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AdvanDx Gets FDA OK for Faster Staphylococcus Dx

NEW YORK (GenomeWeb News) – Molecular diagnostics firm AdvanDx said today that it has received US Food and Drug Administration clearance for faster versions of its Staphylococcus aureus and S. aureus/coagulase-negative Staphylococci diagnostic tests.

The new versions of the tests, which use peptide nucleic acid fluorescence in situ hybridization (PNA FISH), take 90 minutes to provide results instead of 2.5 hours for conventional tests because PNA probe hybridization is reduced from 90 minutes to 30 minutes, AdvanDx said.

Since 2003, the use of PNA FISH to rapidly identify staphylococcal bloodstream pathogens has drastically improved therapy decisions and outcomes for patients with bloodstream infections by providing results in hours, instead of days, helping physicians and pharmacists optimize antibiotic therapy earlier, AdvanDx said.

The 90-minute PNA FISH protocol should enable laboratories to further improve turn-around times, thereby helping clinicians further improve antibiotic selection, care, and outcomes for patients with staphylococcal bloodstream infections, the company said.

According to AdvanDx, clinical validation studies performed at various US hospitals have demonstrated that the 90 minutes protocol demonstrates the same sensitivity and specificity as slower, conventional tests.

In October, AdvanDx received FDA clearance for a 90-minute version of its PNA FISH test for the bloodstream pathogen Enterococcus faecalis.

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