LI-COR Submits Active Substance Master File for IRDye 800CW to European Regulatory Authorities and Registers Drug Master File with US FDA
LINCOLN, Neb.–LI-COR Biosciences announces an Active Substance Master File (ASMF) for IRDye 800CW N-succidimidyl ester is on record with European regulatory authorities in support of a clinical trial testing a targeted agent for optical imaging-assisted surgery. In addition, a Drug Master File has been registered with the United States Food and Drug Administration in anticipation of similar clinical trials in the U.S. The dye is manufactured under GMP and is the subject of a published toxicity study.
“These are key steps toward translating near-infrared contrast agents into clinical use,” says Michael Olive, Vice President, Translational Research. “This is part of our ongoing effort to facilitate the use of IRDye 800CW-labeled imaging agents in clinical studies for intraoperative applications such as fluorescence-assisted cancer surgery.”
In preclinical studies, IRDye 800CW has been conjugated to a variety of targeted agents by a number of leading molecular imaging laboratories with the intent to translate these to clinical use.
For more information regarding licensing and supply agreements for IRDye 800CW near-infrared dye contact either Brad Roth Ph.D. at brad.roth@licor.com, 402-467-0778 or Michael Olive Ph.D. at mike.olive@licor.com, 402-467-0762. or visit www.licor.com.
About LI-COR Biosciences:
LI-COR® Biosciences is a leading manufacturer of near-infrared imaging platforms, analysis software, and IRDye® infrared dye reagents for quantitative Western Blotting, small animal imaging, and DNA fragment analysis.
LI-COR pioneered the development of near-infrared fluorescence detection systems for DNA sequencing, and today provides systems for drug discovery, protein research, small animal imaging, and undergraduate training.
LI-COR instruments for photosynthesis, carbon dioxide analysis and light measurement are recognized worldwide for standard-setting innovation in plant science research and environmental monitoring.
Founded in 1971, the privately held company is based in Lincoln, Nebraska, with subsidiaries in Germany and the United Kingdom. LI-COR systems are used in over 100 countries and are supported by a global network of distributors.
