FDA 510(k) Clearance for AdvanDx E. coli/P. aeruginosa PNA FISH®

AdvanDx has received FDA 510(k) clearance for E. coli/P. aeruginosa PNA FISH® to identify Escherichia coli and/or Pseudomonas aeruginosa directly from positive blood cultures.

E. coli/P. aeruginosa PNA FISH is the first-ever test for identifying E. coli and P. aeruginosa directly from positive blood cultures and the latest addition to AdvanDx's easy-to-use, molecular-based PNA FISH diagnostics platform. PNA FISH tests now provide rapid species identification for the vast majority of Gram-stain results in hours instead of days, enabling therapy guiding results for 95-99% of patients with positive blood cultures.

Every year, an estimated 100,000 patients develop bloodstream infections (BSI) due to Gram-negative pathogens such as E. coli and/or P. aeruginosa. Patients afflicted by these serious infections spend an average of 5-24 days in the hospital, suffer mortality rates as high as 40% and cost institutions on average $40,000 to $60,000 per case ^1,2. These grim statistics are due in part to Gram-negative bacteria's increasing resistance to a multitude of antibiotic agents, especially in P. aeruginosa, creating complex therapy decisions for clinicians. Treatment challenges are further compounded by conventional laboratory testing methods for Gram-negative pathogens that take 24-48 hours to provide results, forcing clinicians to treat patients empirically which may not provide full coverage for the infecting pathogen.

Studies show that providing a 24 hour 'head start' on appropriate narrow-spectrum therapy for Gram-negative bloodstream infections may improve clinical outcomes, reduce antibiotic resistance rates and reduce the incidences of adverse events ^3,4. E. coli/P. aeruginosa PNA FISH will, for the first time, enable microbiology labs to provide clinicians rapid, accurate Gram-negative pathogen identification in hours, not days.

'We are very excited to launch E. coli/P. aeruginosa PNA FISH as another critical tool to help laboratories and clinicians provide faster results and improve care for patients with life threatening infections,' said Thais T. Johansen, President and CEO of AdvanDx. 'Our PNA FISH diagnostic platform now provides a complete solution by enabling rapid identification results for 95 to 99% of all patients with positive blood cultures,' Johansen concluded.

References:

1. Kang et al. Bloodstream Infections Caused by Antibiotic-Resistant Gram-Negative Bacilli: Risk Factors for Mortality and Impact of Inappropriate Initial Antimicrobial Therapy on Outcome. Antimicrobial Agent and Chemotherapy. 2005 Feb; 49:760-766


2. Paterson et al. Impact of Antibiotic Resistance in Gram-Negative Bacilli on Empirical and Definitive Antibiotic Therapy. Clinical Infectious Diseases. 2008; 47:S14-20


3. Slama et al. Gram-negative antibiotic resistance: there is a price to pay. Critical Care. 2008 May;12 Sup 4:1-9


4. Thom et al. Impact of Empiric Antimicrobial Therapy on Outcomes in Patients with Escherichia coli and Klebsiella pneumoniae Bacteremia: A Cohort Study. BMC Infectious Diseases. 2008 Sept; 8(116)