AdvanDx Receives FDA 510(k) Clearance for GBS PNA FISH(R) for Rapid Detection of Group B Strep from ... ( Test results to establish Group B Str...)

AdvanDx Receives FDA 510(k) Clearance for GBS PNA FISH(R) for Rapid Detection of Group B Strep from Lim Broths

Date:5/15/2009

Test results to establish Group B Strep colonization of pregnant women and help clinicians guide antibiotic therapy to prevent infections in newborns

GBS PNA FISH shown to detect up to 42% more positive results than conventional culture methods (1)

WOBURN, Mass. and VEDBAEK, Denmark, May 15 /PRNewswire/ -- AdvanDx today announced it received FDA 510(k) clearance for GBS PNA FISH(R) for detection of Streptococcus agalactiae, aka Group B Strep, from turbid Lim Broths inoculated with vaginal and rectal swabs obtained from pregnant women between 35 and 37 weeks gestation. The 90 minute molecular diagnostic test enables rapid and highly sensitive detection of Group B Strep from Lim Broths to help detect colonization in pregnant women.

According to the US Centers for Disease Control and Prevention (CDC), Group B Strep is the most common cause of neonatal morbidity and mortality. Approximately 1 in 4 pregnant women are colonized with Group B Strep and can transmit the bacterium to the newborn during delivery. To prevent the transmission and subsequent infection, women are routinely screened for colonization between 35 and 37 weeks gestation, and if positive, receive antibiotics at the start of labor to eradicate the bacteria. Accurate detection of Group B Strep colonization is therefore crucial to prevent as many infections as possible.(2)

During the routine laboratory testing process, vaginal and rectal swabs from pregnant women are inoculated into selective enrichment broth, e.g. Lim Broth, and incubate overnight to stimulate the growth of Group B Strep bacteria. A sample is subsequently taken for further culture workup and identification using conventional, phenotypic methods. This process can take anywhere from 3 to 4 days, and while Lim Broth is highly sensitive and selective for Group B Strep, the subsequent workup and phenotypic identification can be time consuming and may miss
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