AdvanDx Receives FDA 510(k) Clearance for 90 Minutes Protocol for Yeast Traffic LightÃ‚® PNA FISHÃ‚®
WOBURN, Mass.and VEDBAEK, Denmark, July 29 /PRNewswire/ -- AdvanDx today announced that it has received FDA 510(k) clearance for a fast, 90 minutes protocol for its Yeast Traffic Light® PNA FISH® test. 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 excellent equivalence 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% (1). While identification of the infecting Candida species is used to guide effective antifungal therapy, conventional laboratory methods can take up to 5 days or longer (2). 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.
Yeast Traffic Light PNA FISH is the only FDA cleared method that can identify, in a single test, up to five Candida species directly from positive blood cultures i