FDA Approves AdvanDx’ Faster PNA FISH Protocol for Identifying Enterococcal Bloodstream Pathogens
Test reduces turnaround time from two and half hours to 90 minutes.
AdvanDx received FDA 510(k) clearance for a 90-minute protocol for its Enterococcus faecalis/OE PNA FISH® test. Enterococcus species cause bloodstream infections (BSI). While infections with E. faecalis are generally susceptible to ampicillin and rarely resistant to vancomycin, infections with E. faecium and other enterococci (OE) are frequently resistant to both drugs. Since conventional identification methods can take three days or longer, the company points out, up to 80% of vancomycin-resistant enterococci receive inappropriate antibiotic therapy.
AdvanDx reports that its new protocol reduces the PNA FISH turnaround time from two and half hours to 90 minutes by decreasing PNA probe hybridization from 90 minutes to 30 minutes. Clinical validation studies performed at hospitals in the U.S. and Europe demonstrated 100% equivalence between the 90-minute protocol and the original PNA FISH protocol, the company adds. E. faecalis/OE PNA FISH® is distributed by bioMerieux in the U.S.
“The faster protocol marks another milestone toward AdvanDx’ goal of providing a fast, easy-to-use, and broad molecular diagnostic platform for early identification of bloodstream pathogens,” remarks Thais T. Johansen, president and CEO. “With results in 90 minutes, hospitals will be able to provide critical results as early as possible, enabling clinicians to improve care and outcomes for patients with life-threatening infections.”