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Nanosphere Achieves CE-IVD Marks for Three Tests, Launches in Europe

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By Justin Petrone

Nanosphere this week announced that it has received CE-IVD marks for three of its array-based tests and has "commenced distribution" in several European markets.

The Northbrook, Ill.-based molecular diagnostics firm achieved CE-IVD marks for its Respiratory Virus Plus Nucleic Acid Test, its CYP 2C19 Nucleic Acid Test for clopidogrel metabolism, and its Warfarin Metabolism Nucleic Acid Test, all of which run on its Verigene platform.

The company's partners are now distributing the tests for clinical use in Italy, Portugal, Spain, Switzerland, and Turkey. Nanosphere said it expects to begin marketing the tests in most other European markets by year end. Sales and service for Nanosphere's Verigene system will be provided by its distributors, the company said.

Nanosphere's Respiratory Virus Plus Test enables rapid detection of respiratory viruses. Specifically, the test detects on a single cartridge influenza A and B; respiratory syncytial virus A and B; influenza A subtypes, including H1, H3, and 2009 H1N1; and the genetic marker H275Y, which is associated with oseltamivir resistance. Roche markets oseltamivir as Tamiflu. The US Food and Drug Administration cleared the Respiratory Virus Plus Test in 2009.

The firm's CYP 2C19 Nucleic Acid Test is used to guide anti-platelet drug therapy for patients undergoing percutaneous coronary intervention by determining whether a patient has genetic variation associated with abnormal metabolism of clopidogrel. Bristol-Myers Squibb and Sanofi-Aventis market clopidogrel under the brand name Plavix.

Nanosphere's Warfarin Metabolism Test is used to detect genetic variations associated with metabolism of the anticoagulant warfarin, sold by BMS as Coumadin. The information supplied by the test may "guide therapeutic dosing" and reduce "potentially life threatening adverse events," according to the firm. The Warfarin Metabolism received FDA clearance in 2007.

Nanosphere's Verigene platform is a benchtop molecular diagnostics workstation that uses gold nanoparticle technology to detect nucleic acid and protein targets of interest for a variety of applications. The system processes cartridges containing arrays of oligonucleotides attached to a glass substrate.

The technology was the subject of an IP dispute with Eppendorf, which had developed and sold a colorimetric-detection array system called Silverquant. In 2009, Eppendorf initiated a European Union import ban of Nanosphere's products, claiming patent infringement (BAN 12/22/2009). The dispute ended last year when Nanosphere paid Eppendorf $4 million for the rights to the technology (BAN 8/24/2010).


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