EAST FALMOUTH, Mass., Nov. 14, 2012 /PRNewswire/ -- The Fungitell® assay, manufactured by Associates of Cape Cod, Inc. (ACC), is a FDA-cleared, highly sensitive, rapid diagnostic test that detects (1,3)-b-D-glucan in blood serum. This assay is intended for use as a diagnostic aid in clinical situations where rapid results concerning Invasive Fungal Infection (IFI) are required; Fungitell® should be used in conjunction with other diagnostic procedures.
(1,3)-b-D-glucan is produced by common primary human fungal pathogens such as Candida spp. and Aspergillus spp., as well as many opportunistic fungal pathogens. During infection, (1,3)-b-D-glucan produced by certain fungal pathogens may be released into the bloodstream and then detected by the Fungitell® assay using patient blood serum.
"ACC is ready to offer support to clinicians who are concerned about the risk of fungal infections. We have an FDA-cleared product, extensive research, and significant experience in clinical testing associated with the diagnosis of IFI," stated Dr. AJ Meuse, ACC President and Chief Executive Officer. "It is, however, important to note that the fungal organism most commonly associated with fungal meningitis in the current outbreak, Exserohilum rostratum, is currently uncharacterized relative to its contribution of (1,3)-b-D-glucan to the bloodstream."
Associates of Cape Cod, Inc. (ACC) is one of the world's largest manufacturers of products developed to detect and quantify Gram-negative bacterial endotoxins and (1,3)-b-D-glucans. Our products are used worldwide by leading pharmaceutical and medical device companies to ensure the safety of their parenteral drugs, biological products and medical devices. ACC's goal is to provide the best products and services, as well as the best technical support and customer service, to enhance the productivity and efficiency of all customers. ACC is ISO 13485:2003 certified, its laboratories are FDA Inspected and DEA Licensed and the Beacon Diagnostics® laboratory is CLIA certified.
ACC's corporate headquarters are located in East Falmouth, Massachusetts with offices in the UK and Germany. Founded in 1974, ACC was the first to be licensed by the FDA to manufacture LAL for use as a quality control test for endotoxin detection in the pharmaceutical and medical device markets. Over the years, ACC has grown to be an internationally recognized leader in endotoxin detection, with a distribution network servicing over 80 countries.