Using nanotechnology in the device and pharmaceutical industries is such a new concept that the FDA hasn't even figured out how to regulate it yet.

But the future looks bright for nanotechnology to play a key role in improving diagnostics methods to advance a new generation of biotechnology drugs, according to Nanosphere, a Northbroook, Ill.-based life science company.

Current diagnostic systems rely on complex, expensive, lab-based technology requiring relatively large samples that run the risk of cross-contamination, the company says. Nanosphere's goal is to simplify genetic testing and make it less expensive to conduct, which should allow hospital lab technicians to use the technology rather than confining the process to specialists.

Nanosphere is currently seeking FDA approval for its Verigene System -- a device that uses nanoparticles to detect minute quantities of nucleic acids and proteins.

The technology uses ultra-sensitive protein detection methods, or "biobarcodes," to identify biomarkers -- physical traits that point to the early presence of disease. The company intends to use a recent $57 million financing deal to commercialize Verigene.

As part of its efforts to develop and market products to detect and treat difficult-to-cure diseases at their earliest stages, the company has teamed with Applied NeuroSolutions to identify new diagnostics for Alzheimer's Disease.

The collaboration combines Nanosphere's biobarcodes and Applied NeuroSolutions biomarkers, which "have been shown to be 85 to 95 percent accurate in the detection of Alzheimer's disease," according to findings published in the Annals of Neurology, Journal of Internal Medicine, American Journal of Psychiatry, and other publications.

(http://www.fdanews.com/ddl/33_22/)