AdvanDx lands FDA nod for 90-minute pathogen test
October 27, 2009 by MassDevice staff
The Food & Drug Administration gave 510(k) approval to the Woburn, Mass.-based diagnostics maker's test for enterococcal bloodstream pathogens.
AdvanDx won 510(k) clearance from the Food & Drug Administration for its 90-minute test to diagnose enterococcal pathogen infections in the bloodstream.
The Woburn, Mass.-based diagnostics maker said its E. faecalis/OE PNA FISH test reduces the turn-around time from 2.5 hours to 90 minutes. The test detects E. faecalis bacteria, allowing doctors to distinguish between infections with that pathogen and antibiotic-resistant cousins like E. faecium.
In August, AdvanDx drummed up an $8 million Series C funding round from a pair of its existing investors, saying it would use the cash to expand its product offering and boost international sales.
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