FDA clears ACC's (Associates of Cape Cod's) fungal diagnostic:
This article was originally published in Clinica
Executive Summary
The US FDA has given Associates of Cape Cod (ACC) clearance to market its serological assay for the qualitative detection of beta-glucan in patients with symptoms of, or medical conditions predisposing them to, invasive fungal infection, and as an aid in the diagnosis of deep-seated mycoses and fungemias. The Glucatell test measures (1,3)-beta-D-glucan, a fungal wall compound that is shed into the blood during fungal infections. In a recent study, the test resulted in a median of 12 days advance indication of fungal infection, as compared with conventional diagnostic procedures, claims the East Falmouth, Massachusetts firm, a wholly-owned subsidiary of Seikagaku.
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