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