Twelve hospitals will use the company's assays to screen vulnerable patients for genes from multi-drug resistant organisms.
FDA Clears AdvanDx Test for Gram-negative Bloodstream Infection
The test is the first capable of simultaneously identifying Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa directly from blood cultures containing Gram-negative rods in less than 90 minutes.
AdvanDx Secures FDA Clearance for Faster Candida Test Protocol
The US Food and Drug Administration has granted 510(K) clearance for AdvanDx's 90-minute Yeast Traffic Light PNA FISH protocol for detecting Candida yeast.
FDA Clears Faster Versions of AdvanDx Bloodstream Pathogen Tests
AdvanDx received 510(k) clearance for 90-minute versions of its Escherichia coli/Pseudomonas aeruginosa and EK/P. aeruginosa diagnostic tests.
AdvanDx Gets FDA OK for Faster Staphylococcus Dx
The new version of the peptide nucleic acid fluorescence in situ hybridization test takes 90 minutes instead of 2.5 hours for conventional tests.