FDA Clears AdvanDx Fungal Test Speed-up | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Diagnostics test developer AdvanDx said today that it has received 510(k) clearance from the US Food and Drug Administration for a new protocol that speeds up results for two of its tests for fungal bloodstream infection.

The protocol cleared by FDA reduces the time for results for its PNA FISH tests for Candida albicans and for C. glabrata from two 2.5 hours to 90 minutes.

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