FDA Grants Breakthrough Device Designation to pTau 217 Blood Test for Alzheimer Disease

Mikki Orso/AdobeStock

The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Spear Bio’s pTau 217 blood test for Alzheimer disease.¹

pTau 217, a phosphorylated fragment of the protein tau, is a biomarker that has shown the ability to distinguish Alzheimer disease from its other neurodegenerative disorder peers. Furthermore, it has shown strong performance compared with other biomarkers.²

The test is intended to help diagnose Alzheimer disease and potentially distinguish it from other neurological conditions. Traditional testing methods for Alzheimer disease—positron emission tomography and/or lumbar puncture for cerebrospinal fluid biomarkers—are invasive and often inaccessible due to cost. The pTau 217 plasma assay uses a “wash-free workflow building on well-established and robust real-time PCR technology as the readout method.” Importantly, it provides a convenient, accessible, and less invasive alternative for identification and/or dismissal of the presence of amyloid pathology. This will allow clinicians to diagnose Alzheimer disease earlier and more efficiently, giving them more time to slow the progression of the disease.

"Receiving FDA Breakthrough Device Designation for our pTau 217 blood test marks an important milestone for Spear Bio." said Feng Xuan, PhD, cofounder and CEO of Spear Bio. "We are dedicated to providing clinicians and patients with an affordable, accessible, and highly sensitive diagnostic solution that enables timely and accurate decision-making."

Critical to this breakthrough is Spear Bio's Successive Proximity Extension Amplification Reaction (SPEAR) technology, which employs a unique 2-factor authentication mechanism to minimize background from nonspecific interactions. This enables accurate protein biomarker measurements at concentrations as low as 1 fg/mL from just 1mL of diluted sample. Its wash-free format also allows free antigen-antibody interactions in a homogeneous solution, which maximizes binding specificity.

Spear Bio shared that this FDA Breakthrough Device Designation reinforces its next-generation approach to measuring protein biomarkers at exceptionally low concentrations and highlights the ability of SPEAR Technology to assist in neurodegenerative disease research and diagnostics, along with improving patient outcomes.

Last year, several other pTau217 biomarker tests received Breakthrough Device Designation, including the Elecsys pTau217 assay from Roche in collaboration with Eli Lilly and Company,³ and the Simoa pTau 217 blood test from Quanterix.⁴

“The incidence of dementia is growing worldwide, with 75% of cases remaining undiagnosed. Consequently, there is a critical role for diagnostics to play in addressing this global health challenge,” said Matt Sause, CEO of Roche Diagnostics. “We believe pTau 217 is going to be crucial in the diagnosis of Alzheimer disease.”³

“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 disease. The FDA’s decision to grant Breakthrough Device Designation further validates the importance of accessible, noninvasive pTau 217 testing.”⁴

References

1. Spear Bio Secures FDA Breakthrough Device Designation for its novel pTau 217 blood test, advancing scalable solutions for early Alzheimer's disease diagnosis. News release. January 13, 2025. Accessed January 14, 2025. https://www.newswise.com/articles/spear-bio-secures-fda-breakthrough-device-designation-for-its-novel-ptau-217-blood-test-advancing-scalable-solutions-for-early-alzheimer-s-disease-diagnosis/?sc=mwhr&xy=5013482

2. Janelidze S, Mattsson N, Palmqvist S, et al. Plasma P-tau181 in Alzheimer's disease: relationship to other biomarkers, differential diagnosis, neuropathology and longitudinal progression to Alzheimer's dementia. Nat Med. 2020;26(3):379-386.

3. Roche granted FDA Breakthrough Device Designation for pTau217 blood test to support earlier Alzheimer's disease diagnosis. News release. April 11, 2024. Accessed January 14, 2025. https://diagnostics.roche.com/us/en/news-listing/2024/roche-granted-fda-breakthrough-device-designation-ptau217-blood-test-support-earlier-alzheimers-disease-diagnosis.html

4. Quanterix granted Breakthrough Device Designation from U.S. FDA for blood-based p-Tau 217 test for Alzheimer’s disease. News release. March 6, 2024. Accessed January 14, 2025. https://www.quanterix.com/press-releases/quanterix-granted-breakthrough-device-designation-from-u-s-fda-for-blood-based-p-tau-217-test-for-alzheimers-disease/