– The sunbird αSyn™ assay accurately classified Parkinson’s disease-positive blood samples with 81% accuracy through the direct detection of EV-bound aggregated alpha-synuclein proteins –
– With no approved blood-based diagnostics for Parkinson’s disease, the sunbird αSyn™ assay demonstrates potential to offer a reliable, non-invasive option for patients –
– Results shared at the 18th annual Clinical Trials on Alzheimer’s Disease (CTAD) international conference –
CAMBRIDGE, Mass. & SINGAPORE--(BUSINESS WIRE)--Sunbird Bio, a biotechnology company developing proprietary blood-based technologies to improve diagnosis and treatment of neurological disorders, announced new data demonstrating that the company’s blood-based sunbird αSyn™ assay accurately detected the aggregation of extracellular vesicle (EV)-bound alpha-synuclein (α-synuclein) in the brain from a simple blood draw. Results from the study were shared in an oral presentation at the Clinical Trials on Alzheimer’s Disease (CTAD) international conference taking place December 1-4, 2025, in San Diego, California.
“We continue to build strong clinical evidence for our sunbird αSyn™ assay, which has repeatedly shown accurate detection of Parkinson’s disease from a blood sample,” said Richard Batrla, M.D., Ph.D., MBA, chief medical officer of Sunbird Bio. “These latest data reinforce that detecting post-translationally modified α-synuclein in plasma may help identify patients with related neurological conditions exhibiting α-synuclein co-pathology, supporting differential diagnosis and clinical trial stratification. We look forward to continued development of this technology and advancing its validation in additional clinical studies across biomarkers.”
In this study, researchers tested the sunbird αSyn™ assay in three independent clinical feasibility cohorts:
- Cohort 1 comprised 34 early-stage Parkinson’s disease patients and 21 age-matched controls
- Cohort 2, the exploratory cohort, comprised 32 symptomatic Parkinson’s disease patients and 12 healthy individuals that were evaluated with an assay targeting an additional disease-associated sunbird αSyn™ post-translationally modified assay
- Cohort 3, the confirmatory cohort, comprised 41 symptomatic Parkinson’s disease patients and 39 age- and gender-matched healthy individuals that were evaluated with the same disease-associated sunbird αSyn™ post-translationally modified assay as Cohort 2
In each cohort, researchers evaluated the ability of Sunbird Bio’s proprietary EV-based sunbird αSyn™ assay to accurately distinguish between EV-bound and unbound soluble forms of α-synuclein in plasma.
Results show that the sunbird αSyn™ assay accurately classified Parkinson’s disease-positive samples across all cohorts with an average area under the curve (AUC) of 0.814, indicating high accuracy in disease detection. Notably, soluble (non-EV-bound) α-synuclein markers demonstrated poor results, with an AUC of 0.534. These results underscore the potential of the sunbird αSyn™ assay to enable robust, non-invasive detection of modified α-synuclein proteins that are reflective of brain pathology. These findings are not only applicable to the detection of Parkinson’s disease but could have important implications in other neurological disorders, including Alzheimer’s disease, that have common co-pathologies associated with α-synuclein aggregation.
“Currently, there are no specific blood-based tests available for Parkinson’s disease, and a diagnosis is typically made based on symptoms, medical history and physician examination,” said Vijay Parthasarathy, Ph.D., MBA, chief product and strategy officer of Sunbird Bio. “There is a pressing need for blood-based diagnostics that enable early detection, disease monitoring and therapeutic stratification in synucleinopathies, and these encouraging results highlight the potential of our technology to meet that need for physicians and patients.”
The sunbird αSyn™ diagnostic technology directly detects and measures EV-bound, aggregated proteins in blood. The company’s growing body of clinical data continues to demonstrate the potential of its diagnostic platform to provide an accurate and accessible tool for disease detection, drug development, disease monitoring and personalized treatment selection in Parkinson’s disease, Alzheimer’s disease and other neurological disorders.
About Sunbird Bio
Sunbird Bio is a biotechnology company developing proprietary blood-based diagnostic tests that provide unprecedented insights to enable earlier, more accurate diagnosis and treatment of neurological disorders. Sunbird’s innovative technologies uniquely detect the property and activity of proteins to empower researchers and clinicians with actionable information that is not available or accessible from current tests. Sunbird Bio’s unparalleled leadership in blood-based diagnostics positions the company to become a global leader in the field, addressing significant research and clinical gaps, and serving multiple, sizable markets.
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Laura Morgan
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