4RS JOTFOC-pop-extension-final_edited_BB_Redacted.pdf

NIH researchers use Illumina instruments to perform genomics research. As a result, the NIH has numerous Illumina instruments which require the use of Illumina (brand name) reagents and consumables. Reagents and consumables are designed, produced and qualified specifically for use with the manufacturer’s sequencing/genotyping systems. Since the systems cannot operate without reagents and consumables, it is imperative that a constant supply is available. Illumina offers a variety of models of DNA sequencers for use in smaller labs, at the benchtop, and for larger projects, through centralized large-scale sequencing centers, such as the NIH Intramural Sequencing Center (NISC). The NIH Intramural Sequencing Center (NISC) is a centralized research facility for performing high-throughput, large-scale DNA sequencing and sequence analysis.

Each Illumina instrument requires the use of reagents and consumables to ensure efficient operation and the desired outcomes of the operating systems.

Reagents are chemicals and enzymes used to perform an assay or sequencing methodology. These include Library Preparation Kits, Cluster Kits, Enrichment Kits, Sequencing Kits, Custom Oligo Pools, Standard Oligo Pools and Reagent Kits. Consumables consist of Arrays, Custom Arrays, Flow Cells, and accessories, which are used in the sequencing or genotyping process. All reagents and consumables must be compatible with, and optimally perform in the Illumina manufactured systems.

The lllumina instruments require reagents and consumables to run the instruments and produce the required data. Reagents are critical to keeping the lllumina systems operating and can change frequently for various chemical/technical advances. As a result, the NIH requires the ability to select and purchase any reagent or consumable commercially available from the vendor’s catalog.

The purpose of this procurement is to supply Illumina brand name reagents and consumables to the NIH community for use in the operation of NIH-owned and leased Illumina sequencing and genotyping systems that includes 10 NovaSeq X Plus, 16 NovaSeq 6000, 49 NextSeq 1000/2000, 25 NextSeq 500/550, 66 MiSeq, 3 MiniSeq, 19 iSeq 100 and 13 iScan with a total of 201 Sequencing and Genotyping Systems. These systems are valued at over $57 million. Each of the Illumina systems requires the use of reagents and consumables to ensure efficient operation and the desired outcomes of the operating systems.

As a sole source requirement for Illumina reagents and consumables, this extension is needed in order to ensure the availability of a crucial supply of Illumina reagents and consumables required to replicate experimental procedures and protocols both published and in progress.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title.

Illumina Reagents and Consumables.

b. Project description.

The NIH and NISC have numerous Illumina MiSeq Systems, NextSeq 550 Systems and NovaSeq 6000 Systems. These are proven platforms for genetic analysis and functional genomics. Illumina’s highly parallel sequencing technology leverages clonal cluster formation and proprietary reversible terminator chemistry to give it the speed and low cost of large-scale sequencing to generate billions to trillions of bases of high-quality DNA sequence per run. lllumina sequencing technology also provides an easy-to-use protocol that does not require emulsion PCR which allows for a self-contained system that minimizes handling errors and contamination concerns, eliminating the need for clean rooms. Cartridge-based reagent delivery and on-board cluster generation are recent improvements that streamline the process and reduce errors. NIH researchers use these platforms to investigate an ever-growing variety of genomics questions. Illumina’s offering of instrument models gives individual investigators access to the technology at the benchtop and for larger projects, through centralized large-scale sequencing centers, such as NISC. All of the sequencers accept libraries constructed in the same way and with the same reagents. The NIH also has numerous Illumina BeadArray-based Genotyping Systems that inform about copy number variation, gene expression, DNA methylation, in addition to genotypes. The BeadArray technology provides a fast and inexpensive way to access large-scale genomic data.

The lllumina systems require reagents and consumables to run the instruments and produce the required data. Reagents are critical to keeping the lllumina systems operating and can change frequently for various chemical/technical advances. As a result, the NIH requires the ability to select and purchase any reagent or consumable commercially available from the vendor’s catalog.

Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D)

× Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services

Design-build Other (specify): ____________________

Type of action.

