SAM_NOI_75F40123Q00267.pdf

U.S. Food & Drug Administration

NOTICE OF INTENT TO SOLE SOURCE

Design and development of next-generation targeted sequencing reagents, baits, and software for the detection and typing of Campylobacter spp. from food and environmental matrices

This synopsis is hereby issued and posted in accordance with FAR Subpart 5.2 and FAR 6.302. The purpose of this synopsis is to announce the Food and Drug Administration's intent to negotiate a Firm Fixed Price sole source award with Chapter Diagnostics, Inc. located at 1455 Adams Dr, Suite 2162, Menlo Park, CA 94025 for the project titled “Design and development of next-generation targeted sequencing reagents, baits, and software for the detection and typing of Campylobacter spp. from food and environmental matrices.”

Under the authority of FAR 6.302-1, only one responsible source and no other type of services will satisfy agency requirements. The primary objective is to develop a targeted amplicon sequencing kit for detecting and typing Campylobacter spp. on/within contaminated food and environmental samples. In addition, baits will be developed to increase sequencing sensitivity.

This acquisition is for the development (using bioinformatics) of targeted amplicon sequencing (TAS) reagents and baits for use in detecting and sequencing Campylobacter spp. for strain characterization and traceback purposes. Chapter Diagnostics developed and patented the required X1 technology used for performing targeted amplicon sequencing. The X1 technology is rapid, user-friendly, and cost efficient.

The technology employs a single-tube and single-PCR reaction method for performing amplification for TAS. This streamlines and simplifies the laboratory work involved in performing sequencing, thus providing a method with fewer steps and opportunities for user error. Other companies were identified that could design, develop, and provide targeted amplicon sequencing primers and baits (to improve sequencing sensitivity) for Campylobacter spp.; however, only Chapter Diagnostics offers the required proprietary and patented X1 technology. Without the X1 technology, the tasks would take significantly more time and would result in significantly greater costs in terms of labor and consumables. There are no other companies besides Chapter Diagnostics offer the proprietary and patented X1 technology.

Specifically, this procurement calls for the following tasks to be completed:

• Task 1 - Design, develop, and test targeted next generation sequencing reagents for Campylobacter spp. in food and environmental matrices

• Task 2 - Design, develop and test baits

• Task 3 - Deliver sequencing kit and analytical software

• Task 4 - Provide Final Report

THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS; however, responsible sources may submit a capability statement in response to the above requirement with pricing information by 11:59pm (Eastern) on Friday, June 23, 2023, to the Contract Specialist, Noah Wills, at Noah.Wills@fda.hhs.gov.

mailto:Noah.Wills@fda.hhs.gov