New MRSA test that gives results in one hour approved by FDA

Main Category: MRSA / Drug Resistance
Article Date: 02 Apr 2004 - 0:00 PDT

Cepheid (NASDAQ: CPHD) has 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™ 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™ test was developed specifically for use on Cepheid's Smart Cycler" system, which provides rapid DNA analysis. Through its agreement with IDI, Cepheid plans to launch marketing of the IDI-MRSA™ 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" 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™ test will make it possible to obtain an answer within one hour, whereas the traditional culture method takes 2 to 5 days.

For further information, please contact: John Bishop, CEO, bishop@cepheid.com, or John Sluis, CFO, sluis@cepheid.com, both of Cepheid, +1-408-541-4191; or Media, Cynthia Martin, +1-312-640-6741, cmartin@financialrelationsboard.com, or Investor/Analyst Information, Tricia Ross, +1-310-407-6540, tross@financialrelationsboard.com, both of Financial Relations Board, for Cepheid.

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