Associates of Cape Cod, Inc. Announces FDA Clearance of New Fungal Infection Diagnostic Test

Article

EAST FALMOUTH, Mass. -- Associates of Cape Cod, Inc.

(ACC) announce that the Food and Drug Administration (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. 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, Mass. CLIA laboratory.

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.

Associates of Cape Cod, Inc. is a leader in

the field of bacterial endotoxin and beta-glucan detection. A wholly owned

subsidiary of Seikagaku Corporation, the company pioneered the use of

Horseshoe Crab blood extract, Limulus Amebocyte Lysate (LAL), used in the

testing of pharmaceuticals, medical devices, and biologics, for the presence

of potentially toxic endotoxins and glucans. In 1977, the company was the

first to receive an FDA license for the manufacture of this reagent.

Source: Associates of Cape Cod, Inc.

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