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

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.