Quanterix Granted Breakthrough Device Designation from U.S. FDA for Blood-Based p-Tau 217 Test for Alzheimer’s Disease

Rhea-AI Summary

Quanterix Corporation (QTRX) receives FDA Breakthrough Device designation for its p-Tau 217 blood test for Alzheimer's Disease diagnosis. The high-performing biomarker test aims to improve accessibility and accuracy in diagnosing AD, potentially revolutionizing patient care.

Positive

• Quanterix's p-Tau 217 blood test granted Breakthrough Device designation by the FDA for diagnosing Alzheimer's Disease.
• The test aims to offer a non-invasive and accessible alternative to traditional testing methods.
• Quanterix's dedication to AD biomarker research and development highlights its commitment to enhancing clinical diagnostics.
• The Simoa p-Tau 217 test utilizes high sensitivity methods to measure p-Tau 217 concentration in plasma.
• The Breakthrough Device designation recognizes the test's potential to impact AD diagnosis and treatment significantly.

Negative

• None.

Insights

Medical Research Analyst

The FDA's Breakthrough Device designation for Quanterix's Simoa® p-Tau 217 blood test represents a significant milestone in Alzheimer's Disease (AD) diagnostics. The designation acknowledges the test's potential to improve diagnostic processes for a condition with substantial unmet medical needs. The p-Tau 217 biomarker has been identified as a leading indicator for AD pathology, which signifies a pivotal shift from traditional, invasive diagnostic methods towards more patient-friendly, blood-based testing.

From a research perspective, the adoption of such tests could streamline AD diagnosis, potentially leading to earlier therapeutic interventions. The ability to diagnose AD non-invasively also opens the possibility for broader population screening, which could have profound effects on the management of the disease and on healthcare systems overall. This could lead to a demand for new protocols and standards in AD diagnosis, influencing both clinical practice and the development of therapeutic strategies.

Financial Analyst

Quanterix's announcement is likely to be closely monitored by investors and stakeholders due to the implications for the company's growth trajectory. The Breakthrough Device designation may not only enhance the company's reputation in the diagnostics field but also potentially accelerate the adoption of its testing technology. The market for AD diagnostics is expanding and Quanterix's positioning as a pioneer could lead to increased investor confidence and, possibly, a positive impact on its stock valuation.

However, it's important to note that the designation does not equate to FDA approval. Investors should be aware of the regulatory risks involved and the fact that the actual market impact will depend on successful completion of the FDA's review process, market acceptance and integration into clinical practice. The long-term financial implications hinge on these factors, as well as on the potential emergence of competing technologies and the overall trajectory of AD research and treatment approaches.

Healthcare Economist

The economic implications of a non-invasive, blood-based diagnostic test for Alzheimer's Disease are manifold. If the Simoa p-Tau 217 test becomes widely adopted, it could result in significant cost savings for healthcare systems by reducing the need for more expensive and invasive diagnostic procedures like PET scans and lumbar punctures. Furthermore, the earlier detection and subsequent management of AD could slow disease progression in some patients, thus delaying the onset of severe symptoms that require more intensive care and resources.

On the other hand, widespread adoption of blood-based biomarker testing could lead to increased overall testing volumes, which may present new challenges in terms of healthcare infrastructure and insurance coverage policies. The economic impact of such a diagnostic breakthrough will need to be evaluated in terms of cost-effectiveness and long-term outcomes for patients and healthcare systems alike.

BILLERICA, Mass.--(BUSINESS WIRE)-- Quanterix Corporation (NASDAQ: QTRX), a leading provider of ultra-sensitive research products and high-definition diagnostics, announced today that its Simoa^® phospho-Tau 217 (p-Tau 217) blood test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) as an aid in diagnostic evaluation of Alzheimer’s Disease (AD). The FDA’s Breakthrough Device designation is granted to products that have the potential to offer more effective diagnosis of life-threatening diseases with an unmet medical need.

p-Tau 217 has emerged as a top-performing biomarker for Alzheimer’s pathology, with the NIA-AA criteria identifying p-Tau 217 as the only plasma biomarker appropriate for accurately diagnosing amyloid pathology. Given that traditional testing methods of positron emission tomography (PET) or lumbar puncture for cerebrospinal fluid (CSF) biomarkers are invasive and commonly inaccessible, high-performing blood-based biomarker tests may be an appropriate alternative for patient care. As a pioneer in the AD biomarker field, Quanterix is dedicated to the development of ultrasensitive assay tests and enhancing clinical AD diagnostics through improved accessibility to blood biomarker tests.

“Early detection is crucial in shaping effective care strategies and improving patient outcomes,” said Masoud Toloue, CEO of Quanterix. “The breakthrough designation is an important step in our strategy to develop a global testing infrastructure for Alzheimer’s Disease. The FDA’s decision to grant Breakthrough Device Designation further validates the importance of accessible, non-invasive p-Tau 217 testing.”

The remarkable advancements in blood-based biomarkers made in AD research and diagnostics can be largely attributed to significant advancements in high sensitivity methods such as Quanterix’s Simoa^® technology, which paved the way with immunoassays for numerous blood-based biomarkers with potential diagnostic significance for Alzheimer’s. The Simoa p-Tau 217 test described in the Breakthrough Device application is a semi-quantitative in vitro diagnostic immunoassay intended for the measurement of p-Tau 217 concentration in plasma using the Quanterix HD-X immunoassay system. Proposed indications include use of the test results in patients presenting with cognitive impairment who are being evaluated for AD risk to aid in diagnostic evaluation. The test is not intended as a stand-alone diagnostic test and test results will be interpreted in conjunction with other diagnostic tools to establish a final clinical diagnosis.

The Breakthrough Device designation for the p-Tau 217 test underscores its potential to significantly impact Alzheimer's disease (AD) diagnosis and treatment. However, Breakthrough Device designation does not guarantee that the FDA review and approval process will be shortened or that an application will be approved.

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 2,700 peer-reviewed journals. Find additional information about the Billerica, Massachusetts-based company at https://www.quanterix.com or follow us on Twitter and LinkedIn.

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’s 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’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Quanterix’s 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240304898657/en/

Media:

Maya Nimnicht, PAN Communications

(510) 334-6273

pan.quanterix@pancomm.com

Investor Relations:

ir@quanterix.com

Source: Quanterix Corporation

FAQ

What is the significance of Quanterix Corporation's (QTRX) p-Tau 217 blood test receiving FDA Breakthrough Device designation?

The FDA granted Breakthrough Device designation to Quanterix's p-Tau 217 blood test for Alzheimer's Disease diagnosis, recognizing its potential to offer more effective diagnosis of life-threatening diseases with an unmet medical need.

How does the p-Tau 217 test by Quanterix Corporation aim to improve patient care?

The p-Tau 217 test aims to provide a non-invasive and accessible alternative to traditional testing methods like PET or lumbar puncture for diagnosing Alzheimer's Disease.

What is the intended use of Quanterix's Simoa p-Tau 217 test?

The Simoa p-Tau 217 test is a semi-quantitative in vitro diagnostic immunoassay intended for measuring p-Tau 217 concentration in plasma using the Quanterix HD-X immunoassay system.

Does the Breakthrough Device designation guarantee FDA approval for Quanterix's p-Tau 217 test?

No, the Breakthrough Device designation does not guarantee that the FDA review and approval process will be shortened or that an application will be approved.