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AdvanDx wins FDA OK for speedy blood infection test

Mon, 01/17/2011 - 8:42am
Mass High Tech: The Journal of New England Technology

Woburn-based AdvanDx Inc. has won approval from the FDA for its speedy blood test for simultaneously identifying Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa infections.

The U.S. Food and Drug Administration gave 510(k) clearance for the test, which can spot the infections in positive blood cultures containing Gram-negative rods in less than 90 minutes, according to officials. The GNR Traffic LightPNA FISH test is based on AdvanDx’s molecular-based PNA FISH diagnostics platform.

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