Nanosphere Commences European Commercial Launch

Receives CE Mark for Its Respiratory Virus, Plavix Metabolism, and Warfarin Metabolism Assays

        Print
| Source: Nanosphere, Inc.

NORTHBROOK, Ill., April 19, 2011 (GLOBE NEWSWIRE) -- Nanosphere, Inc. (Nasdaq:NSPH), a leader in the development and commercialization of advanced molecular diagnostics systems, announced today it has initiated commercial launch in Europe.

Nanosphere received CE IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices for its Respiratory Virus Plus Nucleic Acid Test, CYP 2C19 Nucleic Acid Test for Clopidogrel (Plavix®) metabolism, and its Warfarin Metabolism Nucleic Acid Test, all run on the sample-to-result Verigene® System. The CE Mark allows commercial distribution in Europe as well as in all countries recognizing the CE Mark.

"The Verigene System is the first molecular system capable of performing tests for genetic, infectious diseases and protein targets on a single sample-to-result platform," said Bill Athenson, Nanosphere's vice president of International Marketing. "This system provides physicians timely and clinically actionable diagnostic information resulting in significant clinical and economic benefits."

The company has commenced distribution in Italy, Portugal, Spain, Switzerland and Turkey. It expects to begin marketing in most other European markets by year end. Sales and service for Nanosphere's Verigene System will be provided by distribution partnerships.

About the Tests:

  • The Respiratory Virus Plus Test enables rapid detection of respiratory viruses in nearly any hospital setting. This test detects Influenza A, Influenza B, RSV A, and RSV B, as well as Influenza A subtypes, including H1, H3, 2009 H1N1 and the genetic marker H275Y, associated with Oseltamivir (Tamiflu) resistance, on a single cartridge.
     
  • The Clopidogrel Metabolism Test is used to guide the proper anti-platelet drug therapy for patients undergoing percutaneous coronary intervention by determining whether a patient has genetic variations associated with abnormal metabolism of clopidogrel, commonly known by its brand name, Plavix.
     
  • The Warfarin Metabolism Test is used to detect genetic variations associated with metabolism of warfarin anti-coagulant therapy, known by its most common brand name of Coumadin®. This information may guide therapeutic dosing thereby reducing potentially life threatening adverse events.

Nanosphere has additional tests in development designed for the Verigene System and will continue to add menu relevant for these European markets. The distribution partners Nanosphere has selected are specifically targeted to the hospital diagnostic segment of the market, allowing for access and consultation to key decision makers, in genetic, infectious disease and protein applications.

About Nanosphere, Inc.

Nanosphere develops, manufactures and markets an advanced molecular diagnostics platform, the Verigene® System, for multiplexed infectious disease, genetic, and ultra-sensitive protein testing. This easy to use platform offers laboratories a convenient, simple, and cost-effective solution for highly sensitive nucleic acid and protein testing. Nanosphere is based in Northbrook, IL. Additional information is available at http://www.nanosphere.us.

The Nanosphere, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=4344.

Except for historical information, the matters discussed in this press release are "forward-looking statements" and are subject to risks and uncertainties. Actual results could differ materially from these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the following: (i) Nanosphere's ability to develop commercially viable products; (ii) Nanosphere's ability to achieve profitability; (iii) Nanosphere's ability to produce and market its products; (iv) Nanosphere's ability to obtain regulatory approval of its products; (v) Nanosphere's ability to protect its intellectual property; (vi) competition and alternative technologies; and (vii) Nanosphere's ability to obtain additional financing, if and when necessary, to support its operations. Additional risks are discussed in the Company's current filings with the Securities and Exchange Commission. Although the Company believes the expectations reflected in such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. The forward-looking statements are made as of the date of this press release, and we undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Investors:
Nanosphere, Inc.
Roger Moody, 847-400-9021


Media:
The Torrenzano Group
Ed Orgon, 212-681-1700