Cepheid Receives FDA Clearance for GeneXpert Infinity-80 System for Initial Use with Xpert Flu Assay Industry's Highest Throughput System Capable of More Than 2,000 Daily Test Results
SUNNYVALE, Calif., May 24, 2012 /PRNewswire/ -- Cepheid (NASDAQ: CPHD) today announced that the U.S. Food & Drug Administration (FDA) has cleared its GeneXpert® Infinity-80 System, a high-throughput automated molecular system designed to deliver around-the-clock results for a wide variety of clinical testing applications. The GeneXpert Infinity-80 has been initially cleared in conjunction with Cepheid's Xpert® Flu test.
"With the capability of generating more than two thousand automated results per day, the GeneXpert Infinity-80 is the most efficient, highest throughput molecular diagnostic system on the market — delivered in the same footprint as our current Infinity-48 System," said John Bishop, Cepheid's Chief Executive Officer. "The Infinity-80 also offers a user experience that's generations ahead of alternative solutions — enabling true walk-away ease-of-use and minimal hands-on time."
The GeneXpert Infinity-80 employs the same proven, robust GeneXpert module technology used across the entire GeneXpert System family. The Infinity-80 is available in configurations of 16, 24, 32, 40, 48, 56, 64, 72, and 80 modules. In every configuration, the system is designed to adapt to any workflow requirement — on-demand, batch, or STAT testing.
The GeneXpert Infinity-80 System will be available for shipment on July 1st. Visit www.cepheid.com for more information on Cepheid's GeneXpert Systems and growing menu of Xpert tests.
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.
This press release contains forward-looking statements that are not purely historical regarding Cepheid's or its management's intentions, beliefs, expectations and strategies for the future, including those relating to future products, product performance, product availability and future market opportunities. Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from the company's current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: risks relating to the development process for new products and technologies, including unforeseen delays and costs; unforeseen supply and manufacturing problems; the ability to complete clinical trials successfully in a timely manner; uncertainties related to the regulatory review and clearance process; the potential need for additional intellectual property licenses for tests and other products and the terms of such licenses; the performance and market acceptance of any new product; sufficient customer demand; the impact of competitive products or technologies; and underlying market conditions worldwide. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K for 2011 and in its most recent quarterly report on Form 10-Q, each filed with the Securities and Exchange Commission.
All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.