Sunbird Bio touts progress in blood-based Alzheimer’s test

APEX test accurately measures relevant levels of amyloid beta in blood, aligning with amyloid deposition measured in the brain by PET scans.

Diagnostics company Sunbird Bio has unveiled promising data for its APEX amyloid beta (Aβ) test, an investigational blood-based diagnostic for Alzheimer’s disease. The Cambridge, MA and Singapore-based company says its technology demonstrated efficacy in accurately differentiating between patients who tested positive or negative for Aβ on PET scans.

The APEX Aβ test offers a potential breakthrough in Alzheimer’s diagnosis by detecting very low levels of disease-specific proteins in blood with high accuracy. The Aβ protein is a key component of plaques that form in the brains of Alzheimer’s disease patients. Established methods for Aβ testing include measuring the amount of the protein in present in cerebrospinal fluid through a spinal tap or conducting a PET brain scan to identify Aβ levels from images of the brain.

Sunbird claims its APEX test would be a more cost-effective, accessible, and scalable option than PET scans. The company’s blood-based diagnostic can effectively identify Aβ proteins that aggregate in the brain and bind to extracellular vesicles (EV) crossing the blood-brain barrier. Sunbird says that EV-associated Aβ in blood is highly correlative with Aβ build-up in the brain, a critical indicator of Alzheimer’s disease.

In a recent study involving 32 patients with confirmed PET scans, Sunbird says the APEX platform was able to discriminate between patients with and without accumulation of Aβ in the brain, as identified by PET. This suggests that the APEX test accurately measures a pathologically relevant Aβ aggregate in blood circulation, aligning with the amyloid deposition measured in the brain by PET scans. Sunbird will present the new findings this week at the AD/PD conference on Alzheimer’s and Parkinson’s Disease.

“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,” said Dr Huilin Shao, founder of Sunbird Bio. “The data unveiled today 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.”

The new findings build upon earlier published data showing that the APEX blood test can provide accurate detection and clinical subtyping of Alzheimer’s disease. According to Sunbird, the APEX assay requires no sample preparation or enrichment, preserving the native state and interactions of molecular targets. Furthermore, the company says the test is adaptable to detect various nanoscale molecular targets, including emerging biomarkers that existing technologies or PET imaging cannot detect.

“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,” said John McDonough, CEO of Sunbird.

Sunbird is developing a pipeline of diagnostic tests, including protein- and blood-based tests for Aβ, tau, alpha synuclein, and other neurological disease biomarkers. The company is now seeking partnerships to conduct further clinical studies of its technology.