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AdvanDx Receives FDA Clearance For PNA FISH Protocol

For identifying staphylococcal bloodstream pathogens

AdvanDx has received FDA 510(k) clearance for a 90 minutes protocol for its S. aureus PNA FISH and S. aureus/CNS PNA FISH tests. The protocol reduces the PNA FISH turn-around time from the original 2.5 hours to 90 minutes by reducing PNA probe hybridisation from 90 minutes to 30 minutes.

Clinical validation studies performed at hospitals in the US demonstrated 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.

The company said that since 2003, the use of PNA FISH for identification of staphylococcal bloodstream pathogens has improved therapy decisions and outcomes for patients with bloodstream infections by providing results in hours, instead of days to help physicians and pharmacists optimise antibiotic therapy earlier.

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 antibiotic selection, care, and outcomes for patients with staphylococcal bloodstream infections.

The company claims that PNA FISH is an easy-to-use, sensitive and specific fluorescence in situ hybridisation (FISH) assay that uses PNA (peptide nucleic acid) probes to target species specific ribosomal RNA (rRNA) in live bacteria and yeast.

The properties of the non-charged, peptide backbone of PNA probes enable the use of FISH assays in complex sample matrixes, such as blood and blood cultures, and this in turn facilitates the development of simple, yet accurate tests that don’t require the sample preparation necessary for other nucleic acid technologies.

PNA FISH tests enable microbiology labs to provide rapid and accurate identification of bloodstream pathogens directly from positive blood cultures in hours instead of days. Clinical studies show that rapid identification of bloodstream pathogens using PNA FISH tests leads to more appropriate patient therapy.