Enterococcal Bloodstream Pathogens Identified in 90 Minutes

A new test reduced time to appropriate therapy for Enterococcal blood stream pathogens by 1.8 days and most importantly, reduced 30-day mortality rates by 42% for patients with Enterococcus faecium bacteremia.

AdvanDx (Woburn, MA, USA) has received U.S. Food and Drug Administration (FDA; Silver Spring, MD, USA) 510(k) clearance for a fast, 90 minutes protocol for its E. faecalis other Enterococci (OE) peptide nucleic acid probes fluorescence in situ hybridization (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 and Europe demonstrated 100% equivalence between the 90 minutes protocol and the original PNA FISH protocol, ensuring the faster protocol maintains the high sensitivity and specificity required versus slower, conventional methods.

Enterococcus species cause a considerable percentage of bloodstream infections (BSI), as they are the fourth most common cause of hospital-acquired bacteremia within the United States and the fifth most common in Europe. Whereas 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 ampicillin and vancomycin (VRE - vancomycin-resistant Enterococci). Conventional identification methods can take 3 days or longer, therefore up to 80% of VRE bacteremia receives inappropriate antibiotic therapy, leading to higher mortality and significant additional hospital costs.

The 90 minutes PNA FISH protocol will enable laboratories to improve workflow flexibility and results reporting turn-around times. By providing faster results, laboratories will help clinicians further improve antibiotic selection, care, and outcomes for patients with Enterococcal bloodstream infections.

AdvanDx provides advanced molecular diagnostic products for the diagnosis and treatment of life-threatening, bloodstream infections. AdvanDx's easy-to-use products provide fast and accurate results that enable improvements in patient care and help to save lives and reduce hospital costs.

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US Food and Drug Administration