NEW YORK (GenomeWeb) – With the publication this week of data around its technology for the isolation and analysis of protein biomarkers in neural exosomes, startup NanoSomix is aiming to introduce a blood-based assay for Alzheimer's disease-associated biomarkers before the end of the year.
The assay, dubbed NSX Direct, will measure two phosphorylated tau isoforms, total tau, and amyloid beta 1-42 — markers that are currently measured using either brain imaging or cerebrospinal fluid extraction, NanoSomix President and CEO John Osth told GenomeWeb. It will be first made available through an early-access program in the coming months, followed by a full commercial rollout thereafter.
NanoSomix is also planning to begin offering this year a service called NSX Enrich through which it will enrich plasma samples for neural exosomes that researchers can analyze for proteins, mRNA, and other components of interest, he said.
Like NSX Direct, the enrichment service will initially be made available on a limited basis, Osth added.
NanoSomix was founded to refine and commercialize a technology originally developed by company Co-founder and University of California, San Francisco researcher Edward Goetzl that involves the capture and isolation of neural exosomes in plasma using CD171 antibodies. The exosomes are then lysed and their contents analyzed via ELISA.
In 2014, the company and collaborating academic researchers reported data showing that, with the approach, they could use exosomal levels of two phospho-tau isoforms, amyloid beta 1-42, and total tau to classify 96 percent of Alzheimer's disease patients in a cohort of 57 cases and 57 matched controls
The study also suggested the exosomal biomarkers might prove useful for identifying asymptomatic patients likely to progress to Alzheimer's disease.
In light of these promising findings, NanoSomix expects that it could eventually develop an Alzheimer's diagnostic based on its neural exosome technology, Osth said. However, doing so would require significant additional data, which the company is working to generate with collaborators. In the meantime, it is looking to get its technology onto the market with the research-use-only NSX Direct and its service offering.
He noted that while the initial NSX Direct product would be limited to the three biomarkers described in last year's publication, "the panel is going to be dynamic … [and] I anticipate that we will, on a continuing basis, add new markers" based on available data.
Osth did not specify which biomarkers may be added to the Alzheimer's disease panel, but suggested that top candidates include ones identified in a paper published this week by Goetzl and colleagues.
In that study, which appeared in Neurology, blood samples were obtained from 26 individuals with Alzheimer's disease, 20 people who were later diagnosed with the condition, and 16 individuals with frontotemporal dementia. Samples were also taken from 46 healthy controls.
Using the NanoSomix technology, the team found that exosomal levels of cathepsin D, lysosome-associated membrane protein 1 (LAMP-1), and ubiquitinylated proteins were significantly higher for Alzheimer's disease patients versus controls. Levels of heat-shock protein 70, meanwhile, were significantly lower in Alzheimer's disease patients.
Levels of cathepsin D, LAMP-1, and ubiquitinylated protein also were significantly higher for patients with Alzheimer's disease than for patients with frontotemporal dementia, and the protein levels could be used to correctly classify all of the Alzheimer's disease patients.
The findings suggest the proteins may prove to be "useful biomarkers," but need to be validated in larger studies, the paper's authors wrote.
Though focused initially on Alzheimer's disease, NanoSomix also sees potential for its technology for applications in other neurological disorders, including the diagnosis of multiple sclerosis, Osth said.
However, data the company has generated in this area are very early-stage and he declined to provide specific details about the work.