AvanDx Gets FDA OK for PNA FISH Tests

AdvanDx has been given 510(k) clearance by the FDA for its E. coli/Pseudomonas aeruginosa and Klebsiella pneumoniae/P. aeruginosa peptide nucleic acid (PNA) FISH diagnostics. The fluorescence in situ hybridization assay has a 90-minute turnaround time, the company says. The tests are the first approved for gram-negative bloodstream infections, which affect about 100,000 patients each year.