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Oxford Nanopore Technologies GridION Device & Regents

Waiver type - Procurement: Nonavailability

Agency: NATIONAL INSTITUTES OF HEALTH (7529) • Product Service Code (PSC) : 6640 | Last Modified: 08/10/2023

Procurement Summary

The GridION sequencer, consumables, and reagents are required for use in supporting the research that is taking place in the Laboratory of Virology (LV), Virus Ecology Unit (VEU) at Rocky Mountain Lab in Hamilton, MT to conducts research involving surveillance for emerging virus pathogens and host evolution of severe pathogenic viruses such as SARS-CoV-2, Nipah, and Ebola viruses. These studies are essential for assessing the risk of zoonotic spillover from novel viruses and the emergence of new variants during ongoing epidemics and pandemics. To efficiently study virus evolution, deep and rapid sequencing of virus genomic material from experimental, clinical, and field samples is required. New instrument must be compatible with GridION software to work without current instruments. The Nanopore GridION Many deep sequencing platforms exist, but they are usually expensive, have a large footprint, require extensive training, and are time consuming to use and generate data. However, Nanopore’s GridION Mk1 sequencing platform is particularly suitable for our purposes. It provides high throughput data generation of up to 250 Gb with at least 420 bases / second in 72 hours. However, any equal brand that meet these brand name or equal requirements will satisfy the need. This instrument allows us to run at least 50-100 samples per session which is what we require for our studies. Also, GridION Mk1 provides real-time processing and analysis of data enabling rapid detection of emergent variants of viruses in real time. These rapid data will provide information on variants in circulation which is essential to public health control policy decisions. Finally, our lab uses nanopore technology and we already have reagents from this company for sequencing purposes and training on these instruments. Therefore, we need a brand name or equal Nanopore GridION Mk1 for rapid deep sequencing of lab, clinical and field samples.

Waiver Rationale Summary

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. Two companies 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 GridION Mk1 Starter pack (device + consumables and regents), manufactured in the United Kingdom by Oxford Nanopore Technologies Based on the findings detailed above, the GridION Mk1 Starter pack (device + consumables and regents), 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.

Did / Will the solicitation include one of the standard BAA provisions announcing the agency’s intention to provide a price preference for domestic end products and construction material?

Yes

Was a sources sought or Request for Information issued?

No

OMB Determination

Consistent with Policy

Product

LABORATORY EQUIPMENT AND SUPPLIES

NAICS

334516 - Analytical Laboratory Instrument Manufacturing

Date Submitted

08/04/2023

Procurement Instrument Identifier (PIID)

Solicitation ID

RFQ-NIAID-23-2175465

Procurement Stage

Post-solicitation

Expected Maximum Duration of the Proposed Waiver

0 - 6 months

Waiver Coverage

Individual Waiver

Funding Agency

NATIONAL INSTITUTES OF HEALTH