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Quanterix (QTRX) AD Offering Gets FDA's Breakthrough Device Tag
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Quanterix Corporation (QTRX - Free Report) , a player in ultra-sensitive research products and diagnostics, achieved a significant milestone when the FDA granted a Breakthrough Device designation to its Simoa phospho-Tau 217 (p-Tau 217) blood test for Alzheimer's Disease (AD). The company claims that the p-Tau 217 biomarker is a highly promising tool for accurately diagnosing amyloid pathology.
The FDA’s Breakthrough Device designation is granted to products that have the potential to offer superior diagnosis of life-threatening diseases with an unmet medical need.
Transforming Alzheimer's Diagnostics
Traditional methods for assessing AD, such as positron emission tomography scans and lumbar punctures, are invasive and often inaccessible.
With early detection being pivotal in improving patient outcomes, the availability of a sensitive blood test for AD could significantly impact patient care. Quanterix's blood-based biomarker test offers a noninvasive alternative, potentially revolutionizing how AD is diagnosed and managed. The NIA-AA criteria identifies p-Tau 217 as the only plasma biomarker appropriate for accurately diagnosing amyloid pathology.
Image Source: Zacks Investment Research
Quanterix's Simoa technology has been instrumental in advancing blood-based biomarker research for AD. The high sensitivity of Simoa assays has enabled the detection of various biomarkers, including p-Tau 217, with unprecedented precision. This breakthrough underscores the potential of Quanterix's technology to transform AD diagnostics.
A Collaborative Diagnostic Approach
It's important to note that the p-Tau 217 test is not intended as a standalone diagnostic tool. Instead, it will complement existing diagnostic methods, facilitating a more comprehensive and accurate evaluation of AD risk in patients with cognitive impairment.
Market Prospects
Per a report by Future Market Insights, with a valuation of $3.05 billion in 2023, the global Alzheimer’s therapeutics market is poised for substantial growth at a CAGR of 9.2% to reach $ 7.36 billion by 2033. Factors such as the rising demand for effective treatments, escalating prevalence in aging populations and advancements in neuroscience research drive this expansion.
Share Price Performance
Shares of QTRX have surged 119.7% over the past year compared with the industry’s 8.8% growth.
Zacks Rank and Key Picks
Quanterix currently carries a Zacks Rank #4 (Sell).
Cardinal Health’s shares have risen 51.8% in the past year. Earnings estimates for the company have risen from $6.91 to $7.28 for fiscal 2024 and from $7.76 to $8.03 for fiscal 2025 in the past 30 days.
CAH’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 15.6%. In the last reported quarter, it delivered an earnings surprise of 16.7%.
Estimates for DaVita’s 2024 earnings per share (EPS) have moved from $8.46 to $8.97 in the past 30 days. Shares have soared 45.6% in the past year compared with the industry’s 7.9% growth.
DVA’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 35.6%. In the last reported quarter, it delivered an earnings surprise of 22.2%.
Estimates for Stryker’s 2024 EPS have increased from $11.79 to $11.86 in the past 30 days. The company's shares have moved 32% north in the past year, compared with the industry’s growth of 5.7%.
SYK’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 5.1%. In the last reported quarter, it delivered an earnings surprise of 5.8%.
Disclaimer: This article has been written with the assistance of Generative AI. However, the author has reviewed, revised, supplemented, and rewritten parts of this content to ensure its originality and the precision of the incorporated information.
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Quanterix (QTRX) AD Offering Gets FDA's Breakthrough Device Tag
Quanterix Corporation (QTRX - Free Report) , a player in ultra-sensitive research products and diagnostics, achieved a significant milestone when the FDA granted a Breakthrough Device designation to its Simoa phospho-Tau 217 (p-Tau 217) blood test for Alzheimer's Disease (AD). The company claims that the p-Tau 217 biomarker is a highly promising tool for accurately diagnosing amyloid pathology.
The FDA’s Breakthrough Device designation is granted to products that have the potential to offer superior diagnosis of life-threatening diseases with an unmet medical need.
Transforming Alzheimer's Diagnostics
Traditional methods for assessing AD, such as positron emission tomography scans and lumbar punctures, are invasive and often inaccessible.
With early detection being pivotal in improving patient outcomes, the availability of a sensitive blood test for AD could significantly impact patient care. Quanterix's blood-based biomarker test offers a noninvasive alternative, potentially revolutionizing how AD is diagnosed and managed. The NIA-AA criteria identifies p-Tau 217 as the only plasma biomarker appropriate for accurately diagnosing amyloid pathology.
Image Source: Zacks Investment Research
Quanterix's Simoa technology has been instrumental in advancing blood-based biomarker research for AD. The high sensitivity of Simoa assays has enabled the detection of various biomarkers, including p-Tau 217, with unprecedented precision. This breakthrough underscores the potential of Quanterix's technology to transform AD diagnostics.
A Collaborative Diagnostic Approach
It's important to note that the p-Tau 217 test is not intended as a standalone diagnostic tool. Instead, it will complement existing diagnostic methods, facilitating a more comprehensive and accurate evaluation of AD risk in patients with cognitive impairment.
Market Prospects
Per a report by Future Market Insights, with a valuation of $3.05 billion in 2023, the global Alzheimer’s therapeutics market is poised for substantial growth at a CAGR of 9.2% to reach $ 7.36 billion by 2033. Factors such as the rising demand for effective treatments, escalating prevalence in aging populations and advancements in neuroscience research drive this expansion.
Share Price Performance
Shares of QTRX have surged 119.7% over the past year compared with the industry’s 8.8% growth.
Zacks Rank and Key Picks
Quanterix currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the broader medical space are Cardinal Health (CAH - Free Report) , DaVita (DVA - Free Report) and Stryker (SYK - Free Report) . Cardinal Health and DaVita sport a Zacks Rank #1 (Strong Buy) each, while Stryker carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Cardinal Health’s shares have risen 51.8% in the past year. Earnings estimates for the company have risen from $6.91 to $7.28 for fiscal 2024 and from $7.76 to $8.03 for fiscal 2025 in the past 30 days.
CAH’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 15.6%. In the last reported quarter, it delivered an earnings surprise of 16.7%.
Estimates for DaVita’s 2024 earnings per share (EPS) have moved from $8.46 to $8.97 in the past 30 days. Shares have soared 45.6% in the past year compared with the industry’s 7.9% growth.
DVA’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 35.6%. In the last reported quarter, it delivered an earnings surprise of 22.2%.
Estimates for Stryker’s 2024 EPS have increased from $11.79 to $11.86 in the past 30 days. The company's shares have moved 32% north in the past year, compared with the industry’s growth of 5.7%.
SYK’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 5.1%. In the last reported quarter, it delivered an earnings surprise of 5.8%.
Disclaimer: This article has been written with the assistance of Generative AI. However, the author has reviewed, revised, supplemented, and rewritten parts of this content to ensure its originality and the precision of the incorporated information.