Infectious Disease

510 K filed with FDA for DNA-based strep test

Published in Women's Health Weekly, October 10th, 2002

Cepheid (CPHD) announced that its joint venture partner, Infectio Diagnostic (IDI), has issued a press release regarding its filing of a 510 K with the FDA for a Group B Streptococcus (GBS) test.

The test, to be marketed under the name of IDI-Strep B and run on Cepheid's Smart Cycler instrument, is intended to be used as an aid in detecting the presence of GBS in pregnant women at the time they enter labor and delivery.

According to an article appearing in The New England Journal of Medicine, "Group B streptococcus is a leading cause of sepsis, meningitis, and death among newborn infants in Western countries. Early-onset infections (those...

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Source: Women's Health Weekly (2002-10-10)

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