton and Dr. Alan Sachs to its Board of Directors. Bill Donnelly was named Executive Chair, and Jeffrey Elliott was appointed Lead Independent Director. These changes aim to support the company's next phase of growth and strategic initiatives, particularly after the Akoya acquisition.
Quanterix Corporation (NASDAQ:QTRX) Receives Consensus Rating of "Hold" from Analysts
Quanterix Corporation (NASDAQ:QTRX) has received a "Hold" consensus rating from five analysts, with an average one-year price target of $10.33. The company recently missed EPS estimates but beat revenue expectations, and analysts project a negative EPS of -0.98 for the current fiscal year. Despite the mixed financial performance, institutional investors and hedge funds hold a significant portion of the stock.
Quanterix (NASDAQ: QTRX) schedules results call for Nov. 10 with live webcast
Quanterix Corporation (NASDAQ: QTRX) announced it will host a conference call on Monday, November 10, 2025, at 4:30 p.m. E.T. to discuss its third quarter 2025 financial results. The company will issue a press release with these results before the call, and investors can access the live webcast via the Quanterix website.
Quanterix (NASDAQ: QTRX) Study Backs Dual GFAP/NfL Blood Test for MS Monitoring
Quanterix announced a landmark study published in 'Brain,' validating a dual GFAP/NfL blood test for personalized Multiple Sclerosis (MS) monitoring. The study highlights that elevated GFAP levels predict progression independent of relapse activity (PIRA), while NfL remains a gold standard for acute activity, offering a comprehensive assessment for MS patients. The Simoa-based assays, supported by extensive normative data infrastructure, allow for individualized patient interpretation, addressing a critical unmet need in MS disease monitoring.
FY2025 EPS Estimates for Quanterix Cut by Leerink Partnrs
Leerink Partnrs has reduced its FY2025 EPS estimate for Quanterix to ($1.47) from ($1.25), significantly below the consensus of ($0.98). This follows Quanterix missing its most recent quarterly EPS estimates, though revenue beat expectations. Analyst sentiment remains mixed, with an average "Hold" rating and a target price of $10.33 against the current trading price of around $5.22.
Quanterix Corporation (NASDAQ:QTRX) Q3 2025 Earnings Call Transcript
Quanterix Corporation (NASDAQ:QTRX) reported its Q3 2025 earnings, missing EPS expectations. Despite challenging industry conditions, the company delivered on revenue, progressing swiftly with the Akoya acquisition integration, achieving $67 million of its $85 million synergy target. Quanterix is focusing on Alzheimer's diagnostics, new assay development for its Simoa and Spatial franchises, and expects to be cash flow breakeven in 2026.
Quanterix Corporation (QTRX) Reports Q3 Loss, Tops Revenue Estimates
Quanterix Corporation (QTRX) reported a Q3 loss of $0.36 per share, missing the Zacks Consensus Estimate of a $0.23 loss, and underperforming prior year's loss of $0.22 per share. However, the company surpassed revenue expectations, posting $40.23 million against an estimated $38.62 million. Despite topping revenue estimates in three of the last four quarters, Quanterix's stock has seen a significant year-to-date decline and currently holds a Zacks Rank #4 (Sell).
Quanterix (NASDAQ: QTRX) reports Q3 revenue $40.2M; $67M synergies captured
Quanterix Corporation (NASDAQ: QTRX) announced its Q3 2025 financial results, reporting revenue of $40.2 million, up 12.3% year-over-year. The company reiterated its full-year 2025 revenue guidance of $130 to $135 million and highlighted the capture of $67 million in cost synergies from its Akoya acquisition, remaining on track for cash flow break-even in 2026.
Q2 Earnings Forecast for Quanterix Issued By Leerink Partnrs
Leerink Partnrs has issued an earnings forecast for Quanterix (NASDAQ: QTRX) ahead of its Q2 earnings report. Other brokerages, including Canaccord Genuity Group, have also recently commented on Quanterix, with institutional investors significantly increasing their holdings in the company. The article also provides an overview of Quanterix Corporation's business, which involves the development and marketing of digital immunoassay platforms.
