Associates of Cape Cod, Inc.

Associates of Cape Cod, Inc. is a leading company in the field of endotoxin and (1→3)-ß-D-glucans detection, with a strong focus on recombinant and traditional chromogenic and turbidimetric reagent technologies. The company, founded in 1974, has been a significant player in the biotechnology industry for 50 years, holding a pivotal role in pioneering LAL testing methodology and being the first FDA licensed company for LAL reagent manufacturing. Headquartered in Falmouth, MA, with additional facilities in the UK and the Netherlands, ACC is committed to upholding quality standards, as evidenced by its certification to I.S. EN ISO 13485:2016 and ISO 13485:2016, FDA inspection, and operation of DEA Licensed and CLIA-certified laboratories. The company's products and services cater to pharmaceutical, medical-device, biotechnology, compounding pharmacy, and dialysis industries, providing endotoxin detection reagents, instruments, and software for quality control, product release, and research purposes. Associates of Cape Cod also operates a Contract Test Services (CTS) Laboratory that specializes in endotoxin contamination testing, standing out with its GMP compliance, ISO registration, and DEA licensing. The CTS Laboratory is capable of handling various controlled drug substances and offers customized testing services aligned with FDA, USP, EP, and/or JP regulatory guidelines. Additionally, the company offers clinical diagnostics products and operates a CLIA-certified laboratory focusing on (1→3)-ß-D-glucan analysis to support the early diagnosis of Invasive Fungal Infection (IFI). ACC's diverse range of products, services, and expertise positions it as an internationally recognized leader in the field. For more information, the company's clinical diagnostics product line and CLIA-certified laboratory can be explored further through the provided LinkedIn link.