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AdvanDx
AdvanDx Receives FDA 510k Clearance for GBS PNA FISH for Rapid Detection of Group B Strep from Lim Broths
May 29th, 2009
AdvanDx 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...
Source: Health Business Week (2009-05-29)
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