New requirement Follow-on x Other (specify): Modification to a current contract

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ x Other (specify): Non-priced modification to current IDIQ contract

Completion Form Term form

Acquisition identification number:

Contract No. 75N92020D00022, Modification No. P00003

c. Total estimated dollar value and performance/delivery period.

Total Maximum Contract Amount: $92,416,478.00 (will remain unchanged)

Period of Performance/Ordering Period:

Current: September 3, 2020 through September 2, 2025 Proposed: September 3, 2020 through March 2, 2026

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of U.S.C. 253(c)(1) as set forth in FAR 6.302-1 – Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Illumina, Inc.

5200 Illumina Way San Diego CA 92122

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Illumina, Inc. is the leading manufacturer of cutting-edge integrated systems for large-scale analysis of genetic variation and function. Their portfolio of sequencing and array-based solutions address a range of genomic complexity and throughput, enabling researchers to select the best solution for their scientific challenge. These are proven platforms for genetic analysis and functional genomics. NIH researchers use these platforms to investigate an ever-growing variety of genomics questions through approaches such as whole genome, exome, and transcriptome sequencing. These methods are valuable for diagnosing diseases, including very rare diseases, developing new therapeutic approaches for vaccination, understanding cancer progression and predicting individual treatment plans, creating genome references for humans and microbes, and discovering new pathways of disease. Illumina’s offering of instrument models gives individual investigators access to the technology at the benchtop and for larger projects, through centralized large-scale sequencing centers, such as NISC.

Illumina equipment requires the use of Illumina brand reagents and consumables. Illumina brand reagents and consumables are currently being used to run protocols on Illumina manufactured sequencing systems. This requirement is for the purchase of Illumina manufactured reagents and consumables for use in government owned, Illumina manufactured sequencing and genotyping systems.

There are other competitors in the market. However, each company manufactures its own line of equipment and reagents and consumables. All equipment and supplies are proprietary to the manufacturer. Reagents and consumables from one manufacturer cannot be used on the equipment of another manufacturer. Likewise, studies that were started on a specific brand of equipment cannot be continued on another brand of equipment.

All reagents and consumables are designed and produced specifically for use with the unique manufacturer’s sequencing system. The use of another manufacturer’s reagents and consumables in Illumina manufactured equipment would not guarantee the response or expected outcomes and would jeopardize the research results. Changing reagents and consumables would require the changing of sequencing systems which would negate the

Government’s investment of millions of dollars of equipment and would jeopardize the research results already conducted. NIH currently has 201 Illumina systems valued at over $57 million. The use of Illumina reagents and consumables are required to replicate experimental procedures and protocols both published and in progress. The NIH must continue to purchase Illumina reagents and consumables in order to avoid the introduction of new variables into the experimental results and to avoid long delays resulting from retesting of products and sequencing systems.

The Illumina reagents and consumables are proprietary to Illumina and are not manufactured by another source. There are no authorized 3rd party resellers. In addition, the use of another manufacturer's reagents and consumables would void the warranty on the current Illumina systems owned/leased by NIH.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

A Notice of Intent Synopsis to Award a Contract Modification without providing for Full or Open Competition (Including Brand-Name) was posted on SAM.gov as Number 75N92025R00033 on 4 June 2025 and closed on 18 June 2025 and FEDCONNECT as Number 75N92025R00033 on 3 June 2025 and closed on 18 June 2025 to announce the intent for this contract extension to be awarded to the incumbent contractor and to see if any outside sources were capable of performing the work. No responses were received.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

This modification will not require an increase to the total maximum amount of the contract.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted. The market research conducted consisted of: (a) reviewing mandatory acquisition sources, (b) contacting knowledgeable acquisition and program officials in Government and industry regarding market capabilities, and (c) issuing a notice of intent as described in Section 6 above. No other sources were identified that could perform the work at the quality level required in the timeframe needed.

9. Any other facts supporting the use of other than full and open competition.

None.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed an interest, in writing, in the proposed acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

Currently there are no opportunities for competition as there are currently no authorized resellers of Illumina manufactured reagents and consumables. Keeping in mind that the competitive landscape may change over the next five years, the Contracting Officer will conduct a full search for potential sources before the next contract renewal.