FDA Clearance of New Fungal Infection Diagnostic Test
Associates of Cape Cod, Inc. have announced that the FDA has cleared Glucatell®, a serological assay that is intended for the qualitative detection of beta-glucan in the serum of patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infection and as an aid in the diagnosis of deep seated mycoses and fungemias.
Glucatell®, a serum test, measures (1,3)-beta-D-glucan, a fungal wall compound that is shed into the blood during fungal infections. Glucatell® is sensitive to a few trillionths of a gram of (1,3)-beta-D-glucan.
In a recent study, Glucatell(R) use resulted in a median of 12 days advance indication of fungal infection, as compared with conventional diagnostic procedures.
Associates of Cape Cod, Inc. will be offering Glucatell® in kit form to reference laboratories, hospital laboratories and as a service in its East Falmouth, Massachusetts CLIA laboratory.
Source: Associates of Cape Cod, Inc. View latest company information
Posted: June 14, 2004
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