New Test for Methicillin-Resistant Staphyloccus aureus

The test is the first MRSA test to be cleared by the U.S. Food and Drug Administration (FDA) for use directly on clinical specimens.

The test was developed by Infectio Diagnostic, Inc. (IDI, Toronto, Canada; www.infectio.com), in collaboration with Cepheid (Sunnyvale, CA, USA; www.cepheid.com). Called IDI-MRSA, the test was developed specifically for use on the Smart Cycler system of Cepheid. MRSA is one of the main causes of hospital-acquired infections, affecting thousands of patients every year. The new test will make it possible to obtain an answer within one hour, whereas the traditional culture method takes two to five days. Cepheid plans to launch the test in the United States clinical market in May, while product launch in Europe is expected later in 2004.

"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, CEO of Cepheid. The company is a leading developer, manufacturer, and marketer of fully integrated systems that enable genetic assessment when and where it is needed.





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