ACC Announces FDA Clearance of New Fungal Infection Diagnostic Test

East Foulmouth, MA - Associates of Cape Cod, Inc. (ACC) announced that the United States Food and Drug Administration 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. ACC is a leading manufacturer of endotoxin and beta-glucan detection products and a major supplier to the pharmaceutical and medical device industries.

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® 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. A launch date for Glucatell® will be announced in the near future.

Invasive fungal infection is a serious and life-threatening medical condition. "With the addition of Glucatell® to the ACC product line, we move directly into a clinical market with a sensitive diagnostic that will expedite care to patients predisposed to invasive fungal infections," said Dr. A.J. Meuse, ACC President and CEO.

SOURCE: Associates Of Cape Cod