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US FDA grants Nanosphere clearance for first genetic test

Wednesday, 19th September 2007 (3193 views)

The US Food and Drug Administration (FDA) has granted clearance for the Nanosphere-developed Verigene System, a nanotechnology-based protein and nucleic acid diagnostics workstation.

The Verigene System, designed to be user-friendly, utilises gold nanoparticle technology to locate nucleic acid targets in the human body.

Nanosphere has also announced that the FDA has approved the first tests of the Verigene System, which clears the nanotechnology-based medical diagnostics platform for clinical use.

This approval marks the first time that the FDA has cleared a test that aims to determine the metabolism of the blood-thinning drug warfarin, which is commonly used in hospitals in North America and Europe under the brand name Coumadin.

Nanosphere now plans to develop clinical tests using the gold nanoparticle probe technology to investigate the how the effects of DNA sequence variations change the body's metabolism of specific drugs.

According to Nanosphere, the technology can also be used to identify individuals who are at risk of an inherited genetic disorder, such as cystic fibrosis, or to identify their risk of passing on a disorder to future offspring.

 

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