OXFORF NANOPORT TECHNOLOGIES NANOPORE P2 SOLO REAGENTS AND SUPPLIES
Waiver type - Procurement: Nonavailability
Agency: NATIONAL INSTITUTES OF HEALTH (7529) • Product Service Code (PSC) : 6509 | Last Modified: 08/14/2023
Procurement Summary
The following Nanopore P2 Solo Reagents and Supplies are manufactured by Oxford Nanopore Technologies in the United Kingdom. These supplies are required for ongoing experiments and are required to be used with our existing GridION sequencing instrument. The GridION is a unique instrument that is a proprietary device that require the abovementioned reagents and supplies. The required supplies are manufactured and only available from Oxford Nanopore Technologies. There are no substitutes or competitors on the market that meet the requirements. The reagents and supplies listed above are required to complete already initiated and mission critical experiments to fulfill the NIAID mission. The Nanopore P2 Solo Reagents and Supplies are required for use in supporting the research that is taking place in the Bacterial Pathogenesis and Antimicrobial Resistance Unit (BPARU) of the Laboratory of Clinical Immunology & Microbiology (LCIM). BPARU studies the mechanisms by which antimicrobial resistance emerges in the natural context of human infection, Genomic sequencing of historical clinical bacterial isolates in combination with in vitro models of adaptive evolution to characterize evolutionary pathways by which present day resistance to specific antimicrobial drug classes has evolved, the pathogenesis of gram-negative bacterial infections in patients with primary immunodeficiency diseases, Application of population genomics approaches to study in vivo adaptive evolution of bacterial infections in the context of acute and chronic infection, and Biochemical studies of bacterial metabolic adaptations that occur during infection. Missions need for the item(s) are intended to satisfy the need for: Our GridION device will operate only with the proprietary reagents and supplies listed above, for which there is no other manufacture or distributor. The experiments for other device on the market.
Waiver Rationale Summary
Conclusion: Based on the above market research findings and results from the brand name or equal request for quotes RFQ-NIAID-23-2175465 posted on SAM.gov, no domestic products that meet the requirements were available. No domestically manufactured items that meet the Government’s need that are mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities and of satisfactory quality could be identified. One company responded to the solicitation (Request for Quotes), which was posted as full and open competition with a brand name or equal requirement, both quotes were for the GridION brand instrument and accessories, no domestic offers were received. The feasibility of foregoing the requirement or providing a United States-manufactured substitute has been considered, and no substitutes were found. Authority is requested to acquire the above-described Nanopore P2 Solo Reagents and Supplies, manufactured in the United Kingdom by Oxford Nanopore Technologies for the total cost of $24,579.00. Once the approved waiver is granted, this requirement will be published, as required for acquisitions not manufactured in the United States of America, on sam.gov for a period of fifteen (15) days. This need will be competed on SAM.gov under RFQ-NIAID-23-2185243 as a brand name or equal full and open competition to provide opportunity to opportunity to distributors in the marketplace. Based on the findings detailed above, the Nanopore P2 Solo Reagents and Supplies, manufactured by Oxford Nanopore Technologies are not mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. Therefore, it is hereby determined by NIAID, consistent with FAR 25.103(b)(2), that these items are not domestically available. What were the results: No other potential alternative brands, manufacturers, or instrument could be identified that meet the brand name or equal requirement for the Nanopore P2 Solo Reagents and Supplies that are compatible with the GridION Sequencing instrument that are manufactured by Oxford Nanopore Technologies in the United Kingdom. No other instrument could be found that is compatible with the current GridION instrument. Market research and previous solicitation history revealed no evidence of equal or similar instruments that are manufactured in the United States. There were no other instruments that could be identified in the commercial marketplace through market research as being manufactured in the United States that meet the brand name or equal requirements. No domestic instruments could be identified through market research.
Yes
Yes
Consistent with Policy
DRUGS AND BIOLOGICALS, VETERINARY USE
325414 - Biological Product (except Diagnostic) Manufacturing
08/10/2023
N/A
Pre-solicitation
0 - 6 months
Individual Waiver
NATIONAL INSTITUTES OF HEALTH