SUNNYVALE, Calif., March 23 /PRNewswire-FirstCall/ -- Cepheid today announced that its collaborative partner, Infectio Diagnostic Inc. (IDI), has received clearance from the US Food and Drug Administration (FDA) to market its new IDI-MRSA(TM) test for detecting methicillin-resistant Staphylococcus aureus (MRSA). According to IDI, it is the first MRSA test cleared by the FDA for use directly on clinical specimens.
The IDI-MRSA(TM) test was developed specifically for use on Cepheid's Smart Cycler(R) system, which provides rapid DNA analysis. Through its agreement with IDI, Cepheid plans to launch marketing of the IDI-MRSA(TM) test in the United States clinical market at the American Society of Microbiology meeting scheduled for May 24, 2004 in New Orleans, Louisiana. Product launch in Europe is expected to occur in the fourth quarter of 2004.
"This represents the second in our developing pipeline of Clinical Genetic Assessment products. Running on our Smart Cycler(R) system, the speed and simplicity of IDI-MRSA test is expected to make it ideal for routine laboratory use, with rapid results helping to ensure effective management of true MRSA carriers in the hospital environment," said John Bishop, Cepheid CEO.
MRSA is one of the main causes of hospital-acquired infections affecting thousands of hospitalized patients every year. The IDI-MRSA(TM) test will make it possible to obtain an answer within one hour, whereas the traditional culture method takes 2 to 5 days.
Cepheid , based in Sunnyvale, Calif., is a leading developer, manufacturer and marketer of fully integrated systems that enable genetic assessment when and where it is needed. Founded in 1996, the company is commercializing its technology and products worldwide for research, medical, and industrial applications requiring assessment of the human genome, infectious disease and biothreat agents. See http://www.cepheid.com/ for more information.
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 product pipeline. 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: development delays; timing of regulatory clearance for new products; Cepheid's reliance on distributors to market, sell and support its products; the impact of competitive products and pricing; market acceptance of and demand for new products; and unforeseen development and manufacturing problems. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K for 2003.
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.
For further information, please contact: John Bishop, CEO, firstname.lastname@example.org, or John Sluis, CFO, email@example.com, both of Cepheid, +1-408-541-4191; or Media, Cynthia Martin, +1-312-640-6741, firstname.lastname@example.org, or Investor/Analyst Information, Tricia Ross, +1-310-407-6540, email@example.com, both of Financial Relations Board, for Cepheid.
CONTACT: John Bishop, CEO, firstname.lastname@example.org, or John Sluis, CFO,email@example.com, both of Cepheid, +1-408-541-4191; or media, Cynthia Martin,+1-312-640-6741, firstname.lastname@example.org, or investor/analystinformation, Tricia Ross, +1-310-407-6540, email@example.com,both of Financial Relations Board, for Cepheid