The U.S. Food and Drug Administration (FDA) intends to negotiate and award on a sole source basis to Illumina, Inc. (Illumina) under the authority 41 U.S.C. 1903, as set forth in FAR 13.501(a)(1)(ii). This acquisition is in support of the FDA’s CBER Office of Biostatistics and Epidemiology (OBE) HIVE group. The FDA intends to procure from Illumina a server and software licenses for the DRAGEN Appliance computing system. This appliance is a computer that uses field-gate programmable array (FPGA) based technology to provide hardware acceleration for genomics analysis, including BCL conversion, mapping, alignment, sorting, duplicate marking, and haplotype variant calling. The DRAGEN Bio-IT Platform software uses the FPGA acceleration to rapidly detect variants with high sensitivity and specificity, and to analyze data from whole genomes, whole exomes, targeted panels, germline and somatic datasets, and RNA sequencing. The CBER OBE HIVE group analyzes Illumina DNA sequencing data generated by FDA researchers or submitted to FDA in regulatory applications. Data analyzed in HIVE include microbiome characterization, single cell RNA- seq, gene expression from RNA sequencing, somatic mutation detection, whole genome sequence, and targeted sequencing. Illumina is the sole provider of this hardware acceleration. There are no other vendors that can create software to be used in the DRAGEN system and provide the FPGA hardware design, accuracy, and speed. The Contractor shall provide a server and software licenses to support the DRAGEN Appliance computer system. The period of performance for this appliance is one (1) year. This notice of intent is not a request for competitive quotations. However, any firm that believes it can meet these requirements may submit a written response via email to Alicia Baltimore at the email address below by noon on August 14, 2020. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the above requirement. Information received will be considered; however, a determination by the Government not to compete the proposed acquisition based on responses to this notice is solely within the discretion of the Government. If no responses are received, the FDA will proceed with the sole source award to Illumina, Inc., 200 Illumina Way, San Diego, CA, 92122. The anticipated award date of this purchase order is on or about August 21, 2020. If you have any questions regarding this announcement, please contact Alicia Baltimore at via. email
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