1224187 - FDA - Sole Source Notice.doc

FDA-Sole Source- 1224187 Illumina NextSeq 2000 Sequencing System

The Food and Drug Administration intends to make a sole source award for a Illumina NS NextSeq 2000 High Throughput Next-Generation Sequencing System. The award will be made to:

Illumina, Inc

5200 Illumina Way

San Diego CA 92122-4616

USA

www. Illumina.com

In accordance with FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

The Division of Applied Regulatory Science (DARS) OCP/OTS/CDER is investigating nucleic acid changes in several projects across DARS. The NS 2000 model will be of crucial benefit to the FDA’s genomics laboratory and research group in DARS. The NS 2000 system will allow the FDA to adapt current SOPs for the currently installed NS 500 and scale up sequencing experiments and throughput with assured sensitivity, specificity, and the required read output for samples from much larger studies. The system will allow the FDA to sequence more than 96 independent samples at one time with up to 10 million output reads per sample on a high output cell. This output is compatible with our in-house NS 500 model, which is currently limited to testing a maximum of 40 samples per sequencing run. The system uses patterned flow cells which results in a highly flexible and scalable benchtop system that offers the highest cluster density flow cell (allowing the generation of 1 billion reads vs. 400 million on NS 500 in the High Output configuration), driving down the cost per gig abase (Gb) of the sequencing run. This NS 2000 provides increases scalability for a variety of output quantities while maintaining the same high standards of genomic and transcriptomic data quality generated by our NS 500 System. Only an Illumina model or sequence system (together with the propriety sequencing kit reagents) is compatible with the in-house NS 500 model.

This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement, which includes but may not be limited to, illustrating compatibility with the currently installed NS 500 Illumina model and capabilities of all specifications described above, within fifteen (15) days after the publication of this synopsis which shall be considered by the agency. Responses received after 15 days or without the required information may not be considered. For information concerning this acquisition contact:

Nikola Zuber Contract Specialist Nikola.Zuber@fda.hhs.gov

(301) 796 - 9671 A determination by the Government not to compete because of information received is solely within the discretion of the Government. Information received will normally be considered solely for determining whether to conduct a competitive procurement.

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