BILLERICA, Mass. - Quanterix (NASDAQ:QTRX) Corporation (NASDAQ: QTRX), a company specializing in ultra-sensitive research products and high-definition diagnostics, recently received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its blood test aimed at diagnosing Alzheimer's Disease (AD). The test measures the concentration of phospho-Tau 217 (p-Tau 217), a biomarker associated with Alzheimer's pathology.
The FDA's Breakthrough Device designation is reserved for products that could provide more effective diagnosis for serious diseases with unmet medical needs. The p-Tau 217 biomarker is recognized by the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria as a plasma biomarker suitable for accurately diagnosing amyloid pathology, a hallmark of Alzheimer's disease.
Current diagnostic methods, such as positron emission tomography (PET) scans or lumbar punctures for cerebrospinal fluid (CSF) biomarkers, are invasive and not always accessible. Quanterix's blood-based biomarker test presents a non-invasive alternative that could be more accessible for patient care.
Masoud Toloue, CEO of Quanterix, emphasized the significance of the breakthrough designation as a step forward in creating a global testing infrastructure for Alzheimer's Disease. The designation validates the importance of non-invasive p-Tau 217 testing, which could lead to earlier detection and better patient outcomes.
The Simoa p-Tau 217 test operates on the Quanterix HD-X immunoassay system and is intended as a semi-quantitative in vitro diagnostic tool. It is not meant to be used in isolation but rather in conjunction with other diagnostic methods to aid in evaluating AD risk in patients with cognitive impairment.
While the Breakthrough Device designation highlights the test's potential to significantly impact AD diagnosis, it does not ensure an expedited FDA review or approval.
Quanterix's Simoa technology is known for its high sensitivity in detecting biomarkers at levels lower than the conventional methods' limit of quantification, supporting research across various therapeutic areas, including neurology, oncology, and cardiology.
The information in this article is based on a press release statement from Quanterix Corporation.
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