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FDA Approves Strep Test Using Cepheid System

Nov 21, 2002

NEW YORK, Nov. 21-A test for group B streptococcus using Cepheid's Smart Cycler quantitative-PCR instrument has been approved by the U.S. Food and Drug Administration, the company said yesterday.

 

The test is designed to be used during childbirth to test mothers for the bacterium. Group B streptococcus colonization, common among pregnant women, sometimes causes serious or even fatal infections among newborn babies.

 

This test was developed by Cepheid joint venture partner Infectio Diagnostic, a Canadian firm specializing in microbial diagnostics. Cepheid says that it can generate a result in as little as 30 minutes, making it valuable for clinical use. The companies hope to have the test on the market in the United States in the first quarter of 2003,

 

Cepheid and Infectio Diagnostic launched a joint venture in May 2000 to develop new products for the rapid diagnosis of infectious disease. That partnership pairs Cepheid technology with Infectio reagents and techniques.

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