AdvanDx's PNA FISH(TM) Test Shown to Reduce Mortality by 42% for Patients With Hospital-Acquired Enterococcus faecium Bloodstream Infections

Thursday, October 23, 2008 General News
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WOBURN, Mass., Oct. 22 AdvanDx today announced that a newmedical study demonstrated use of AdvanDx's PNA FISH(TM) test reducedmortality by 42% for patients with highly drug resistant Hospital-AcquiredEnterococcus faecium bloodstream infections (BSI's). In addition, the studydemonstrated that PNA FISH reduced the time to reporting of laboratoryidentification results for all enterococcal BSI's by 2.6 days and reduced timeto appropriate antimicrobial therapy for E. faecium BSI's by 1.8 days. Thestudy was undertaken by clinicians at the University of Maryland MedicalCenter (UMMC) in Baltimore, Maryland and published in the latest issue ofAntimicrobial Agents and Chemotherapy.(1)

Bloodstream infections due to Enterococcus bacteria, predominantlyEnterococcus faecalis and E. faecium, are often acquired while patients are inthe hospital and can lead to increased mortality, longer hospital stays andincreased healthcare costs. The infection is initially diagnosed when aculture of the patient's blood turns positive with Gram-positive cocci inpairs and chains (GPCPC), indicative of enterococci and/or streptococci.Because conventional laboratory identification methods can take 48 hours orlonger and early antimicrobial therapy is crucial to ensure positive patientoutcomes, physicians often prescribe broad-spectrum antibiotics such asvancomycin to cover the patient. However, this may lead to the administrationof inadequate or inappropriate antibiotic treatment as E. faecium is oftenresistant to both vancomycin (VRE - vancomycin-resistant enterococci) andpenicillin-based drugs such as ampicillin while E. faecalis is oftensusceptible to ampicillin. PNA FISH delivers rapid, molecular identificationof E. faecalis and other enterococci, including E. faecium, directly fromGPCPC positive blood cultures in hours instead of days. As a result,laboratories can provide faster information that enables clinicians to selecteffective antibiotic therapy sooner for patients afflicted with enterococcalbloodstream infections.(1)

The study included 224 patients with hospital-acquired enterococcalbloodstream infections; 112 patients before the PNA FISH test was implemented(Pre-PNA FISH group) and 112 after implementation (PNA FISH group). Atreatment algorithm based on the rapid PNA FISH results was developed andimplemented by the hospital's antimicrobial management team. Patients with E.faecalis by PNA FISH were to be given ampicillin, while patients with otherenterococci, including E. faecium, and at "high risk" for VRE were to be givenlinezoid, a newer anti-VRE antibiotic. At the end of the study, data oncharacteristics, therapy and outcomes between the Pre-PNA FISH and PNA FISHpatients groups were compared.(1)

"Use of PNA FISH in conjunction with a treatment algorithm led to earlieridentification of the Enterococcus species for patients with hospital-acquiredenterococcal bloodstream infections and the earlier initiation of effectiveantimicrobial therapy for patients with hospital-acquired E. faeciumbloodstream infections," said Dr. Graeme Forrest, Division of InfectiousDiseases, University of Maryland Medical Center and lead author of the study.

"We are very excited to see the results from the University of MarylandMedical Center study. Not only do they show that PNA FISH significantlyspeeds up species identification results from the lab, but also that using theresults to tailor therapy at an earlier stage in bloodstream infections cansignificantly improve patient care and outcomes," said Thais T. Johansen,President and CEO of AdvanDx. "If we extrapolate the data to the rest of thecountry, PNA FISH could help ensure that all of the 18,000 patients withhospital-acquired enterococcal bloodstream infections receive effectiveantibiotic therapy as early as possible and help save close to 2,000 lives.In essence, implementing PNA FISH and providing rapid results to clinicianscould be more beneficial than any new antibiotic to treat the infections,"Johansen added.

About Bloodstream Infections

Every year, 350,000 patients contract bloodstream infections, causing over90,000 unnecessary deaths and significant costs to the healthcare system. Theinfection is detected when a culture of the patient's blood (i.e. a bloodculture) turns positive with bacteria and yeast. Rapid and accurateidentification of the specific infecting pathogen is crucial to ensure earlyand appropriate therapy and save patient lives.


PNA FISH is an easy-to-use and highly sensitive and specific fluorescencein situ hybridization (FISH) assay that uses PNA (peptide nucleic acid) probesto target species specific ribosomal RNA (rRNA) in live bacteria and yeast.The unique properties of the non-charged, peptide backbone of PNA probesenable the use of FISH assays in exceedingly complex sample matrixes, such asblood and blood cultures, and this in turn facilitates the development of verysimple, yet very accurate tests that don't require the extensive samplepreparation necessary for other nucleic acid technologies.

PNA FISH tests enable microbiology labs to provide rapid and accurateidentification of bloodstream pathogens directly from positive blood culturesin hours instead of days. Clinical studies show that rapid identification ofbloodstream pathogens using PNA FISH tests leads to more appropriate patienttherapy that saves lives and reduces unnecessary antibiotic use, patientlength of stay and hospital costs.

About AdvanDx

AdvanDx is the world's leading provider of advanced molecular diagnosticproducts for the prevention, diagnosis and treatment of life-threatening,bacterial infections. AdvanDx's easy-to-use products provide fast and accurateresults that enable dramatic improvements in patient care and help to savelives and reduce hospital costs.

AdvanDx's products employ standard laboratory techniques and equipment toreduce startup, implementation, technician and maintenance time, whileproviding fast results without sacrificing accuracy. Major medical centers,reference labs, government institutions and community hospitals throughout theUnited States, Europe and Asia rely on AdvanDx products as integral parts oftheir medical care.Significant UMMC Study Data (Pre-PNA FISH vs. PNA FISH Groups)(1) -- More than 88% of all E. faecium were resistant to vancomycin (VRE) and 100% were resistant to ampicillin -- 84% of initial empirical antimicrobial therapy for patients with E. faecium BSI's was inadequate -- 2.6 days reduction in time to laboratory identification results in PNA FISH group -- 1.8 days reduction in time to appropriate antimicrobial therapy for E. faecium in PNA FISH group -- 42% reduction in 30-day mortality rates for patients with E. faecium in PNA FISH group -- PNA FISH Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value shown to be 100% compared to conventional methods


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