Breaking Ground in Alzheimer’s Diagnosis: Simoa® p-Tau 217 Blood Test Receives FDA Breakthrough Device Designation thumbnail image

Breaking Ground in Alzheimer’s Diagnosis: Simoa® p-Tau 217 Blood Test Receives FDA Breakthrough Device Designation

Alzheimer’s disease (AD), a progressive neurodegenerative disorder, remains one of the most challenging health crises of our time. Despite decades of research, effective diagnosis and treatments remain elusive, while the burden on patients, families, and healthcare systems continues to grow.  However, the recent advancements in biomarker technology offer new hope. Quanterix has achieved a significant milestone with the Simoa® phospho-Tau 217 (p-Tau 217) blood test, receiving Breakthrough Device designation from the U.S. Food and Drug Administration (FDA)1 as an aid in diagnostic evaluation of Alzheimer’s Disease (AD). This designation signifies a pivotal moment in Alzheimer’s research, with the potential to transform the trajectory of the diagnostic evaluation and treatment strategies for this debilitating disease.

Introducing Quanterix’s Breakthrough Device Designation

The Simoa® p-Tau 217 blood test has emerged as a top-performing biomarker for Alzheimer’s pathology detection, with the diagnostic criteria of the Alzheimer’s Association working group, which identifies p-Tau 217 as the sole plasma biomarker appropriate for accurately diagnosing amyloid pathology2. The FDA granted Breakthrough Device designation to the Simoa® p-Tau 217 blood test as an aid in diagnostic evaluation of AD, highlighting its potential to assist in more effective diagnosis of AD, a life-threatening condition with an unmet medical need. This non-invasive blood test provides a potential alternative to costly and invasive methods like positron emission tomography (PET) or lumbar puncture for cerebrospinal fluid (CSF) biomarkers, enhancing accessibility to diagnostic tools for patients and clinicians alike.

Empowering Early Detection and Care Strategies

“Early detection is crucial in shaping effective care strategies and improving patient outcomes,” emphasized 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,” he added.

Quanterix’s commitment to developing a global testing infrastructure for Alzheimer’s disease aligns with the urgent need for reliable biomarker assays to aid in early diagnosis and intervention. In addition to Simoa® p-Tau 217, Quanterix currently holds two additional Breakthrough Device Designations: one for the Simoa® p-Tau 181 blood test as an aid in diagnostic evaluation of AD3, and another for the Simoa® neurofilament light chain (NfL) plasma test as a prognostic aid in assessing the risk of disease activity in patients diagnosed with relapsing-remitting MS (RRMS)4

Advancements in Blood-Based Biomarkers

Quanterix’s Simoa® technology has been instrumental in advancing blood-based biomarkers for Alzheimer’s research and diagnostics. With its exceptional analytical sensitivity, coupled with Quanterix’s fully automated HD-X™ Automated Immunoassay Analyzer, Simoa® empowers users to access unparalleled assay performance. This heightened sensitivity holds the potential to open doors to easier and earlier diagnosis, paving the way for novel therapeutic developments aimed at slowing or halting the progression of incurable diseases.

The advancement of biomarker research by Simoa® technology signifies a potential new frontier of discovery. Its sensitivity allows for the evaluation of biomarkers in the early stages of AD, expanding our understanding of the pathophysiology and potentially enabling innovative therapeutic development. Simoa® assays could allow researchers to detect markers that were previously undetectable, driving forward our knowledge of AD disease biology and potentially revolutionizing diagnosis, therapeutic intervention, and patient quality of life.

In clinical research, the ability to measure biomarkers in liquid biopsy samples is invaluable, as one of the biggest challenges in Alzheimer’s research is the lack of reliable blood-based biomarkers for assessing treatment efficacy. Simoa® technology enables the design of cost-effective, accessible, and less invasive clinical trials, providing researchers with insights into biomarkers more readily and frequently. This accessibility may facilitate improved patient identification, engagement, and retention in clinical trials. Additionally, blood-based biomarker detection can potentially be used to monitor disease progression5 and therapeutic efficacy6, as well as surrogate endpoints7, thus streamlining the translation of research advancements to real-world applications. Blood-based biomarker driven clinical trials, enabled by Simoa® technology, represents the future of AD clinical research. By offering an alternative to costly and invasive methods like PET scans and lumbar punctures, researchers can more easily measure blood biomarker levels in response to treatment and potentially expedite the drug development.

Future Implications

The p-Tau 217 test described in the Breakthrough Device application represents a potentially significant milestone, offering a semi-quantitative in vitro diagnostic immunoassay for measuring p-Tau 217 concentration in plasma. Proposed indications include aiding in diagnostic evaluation for patients with cognitive impairment being evaluated for Alzheimer’s disease risk, providing valuable insights when interpreted alongside other diagnostic tools. While the Breakthrough Device designation for the p-Tau 217 test is a significant step forward, it is important to note that it does not guarantee expedited FDA review or approval. However, its potential to significantly impact Alzheimer’s diagnosis and treatment cannot be overstated. As research continues to evolve and technology advances, Quanterix’s breakthrough offers a beacon of hope for millions affected by Alzheimer’s disease, promising improved accessibility, accuracy, and efficacy in diagnosis and care.

Alongside the markers granted Breakthrough Device Designation status by FDA, Quanterix offers a full library of biomarker assay kits, Homebrew Custom Assay Development, as well as Biomarker Testing and Custom Assay Development Services, all leveraging Simoa® technology.


  1. Quanterix Granted Breakthrough Device Designation from U.S. FDA for Blood-Based p-Tau 217 Test for Alzheimer’s Disease. Quanterix. Published January 30, 2024. Accessed March 26, 2024.
  2. Revised Criteria for Diagnosis and Staging of Alzheimer’s. AAIC. Accessed March 26, 2024.
  3. Quanterix granted breakthrough device designation from U.S. FDA for blood-based pTau-181 assay for Alzheimer’s disease. Quanterix. Published October 11, 2021. Accessed March 26, 2024.
  4. Quanterix granted breakthrough device designation from U.S. FDA for NfL test for multiple sclerosis. Quanterix. Published April 22, 2022. Accessed March 26, 2024.
  5. van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in early Alzheimer’s disease. N Engl J Med. 2023;388(1):9-21. doi:10.1056/NEJMoa2212948
  6. Gueorguieva I, Willis BA, Chua L, et al. Donanemab exposure and efficacy relationship using modeling in Alzheimer’s disease. Alzheimers Dement (N Y). 2023;9(2):e12404. doi:10.1002/trc2.12404
  7. FDA approves treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene. U.S. Food and Drug Administration. Published April 25, 2023. Accessed March 26, 2024.