Sunbird Bio, a biotechnology company developing proprietary protein- and blood-based technologies to improve diagnosis and treatment of neurological disorders and early-stage cancer, today announced new data demonstrating that their APEX (Amplified Plasmonic EXosomes) amyloid beta (Aβ) test, the company’s investigational blood-based diagnostic in Alzheimer’s disease, effectively discriminated between patients who were positive versus negative for Aβ on positron emission tomography (PET) scans. The data will be shared this week in a poster presentation at the AD/PD™ 2024 International Conference on Alzheimer’s and Parkinson’s Disease.

“These results provide further evidence that the APEX platform has the potential to offer highly sensitive and accurate Alzheimer’s disease diagnosis equivalent to PET scans from a simple blood draw,” said John McDonough, executive chair and CEO of Sunbird Bio. “Given the growing population of individuals affected by Alzheimer’s disease and the continued emergence of new and investigational therapies, there is a tremendous need to overcome the significant limitations associated with current diagnostics, which are impeding clinical development of new therapies as well as early diagnosis of disease and monitoring of disease progression.”

PET imaging is the current standard of care in diagnosing Alzheimer’s disease; however, it is expensive, often inaccessible and not scalable. The APEX Aβ test is a blood-based diagnostic that uniquely detects very low levels of disease-specific proteins in blood with high accuracy. To date, no other platforms have demonstrated the ability to directly detect these specific Aβ proteins that aggregate in the brain and then bind to extracellular vesicles (EV) that pass through the blood-brain barrier. EV-associated Aβ in blood are highly correlative and a direct reflection of Aβ build-up in the brain, a key abnormality in Alzheimer’s disease.

In the study being shared this week, researchers prospectively collected blood samples from 32 patients with confirmed PET scans (14 Aβ− and 18 Aβ+ samples). Researchers analyzed the blood samples on the APEX platform to measure EV-associated Aβ biomarkers. The APEX platform demonstrated effective discrimination between Aβ+ and Aβ− PET status with an area under the curve (AUC) of 0.90, suggesting the APEX test measures a pathologically relevant Aβaggregate in blood circulation accurate to the amyloid deposition that PET measured in the brain.

“The data unveiled not only further validate APEX’s ability to differentiate one of the most important Alzheimer’s biomarkers, but also reinforce the potential for new avenues of exploration and innovation in other Alzheimer’s disease and neurological disorder biomarkers,” said Huilin Shao, Ph.D., founder of Sunbird Bio. “Across the globe, the rate of undetected dementia is as high as 60%, and Alzheimer’s disease is typically detected at mild-to-moderate stage with current diagnostics. We’re pleased that the expanding set of data support APEX’s potential to offer best-in-class diagnostic performance and improve outcomes for patients with multiple neurological disorders.”

The results shared at AD/PD build on previously published data that confirm the APEX blood test can provide accurate detection and clinical subtyping of Alzheimer’s disease that is equivalent to PET and may significantly improve upon all other available blood-based tests. The APEX assay requires no sample preparation or enrichment, maintaining the native state and interactions of molecular targets. Additionally, APEX can be adapted to detect a range of nanoscale molecular targets, including emerging biomarkers that cannot be detected by current technologies or PET imaging.

Sunbird Bio developed the test to overcome the limitations of PET, cerebrospinal fluid (CSF)-based tests and other diagnostics that focus on unique biomarkers or ratios. The company has an active pipeline that includes protein- and blood-based tests for Aβ, tau, alpha synuclein and other biomarkers for neurological diseases. Sunbird Bio is actively securing partnerships with biopharma companies and others to accelerate the development of its APEX platform and conduct clinical studies; use cases include longitudinal monitoring, patient stratification and target engagement.