FDA Grants Breakthrough Device Designation for Phospho-Tau 217 to Help Detect AD


The device conducts blood biomarker tests that accurately diagnose amyloid pathology and can assist in diagnosing Alzheimer disease in patients with cognitive impairment.

Health care worker observing brain scans -- Image credit: BillionPhotos.com | stock.adobe.com

Image credit: BillionPhotos.com | stock.adobe.com

The FDA granted a breakthrough device designation for phospho-Tau 217 (p-Tau 217, Simoa; Quanterix Corporation), a blood test that acts as an aid in diagnosing individuals with Alzheimer disease (AD). This designation is specifically granted to products that have the potential to offer a more effective diagnosis of diseases that are life-threatening and with an unmet medical need.1

p-Tau 217 is a top-performing biomarker for AD pathology. It is the only plasma biomarker that is appropriate for diagnosing amyloid pathology accurately, and it uses ultrasensitive assessments to enhance the clinical AD diagnostics through blood biomarker tests. Traditional testing methods, which consist of positron emission tomography (PET) or lumbar puncture for cerebrospinal fluid (CSF) biomarkers, are invasive and often inaccessible for patients, therefore, high-performing blood-based biomarker tests—such as p-Tau 217—would be a better alternative for patients.1

Proposed indications include the use of test results in patients who present cognitive impairment who are being evaluated for AD risk to aid in diagnostic evaluation; however, the test is not intended to be a stand-alone diagnostic method. The test results should be interpreted alongside other diagnostic tools to establish an accurate, final diagnosis.1

“Early detection is crucial in shaping effective care strategies and improving patient outcomes,” said Masoud Toloue, CEO of Quanterix, in a press release. “The breakthrough designation is an important step in our strategy to develop a global testing infrastructure for AD. The FDA’s decision to grant breakthrough device designation further validates the importance of accessible, non-invasive p-Tau 217 testing.”1

Previously, p-Tau 217 was clinically validated in a study that evaluated 500 participants with varying cognitive statuses, including mild cognitive impairment, subjective cognitive decline, and early AD. In addition, the validation compared the test output to amyloid status determined by CSF biomarker testing. According to the results, the p-Tau 217 test had demonstrated overall accuracy that was greater than 90%, which met the most recent requirements—at the time in which the validation trial was conducted—set by the National Institute on Aging and Alzheimer Association Revised Criteria for Diagnosis and Staging of AD.1,2

“p-Tau 217 has the potential to dramatically change the clinical workflow for diagnosing and treating [patients with AD]. High accuracy blood biomarker tests can reduce the reliance on PET and CSF testing availability and simplify the process of determining the presence of AD pathophysiology,” said Tharick Pascoal MD, PhD, neurologist and associate professor of neurology and psychiatry at the University of Pittsburgh School of Medicine, in a press release.1

Despite the test’s success rate, the investigators note that this designation does not guarantee that the review and approval process will be shortened or that an application will be provided by the FDA.1

“The p-Tau 217 test provides industry leading performance combined with a simplified workflow for the provider. The launch of [this device] is an important milestone in our efforts to build broad-based non-invasive testing for amyloid pathology. We believe that [this] technology offers the world’s only full range scalable clinical solution, overcoming the complexities and limitations of less sensitive single-plexed analog immunoassay platforms that struggle to measure this important biomarker,” said Toloue in a press release. “We will make this test available worldwide to all, in our pursuit of improving access to life changing diagnostics and treatments for the millions of individuals and their families living with AD.”2


1. Businesswire. Quanterix Granted Breakthrough Device Designation from U.S. FDA for Blood-Based p-Tau 217 Test for Alzheimer’s Disease. News release. March 4, 2024. Accessed March 6, 2024. https://www.businesswire.com/news/home/20240304898657/en
2. Quanterix. Quanterix Launches High Accuracy P-Tau 217 Blood Biomarker Test To Aid Physician Diagnosis Of Alzheimer’s Disease. News release. October 24, 2023. Accessed March 6, 2024. https://www.quanterix.com/press-releases/quanterix-launches-high-accuracy-p-tau-217-blood-biomarker-test-to-aid-physician-diagnosis-of-alzheimers-disease/
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