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AdvanDx Receives FDA Clearance For PNA FISH Test

E. coli/P. aeruginosa PNA FISH and EK/P. aeruginosa PNA FISH test for identifying gram-negative bloodstream pathogens

AdvanDx has received FDA 510(k) clearance for a fast, 90 minutes protocol for its E. coli/P. aeruginosa PNA FISH and EK/P. aeruginosa PNA FISH tests. 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 US demonstrated 100% equivalence between the 90 minutes protocol and the original PNA FISH protocol. It ensured that the faster protocol maintains the high sensitivity and specificity required versus slower, conventional methods, said the company.

As the first FDA cleared rapid, molecular tests for gram-negative bloodstream infections, E. coli/P. aeruginosa PNA FISH and EK/P. aeruginosa PNA FISH are new tools that enable microbiology labs to provide gram-negative species identification in hours, instead of days to help physicians and pharmacists optimize antibiotic therapy earlier.

Clinical studies have shown that delays in appropriate therapy for P. aeruginosa are associated with increased mortality rates of up to 72%. With the introduction of the 90 minutes PNA FISH protocol, laboratories will be able to further improve turn-around times for critical results and thereby help clinicians further improve pseudomonal vs. non-pseudomonal antibiotic selection for patients with gram-negative bloodstream infections, claims the company.

Thais Johansen, president and CEO of AdvanDx, said: “We are very excited to continue the speedy transition of our PNA FISH tests to the 90 minutes protocol in the US. The FDA clearances for both the E. coli/P. aeruginosa PNA FISH and EK/P. aeruginosa PNA FISH tests brings AdvanDx a step closer to providing accurate and actionable results in just 90 minutes for the most critical bloodstream pathogens.”