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.
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