AdvanDx Receives FDA 510(k) Clearance for 90 Minutes PNA FISH® Protocol for Identifying Candida Bloodstream Pathogens

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.

Source: AdvanDx