FDA clears AdvanDx' 90 minutes protocol for C. albicans PNA FISH and C. albicans/C. glabrata PNA FISH tests

AdvanDx today announced that it has received FDA 510(k) clearance for a fast, 90 minutes protocol for its C. albicans PNA FISH® and C. albicans/C. glabrata PNA FISH® tests.  The faster protocol reduces the PNA FISH turn-around time from the original 2.5 hours to 90 minutes by reducing PNA probe hybridization from 90 minutes to 30 minutes.  Clinical validation studies performed at hospitals in the United States demonstrated 100% agreement between the 90 minutes protocol, the original PNA FISH protocol and conventional identification methods, ensuring the faster protocol maintains the very high sensitivity and specificity required versus slower, conventional methods.

Candidemia, a bloodstream infection caused by Candida species, is one of the most serious hospital acquired infections, afflicting over 24,000 patients in the U.S. every year.  Immunocompromised transplantation, oncology and AIDS patients are especially at risk for contracting the infection with mortality rates as high as 50%.  While identification of the infecting Candida species is used to guide effective antifungal therapy, conventional laboratory identification methods can take up to 5 days or longer.  Therefore, patients are often treated empirically either with fluconazole, a relatively inexpensive, generic antifungal agent, or with an echinocandin, a new class of antifungal drugs that have broad activity against Candida species but are also substantially more expensive.  As a result, patients often receive inappropriate, inadequate or sometimes unnecessarily broad therapy.

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.