PNA FISH is the only FDA cleared method that provides rapid, molecular identification of Candida species direct from positive blood cultures.  Results are available in hours instead of days, and enable clinicians to optimize antifungal drug selection much earlier for patients with candidemia.  A study performed at the University of Maryland Medical Center demonstrated that PNA FISH improved time to species identification by 35 to 52 hours.  The faster results enabled clinicians to provide optimal antifungal therapy earlier and helped reduce antifungal costs by $1,800 per patient, all without adversely affecting patient outcomes.  In a separate study, Della-Latta et al. at Columbia University Medical Center demonstrated that rapid PNA FISH results led to an early switch to caspofungin, an echinocandin, for 81% of patients with C. glabrata infections treated empirically with fluconazole.  The rapid results also led to an early switch to fluconazole for 70% of patients with C. albicans infections treated empirically with caspofungin.  Based on the study results, the authors concluded that the PNA FISH test "can impact the appropriate selection of the most effective antifungal therapy, thereby making it a clinically relevant diagnostic assay."

With the introduction of the 90 minutes PNA FISH protocol, laboratories will be able to further improve turn-around times for critical results and thereby help clinicians further improve antifungal selection, care, and outcomes for patients with candidemia.

"The FDA clearances for both C. albicans PNA FISH and C. albicans/C. glabrata PNA FISH marks a major milestone for AdvanDx as it completes our transition to the 90 minute protocol for PNA FISH tests covering all four Gram-stain classes," said Thais T. Johansen, President and CEO of AdvanDx.  "Hospitals can now provide accurate, actionable species identification results for the majority of critical bloodstream pathogens in just 90 minutes, enabling clinicians to improve antimicrobial therapy and outcomes for their patients," Johansen concluded.

SOURCE AdvanDx