NanoSomiX has developed a unique process to measure a specific panel of Alzheimer’s Disease (AD)-linked neural proteins in blood. The presence of these proteins is well-documented in the brain; however they have not been detected in blood until NanoSomiX developed a proprietary method to identify and enrich neuronal exosomes from blood plasma (see sidebar: NanoSomiX Technology Overview). This technological advance will make it possible to use a blood-based assay rather than brain imaging techniques or cerebrospinal fluid extraction to look for biomarkers indicative of AD. This development simplifies sample collection and reduces costs. It promises to be an excellent screening and predictive tool for researchers studying dementia.
Published studies (see sidebar: Publications) indicate that NanoSomiX assays have a high level of sensitivity and specificity in distinguishing previously identified patients with mild cognitive impairment (MCI) and AD from age-, gender-, and ethnicity-matched controls. In studies using longitudinal sample collection, the sensitivity of the assays demonstrated the ability to detect early development of AD in the preclinical phase up to 10 years prior to the onset of symptoms in subsequently diagnosed patients. The assays have also exhibited strong specificity in differentiating between AD and other neuro-degenerative diseases.
These early findings indicate that the blood-based neural-protein assay developed by NanoSomiX is a significant advance for those conducting AD related research and drug development. Possible uses include the ability to identify early preclinical AD cases in the effort to guide therapy, serve as a prognostic tool to detect at-risk patients, and to provide a reliable biomarker in clinical trials for stratification of patients, monitoring, end point determination, etc.
NanoSomiX is currently seeking research and business partners to further develop the technology, claims, and utility of this assay.