Quanterix CFO Sriram buys $19,878 in company stock
Quanterix CFO Vandana Sriram purchased 4,150 shares of the company's common stock for $19,878 on September 12, 2025, according to an SEC filing. This transaction brings Sriram's direct ownership to 87,200 shares, including restricted stock units, and occurs as the stock trades below its Fair Value despite recent gains. The purchase follows Quanterix's Q2 2025 earnings miss and a downgrade by Canaccord Genuity, though the company recently expanded its biomarker research capabilities with a new clinical laboratory permit in New York.
Market Cool On Quanterix Corporation's (NASDAQ:QTRX) Revenues Pushing Shares 29% Lower
Quanterix Corporation's shares have dropped significantly, losing 29% in the past month and 65% over the last year, leading to a low price-to-sales (P/S) ratio of 1.7x compared to the industry average. Despite declining revenues in the past year, analysts project a 20% annual revenue growth for Quanterix over the next three years, substantially higher than the industry forecast of 6.9%. This suggests that while concerns about future volatility might be depressing the stock price, the company's valuation appears to be significantly depressed given its strong forecasted revenue growth.
Quanterix Accelerator Laboratory Awarded Rigorous New York State Clinical Laboratory Permit
Quanterix Corporation's Accelerator Laboratory has received a clinical laboratory permit from the New York State Department of Health, expanding its advanced biomarker research capabilities. This approval means the lab is now fully CLIA-certified in all 50 states, enhancing its commitment to accuracy and reliability in clinical testing and biomarker analysis. The permit allows for broader collaboration with clinical, pharmaceutical, and research partners, particularly within New York's rigorous healthcare market.
Quanterix Corporation (NASDAQ:QTRX) Q2 2025 Earnings Call Transcript
Quanterix Corporation discussed its Q2 2025 earnings, highlighting significant progress since their last call, including the acquisition of Akoya and strategic investments. Despite a revenue decline to $24 million due to academic funding and biopharma spending headwinds, the company is focused on long-term growth, margin improvement, and achieving cash flow positivity by 2026. They've implemented 75% of the projected $85 million in synergy savings and cost reductions, aiming to capitalize on the expanding proteomics market with their Simoa and Spatial platforms.
Canaccord Genuity downgrades Quanterix stock to Hold on weak outlook
Canaccord Genuity has downgraded Quanterix Corp. (NASDAQ: QTRX) from Buy to Hold and significantly reduced its price target to $5.00 from $12.00, citing a lack of near-term visibility and catalysts. This downgrade follows Quanterix's weak Q2 2025 results, which missed analyst expectations for both EPS and revenue, alongside a significant cut in its core Simoa revenue guidance. The company faces challenging macroeconomic conditions and integration issues with spatial biology company Akoya Biosciences, raising concerns about deal cash flow targets and potential negative impacts on top-line growth.
Quanterix Q2 2025 slides: Revenue drops 29% as company charts path to profitability
Quanterix (NASDAQ: QTRX) reported a 29% year-over-year revenue decline in Q2 2025 due to constrained biopharma budgets and the integration of its Akoya acquisition, with revenue falling to $24.5 million. The company is pursuing a strategic transformation, including aggressive cost reductions targeting $85 million in savings and a focus on high-margin consumables and Alzheimer's diagnostics, to achieve cash flow positivity by 2026. Despite financial challenges and widening operating losses, Quanterix maintains a strong cash balance and is advancing its Alzheimer’s testing platform and scientific validation of its Simoa technology.
Fujirebio Sues Quanterix to Protect Alzheimer’s Test Rollout
Fujirebio Diagnostics, the developer of the first FDA-approved blood test for Alzheimer's disease, has filed a lawsuit against Quanterix Corp. Fujirebio seeks a federal court ruling that its Lumipulse plasma assay does not infringe upon a Quanterix patent. The lawsuit aims to ensure a clear path for Fujirebio's planned US launch of its Alzheimer's test in late June.
Quanterix Corp expected to post a loss of 44 cents a share - Earnings Preview
Quanterix Corp (QTRX) is projected to report a loss of 44 cents per share and a 12.0% decrease in quarterly revenue to $28.203 million for the period ending March 31, 2025. This forecast aligns with the company's guidance and LSEG data, with analysts maintaining a "buy" rating on the stock. The median 12-month price target for QTRX is $12.00, significantly higher than its last closing price of $5.28.
