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AdvanDx Gets FDA Nod for Bloodstream Pathogen Test

NEW YORK (GenomeWeb News) – Molecular diagnostics company AdvanDx announced today that it has received clearance from the US Food and Drug Administration for a 90-minute version of its peptide nucleic acid fluorescence in situ hybridization (PNA FISH) test for the bloodstream pathogen Enterococcus faecalis.

AdvanDx secured FDA 510(k) clearance for the test, which is faster than the existing two-and-a-half hour E. faecalis PNA FISH test but appears to have similar sensitivity and specificity, based on clinical validation studies in the US and Europe.

In general, PNA FISH uses specific probes to target ribosomal RNA in organisms of interest, including bacteria and yeast. Compared with the 2.5 hour test, the 90-minute PNA FISH protocol has a shorter probe hybridization time of 30 minutes rather than 90 minutes.

AdvanDx says this time-savings should help labs return test results to physicians faster, potentially improving treatment and outcomes for individuals with E. faecalis and other enterococcal bloodstream infections.

Such infections are among the top hospital-acquired bacterial infections in the US and Europe. Most can be effectively treated with antibiotics such as ampicillin or vancomycin. But non-PNA FISH methods can take three days or more to identify the enterococcal infections, leading to delayed treatment and, subsequently, higher cost and mortality.

"With results in 90 minutes, hospitals will be able to provide critical results as early as possible, enabling clinicians to improve care and outcomes for patients with life-threatening infections," AdvanDx President and CEO Thais Johansen said in a statement.