LI-COR® Infrared Dye Successfully Completes Toxicity Studies
LI-COR offers IRDye® 800CW that has been manufactured under current good manufacturing practices (cGMP) and is available for conjugation to targeted biomolecules for investigational use in clinical trials . In September of 2007, LI-COR Biosciences announced the successful completion of animal toxicity studies of its IRDye 800CW infrared dye carboxylic acid using a protocol reviewed by the Food and Drug Administration. The completion of the toxicity studies was a key milestone in the development of the IRDye 800CW dye for potential clinical imaging use. The complete report was published in 2010 and is available to the public. In addition, drug master files (DMF) are on record with U.S. and European regulatory authorities.
LI-COR IRDye infrared fluorescent dyes are used for protein and cellular assays, microscopy, and in vivo molecular imaging in animals for research purposes. IRDye 800CW is cited in a wide variety of published non-clinical research for labeling nucleic acids, antibodies, proteins, and peptides where there is a need for high signal, low background imaging. With an 800 nm emission wavelength, the IRDye 800CW dye is spectrally ideal for animal imaging research.
While the IRDye 800CW dye has successfully completed toxicity studies, it has not been studied for diagnostic or therapeutic use in humans, and has not been approved by the Food and Drug Administration for this use. LI-COR is exploring options for additional studies as next steps in the Food and Drug Administration approval process leading toward clinical use.
For more information on the investigational uses of IRDye 800CW in image-guided surgery projects, please visit our Clinical Translation website.