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FDA Clears AdvanDx Fungal Test Speed-up

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.

Reducing the time to identify these two hospital-acquired Candida infections, which affect more than 24,000 patients in the US each year, enables physicians to begin treating patients more swiftly with the correct course of antifungal therapy. Because a new class of antifungal drugs work broadly against Candida species but are substantially more expensive than a generic antifungal agent, a test to identify which course to take can save money and enhance treatment, the firm said.

Candidemia, the bloodstream infection caused by Candida species, can have mortality rates as high as 50 percent among patients with compromised immune systems after transplants, and those with AIDS and cancer, according to AdvanDx.

The PNA FISH test is a fluorescence in situ hybridization assay that uses peptide nucleic acid probes to target species-specific ribosomal RNA that live in bacteria and yeast.