FDA Clearance for Pathogen ID in 90 Mins Direct from Positive Blood Cultures
AdvanDx has received FDA 510(k) clearance for a fast, 90 minutes protocol for its E. faecalis/OE 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 very high sensitivity and specificity required versus slower, conventional methods.
Enterococcus species cause a significant percentage of bloodstream infections (BSI) as they are the fourth most common cause of hospital-acquired bacteremia within the US and the fifth most common in Europe1. 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 ampicillin and vancomycin (VRE - vancomycin-resistant enterococci). Since conventional identification methods can take 3 days or longer, up to 80% of VRE bacteremia receive inappropriate antibiotic therapy, leading to higher mortality and significant additional hospital costs2,3,4.
Since 2003, E. faecalis/OE PNA FISH has been a vital test providing species identification in hours, instead of days, allowing labs to quickly report results to physicians and pharmacists to help ensure optimal therapy for Enterococcal bloodstream infections. A recently published clinical study from the University of Maryland Medical Center demonstrated that the use of E. faecalis/OE PNA FISH reduced time to laboratory results by 2.6 days, reduced time to appropriate therapy for E. faecium by 1.8 days and most importantly, reduced 30 day mortality rates by 42% for patients with E. faecium bacteremia5.
With the introduction of the 90 minutes PNA FISH protocol, laboratories will be able to further improve workflow flexibility and results reporting turn-around times. By providing even faster results, laboratories will help clinicians further improve antibiotic selection, care, and outcomes for patients with Enterococcal bloodstream infections.
'We are very excited to launch the 90 minutes E. faecalis/OE PNA FISH protocol in the United States,' said Thais T. Johansen, President and CEO of AdvanDx. 'The faster protocol marks another milestone toward AdvanDx's goal of providing a fast, easy-to-use and broad molecular diagnostic platform for early identification of bloodstream pathogens. 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,' Johansen concluded.
1. Biedenbach et al. Diagn. Microbiol. Infect. Dis. 2004; 50: 59-69.
2. Lodise et al. Clin. Infec. Dis. 2002; 34: 922-929
3. Vergis et al. Ann. Intern. Med. 2001; 135: 484-492
4. Centers for Disease Control and Prevention (CDC). Information for the public about VRE. 5. Forrest et al. Antimicrob Agents Chemother. 2008 Oct;52(10):3558-63.
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Posted on October 27, 2009