AdvanDx wins third FDA nod for rapid pathogen test

December 22, 2009 by MassDevice staff

AdvanDx won its third 510(k) clearance from the Food & Drug Administration for a 90-minute bloodstream pathogen diagnostics, this time for its E. coli/P. aeruginosa PNA FISH and EK/P. aeruginosa PNA FISH tests.

The federal watchdog agency already bestowed 510(k) clearances on the Woburn, Mass.-based diagnostics maker's tests for staphylococcal and enterococcal bacteria in the bloodstream. The tests cut turn-around times by an hour by reducing probe hybridization times, according to a press release.

AdvanDx said the latest approval clears its test to distinguish between Pseudomonas aeruginosa, Escherichia coli and Klebsiella pneumoniae. These Gram-negative pathogens, especially P. aeruginosa, can be difficult treat due to their resistance to antibiotics.

Earlier this month, AdvanDx won 510(k) clearance for its S. aureus PNA FISH and S. aureus/CNS PNA FISH tests for staph bacteria. In October, its E. faecalis/OE PNA FISH test for enterococcal bacteria got the green light.

AdvanDx pulled in $8 million in a Series C round in August from a pair of existing investors, SLS Venture and LD Pensions.

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