The US Food and Drug Administration (FDA) has approved the use of Associates of Cape Cod's rapid diagnostic test in detecting invasive fungal infections (IFI).
Using patient's blood serum, the Fungitell assay detects (1,3)-b-D-glucan produced by certain fungal pathogens including Candida spp. and Aspergillus spp, as well as many opportunistic fungal pathogens.
ACC president and chief executive officer AJ Meuse said the company is ready to offer support to clinicians who are concerned about the risk of fungal infections.
"We have an FDA-cleared product, extensive research, and significant experience in clinical testing associated with the diagnosis of IFI," Meuse added.
"It is, however, important to note that the fungal organism most commonly associated with fungal meningitis in the current outbreak, Exserohilum rostratum, is currently uncharacterized relative to its contribution of (1,3)-b-D-glucan to the bloodstream."
