Fast Group B Strep Test for Pregnant Women

Called IDI-Strep B, the test was designed and developed by Cepheid's joint venture partner, Infectio Diagnostic (Sainte-Foy, Canada). The Smart Cycler facilitates the speed and accuracy of the test.

Cepheid says the test is the first and currently the only test cleared by the US Food and Drug Administration (FDA) that meets the performance criteria for GBS detection recommended by the US Centers for Disease Control and Prevention (CDC). According to an article in the July 20, 2000, issue of The New England Journal of Medicine, "Group B Streptococcus is a leading cause of sepsis, meningitis, and death among newborn infants in Western countries.”

"FDA clearance of the IDI GBS test represents a significant milestone with regard to our plans to enter the clinical market with applications where rapid genetic DNA testing is particularly important,” said John Bishop, CEO of Cepheid.




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