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510 K filed with FDA for DNA-based group B strep test.(Brief Article)
2002 OCT 3 - (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 ...
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- Press release article from: PR Newswire November 29, 2001 700+ words
...optimized for use on Cepheid's portable Smart Cycler(R) TD and its next-generation GeneXpert...new DNA tests developed for use on the Smart Cycler TD will also operate on Cepheid's...through its global partners, Cepheid's Smart Cycler(R) family of products provides researchers...
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- Press release article from: PR Newswire January 8, 2001 700+ words
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- Press release article from: PR Newswire December 14, 2000 700+ words
...with Eurogentec to market the Cepheid Smart Cycler(R) system in the life sciences research...marketing and technical support for the Smart Cycler from its headquarters in Sart Tilman...as the exclusive distributor for the Smart Cycler system in Belgium, France, Germany...
Source: HighBeam Research, 510 K filed with FDA for DNA-based group B strep test.(Brief Article)