NORTHBROOK, Ill., March 18, 2010 (GLOBE NEWSWIRE) -- Nanosphere, Inc. (Nasdaq:NSPH), a leader in the development and commercialization of advanced molecular diagnostics systems, received notification from the U.S. Food and Drug Administration (FDA) that its respiratory virus panel (RVNATSP) performed on the Verigene SP System has been categorized as "Moderate Complexity" under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
The "Moderate Complexity" designation allows the test to be run in more settings by a broader group of operators.
The RVNATSP assay on the Verigene SP is the first Nanosphere test categorized as "Moderate Complexity" by the FDA. Nanosphere's previously cleared FDA products have been categorized as "High Complexity" and run on the original Verigene system. The company plans to file all of its previously cleared and future assays on the Verigene SP, which automates sample preparation, and should enable more tests to be categorized as "Moderate Complexity."
"This CLIA categorization is another validation of the value of our technology and its ease of use," said William Moffitt, Nanosphere's President and Chief Executive Officer. "It broadens our market for the Verigene SP and provides customers with the first 'Moderate Complexity' molecular flu test," Mr. Moffitt explained.
The Verigene® System is a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid and protein targets of interest for a variety of applications. The Verigene® SP System adds automated sample preparation to the original Verigene® System, allowing for sample-to-result capabilities.
About Nanosphere, Inc.
Nanosphere develops, manufactures and markets an advanced molecular diagnostics platform, the Verigene® System, for direct genomic and ultra-sensitive protein detection. This easy to use and cost effective platform enables simple, low cost and highly sensitive genomic and protein testing on a single platform. Nanosphere is based in Northbrook, IL. Additional information is available at http://www.nanosphere.us.
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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.