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510 K filed with FDA for DNA-based strep test.(Abstract)
2002 OCT 10 - (NewsRx.com & NewsRx.net) -- 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 appearing within seven days after birth) with this organism account for approximately 80% of group B streptococcal infections in infants and are usually acquired by contact with the genital tract of the mother during labor and delivery.
In 1998, the incidence of disease caused by group B streptococci was 0.6 per ...
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Source: HighBeam Research, 510 K filed with FDA for DNA-based strep test.(Abstract)