FDA Clearance for EK/P. aeruginosa PNA FISH® Identification from Blood Cultures

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

EK/P. aeruginosa PNA FISH is the first-ever test capable of identifying E. coli and/or K. pneumoniae 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, therapy-guiding results for 95-99% of patients with bloodstream infections and positive blood cultures.


Every year, an estimated 100,000 patients develop bloodstream infections (BSI) due to Gram-negative pathogens mainly E. coli, K. pneumoniae and 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).

Studies show that providing a 24 hours '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). EK/P. aeruginosa PNA FISH will enable microbiology labs to provide clinicians rapid, accurate Gram-negative pathogen identification results in hours, instead of days.

'We are very excited to launch EK/P. aeruginosa PNA FISH and provide another critical tool to help laboratories and clinicians provide faster results and improve care for patients with these 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 bloodstream infections,' Johansen concluded.