The National Cancer Institute (NCI), Center for Cancer Research (CCR), Genetics Branch plans to procure the brand BioMark System MX Package (#BMK-PKG-MX) with Fluidigm Corporation; 7000 Shoreline Court; Suite 100; San Francisco, CA 94080-1982. This acquisition will be conducted under the procedures for acquiring commercial items authorized in FAR Part 12 and under the authority to use simplified procedures for commercial requirements as provided in FAR 13.501. The North American Industry Classification System code is 334516 and the business size standard is 500 employees. This notice is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. No faxed or emailed capability statements will be accepted. Contractor shall provide one (1) original and one (1) copy of the capability statement. Capability statements must be received in the contracting office by 11:00 AM EST, by July 30, 2009. All questions must be in writing and can be faxed or emailed to: Ashley Virts, Contract Specialist via electronic mail at [email protected] or fax to 301-402-4513. It is the vendors’ responsibility to ensure all questions have been received in the contracting office. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA). Reference: NCI-90130-AV on all correspondence. Part I: Background information and description of requirements: The Genetics Branch of the Center for Cancer Research at the National Cancer Institute is engaged in investigating genetic alteration and its effect on the development and biology of cancer. The purpose of this acquisition is to procure a BioMark System MX Package to comply with the Next-generation sequencing currently in use in the lab. While next-generation sequencing is an incredibly powerful tool, much of the genome is uninformative and therefore valuable time, labor and resources are expended fruitlessly. The Genetics Branch requires an instrument with the ability to select on more focused regions of the genome, which would allow a greater discovery rate and facilitate analysis of a greater number of samples while maximizing labor and reagent efficiencies. The BioMark System MX Package encompasses the power to control and perform the tasks needed to carry out the mission of the Genetics Lab and their study of the biology of cancer efficiently. The system with Fluidigm includes a one year software license for 20 seats; one year maintenance plan for all parts and software including technical support; installation; standard training including overview and in-depth instruction for 1.5 days for up to 5 users; 2 Integrated Fluidic (IFC) controllers (pre & post Polymerase Chain Reaction (PCR) – sample harvest capable); and access arrays to enable intersection of 48 samples with primer pairs for in-chip amplification. Following completion of PCR, amplicons are pooled in sample specific fashion. JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION: Part II: Facts and Reasons to Justify Other than Full and Open Competition: Statutory Authority Statute: This justification has been prepared under the authority of 41 U.S.C. 253 (c)(1) as set forth in 13.106-1 (b)(2) and 13.501(a)(1). (b) Soliciting from a single source. (2) For sole source acquisitions of commercial items in excess of the simplified acquisition threshold conducted pursuant to subpart 13.5, the requirements at 13.501(a) apply. No other requirement and/or type for supply or service will satisfy agency need. Justification: The BioMark System MX Package is a fully integrated system enabling of gene expression, genotyping, mutant detection, and absolute quantization nucleic-acid sequences utilizing Digital and/or Dynamic Array Integrated Fluidic (IFC) technology. Its unique “Slingshot” assay has the ability to precisely determine the concentration of amplifiable single strand molecules in a sequencing library which are appropriately adapted. Its unique access array enables the efficient Polymerase Chain Reaction (PCR) amplification and mechanical harvest of multiple amplicons across a large sample set to both enrich for regions of interest and maximize utility of next-generation sequencing. The system is solely produced by Fluidigm and the key components are patented and designed to operate as an integrated system. Therefore, no other source is known to the NCI to comply with the needs of the lab for this acquisition. The following salient characteristics apply to the BioMark System MX Package: o Flexible and user configurable (eg. non-spotted) fluidic array technology o Performs more than 9200 pair-wise reactions parallel between 96 unique samples and 96 unique assays o Utilizes fixed nanoliter volume reaction chambers which enable controlled reproducible results independent of input sample and assay volumes o Performs genetic analyses including gene expression with real time PCR reagents, genotyping (end point analysis), and digital Polymerase Chain Reaction (PCR) o Detects gene expression profiles from starting RNA material of less than 1 picogram. o Genetic analysis platform array with detection sensitivity of a single copy per chamber (reaction) o Absolute quantification of amplifiable DNA for Next Generation Sequencing libraries o Genotyping call rate of 99% or greater and call accuracy of 99.75% or greater. o Genetic analysis platform for use in gene expression with quantitative resolution of a 2-fold difference in starting copy with a 99.7% or greater confidence. o Efficient PCR amplification and mechanical harvest of 48 x 48 amplicons versus DNA templates to enrich for regions of interest o Absolute quantization nucleic-acid sequences utilizing Digital and/or Dynamic Array Integrated Fluidic (IFC) technology

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