NOI - Sole Source Next Gen Sequencer.doc

FDA-Sole Source-128261

Intends to make a sole source award:

The Food and Drug Administration (FDA) Center for Food Safety and Nutrition (CFSAN) requires purchasing a MiSeq System for the development of DNA-based methods for food allergens. The award will be made to:

Illumina 5200 Illumina Way San Diego, CA 92122-4616 In accordance with FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. The Center for Food Safety and Nutrition (CFSAN) requires purchasing a MiSeq System.

The MiSeq is unique in its compatibility with next generation sequencing systems already installed in FDA regulatory laboratories. The sequencing chemistry offered includes fluorescent, reversible chain terminators; with all four dNTPs added to reaction at the same time. This type of sequencing chemistry has reduced bias and fewer accuracy issues with homopolymer repeats as compared to other sequencing chemistries. In addition, library amplification includes clonal amplification by bridge PCR. This type of library amplification allows paired end sequencing in which fragments are sequenced from both ends, resulting in higher coverage, more reads, improved success with alignments and detection of alterations such as insertions or deletions.

This system will be used for the development and validation of next generation sequencing-based methods for detection of allergenic foods in complex matrices. These will be DNA-based allergen detection methods. We have had much success developing other DNA-based allergen detection methods in our laboratory using real time PCR and digital PCR, which has laid a strong foundation for further development of DNA methods. The greatest advantage of next generation sequencing over PCR-based methods is the potential to detect a large number of allergenic foods simultaneously in the same matrix. The system needs to be compatible with next generation sequencing systems already installed in FDA regulatory laboratories.

Illumina is the only manufacturer that makes the MiSeq System.

This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement within twelve (12) days after the publication of this synopsis which shall be considered by the agency. Responses received after 12 days or without the required information may not be considered. For information concerning this acquisition contact:

Tara Hobson

Contract Specialist Email: Tara.Hobson@fda.hhs.gov No phone calls please 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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