FDA - Notice of Intent to Sole Source Nanostring Cassettes and Reagents - 1228458

In accordance with FAR 13.501(a)(1)(ii), Only one responsible source and no other supplies or services will satisfy agency requirements. The FDA requires the purchase and delivery of Nanostring cassettes and reagents. The project for which this contract is being issued supports a research program to evaluate the usefulness of humanized mice (HM) for regulatory purposes. The HM are created by surgical implantation of human tissue into mice that have multiple genetic mutations that block the development of the mouse immune system at a very early stage. To complete the immunogenicity studies with these humanized mice, we are evaluating the usefulness of a technology to assess the gene expression of over 500 genes simultaneously from one sample, with multiple samples processed at the same time. Nanostring cassettes provide the ability to assay over 500 genes’ expression simultaneously for a single sample. There are twelve sample wells in each cassette allowing multiple samples to be assessed at the same time. This technology provides a high sensitivity, high-throughput technique to assess gene expression that would otherwise require significantly greater investment of time and money to obtain the same information via more conventional assays. CDER is currently using the nCounter® MAX Analysis System, which is proprietary to Nanostring Technologies. The cassettes used in this system are unique to Nanostring Technologies and are not manufactured or distributed by other vendors. In addition, all validation and development work has already been completed using the nCounter® MAX Analysis System.