The Food and Drug Administration, intends to make a sole source award to CDI for iCell Cardiomyoctes. The iCell Cardiomyoctes from CDI are needed for data consistency, since preliminary tobacco cytotoxicity data has been generated from CDI pluripotent-stem cell derived cardiomyocytes from previous purchase (HHSF223201210181A). In the follow-up study, the FDA needs to use the same source of pluripotent-stem cell derived cardiomyocytes. Because this study will analyze the gene expression changes, changing the source of cardiomyocytes will cause significant noise for the final data analysis.

The iCell® Cardiomyocytes must be highly purified human cardiomyocytes derived from iPS cells through proprietary differentiation and purification protocols. The cells must express monomeric red fluorescent protein (mRFP) and/or blasticidin resistance, both of which are under the control of the alpha-myosin heavy chain (Myh6) promoter. The iCell Cardiomyocytes must be purified through antibiotic resistance under control of the Myh6 promotor such that the population of cells is greater than 95% cardiomyocytes as defined by cardiac troponin T staining or mRFP expression. iCell Cardiomyocytes must be a mixture of spontaneously electrically active atrial, nodal, and ventricular-like myocytes that possess typical electrophysiological characteristics and exhibit expected electrophysiological and biochemical responses upon exposure to exogenous agents. The cells must be a reliable source of human cardiomyocytes suitable for use in targeted drug discovery, toxicity testing, and other life science research. Each unit of the iCell Cardiomyocytes must contain at least 1.5 million plateable cardiomyoctes and orders must be able to be fulfilled in a single delivery upon request.

The NAICS Code is 541711. This procurement is made under the authority of 10 USC 2304(c) (1) - only one responsible source. This is a notice of intent to issue this solicitation on a sole source basis. This notice of intent is not a solicitation for competitive proposals. Any other firms desiring consideration must fully identify their interest and capability to provide this item, or submit a proposal within 15 days to the individual listed. A determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. The projected award date is on or about March 15, 2013.

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