AdvanDx launches rapid three-pathogen test

AdvanDx logo

Traffic lights have three colors and so does an infectious disease test made by AdvanDx.

The Woburn, Mass.-based molecular diagnostics developer launched its "Traffic Light PNA FISH" test in the European Union.

The tri-color test employs "fluorescence in situ hybridization" using "peptide nucleic acid" probes, hence PNA FISH, to simultaneously determine whether an individual’s blood has the presence of gram-negative E. coli, K. pneumoniae and P. aeruginosa microbes, all of which are very dangerous if left unchecked.

PNA FISH provides results in less than 90 minutes, which is 24-48 hours sooner than conventional methods, according to a press release. Gram-negative bacteria, like methicillin-resistant Staphylococcus aureus, have been making headlines for their prevalence in bloodstream infections patients develop in hospitals after medical procedures. The GN pathogens have a certain cell structure that makes them less susceptible to to antibiotics; they must be identified quickly in order to improve outcomes for infected patients.

According to the New England Journal of Medicine, a Centers for Disease Control study estimated that 1.7 million hospital-acquired infections occurred in 2002 and almost 99,000 deaths resulted from or were associated with a hospital-acquired infection, while similar statistics have come out of European studies.

The Traffic Light is the latest product to come out of AdvanDx‘s molecular-based PNA FISH diagnostics platform. The Food & Drug Administration green-lighted the company’s test for E. faecalis/OE in October 2009 and in December 2009 granted 510(k)s for AdvanDx’s S. aureus PNA FISH and S. aureus/CNS, E. coli/P. aeruginosa and EK/P. aeruginosa tests.

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