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AdvanDx's 90-minute Staphylococcus tests cleared by FDA

This article was originally published in Clinica

Executive Summary

The US FDA has granted 510(k) clearance for a 90-minute protocol for AdvanDx's S aureus PNA FISH and S aureus/CNS PNA FISH tests. Both tests use fluorescence in situ hybridisation (FISH), the former to detect Staphylococcus aureus bloodstream infections, and the latter to identify coagulase-negative staphylococci (CNS). True S aureus infections can cause life-threatening problems, while blood culture contamination with CNS can lead to a false diagnosis of staphylococcal infection. These patients then receive unnecessary antibiotic treatment. The original tests took 2.5 hours to produce results – the new versions have reduced peptide nucleic acid (PNA) time from 90 to 30 minutes while maintaining high sensitivity and specificity, the Woburn, Massachusetts firm claims.

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