26-005169 - Notice of Intent to Sole Source.docx

PRE-SOLICITATION NON-COMPETITIVE –

Notice of Intent to Sole Source

1. SOLICITATION NUMBER: 26-005169

2. TITLE: MiSeq i100 System

3. RESPONSE DATE: May 14, 2026, at 10 A.M. Eastern Daylight Time (EDT)

4. PRIMARY POINT OF CONTACT:

Gregory Noland 301-827-3078 gregory.noland@nih.gov

I. INTRODUCTION:

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute of Aging (NIA) intends to negotiate and award a purchase order without providing for full and open competition to Illumina Inc. (San Diego, CA). The purpose of this requirement is to procure a next-generation sequencing (NGS) platform to support clinical research and the development, optimization, and validation of diagnostic assays for hepatitis viruses and other transfusion-transmitted pathogens.

II. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS NAICS Code 334516 – Analytical Laboratory Instrument Manufacturing – 1000 employees, SBA Size Standard. This acquisition is NOT set aside for small businesses.

III. REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2026-01 dated 03-13-2026.

This acquisition will be conducted using the procedures of FAR Part 13 – Simplified Acquisition Procedures and FAR Part 12 – Acquisition of Commercial Items.

IV. STATUTORY AUTHORITY

This acquisition is being conducted under the authority of FAR 13.106-1(b)(1), Soliciting from a Single Source. The total estimated value of this requirement is below the Simplified Acquisition Threshold.

V. DESCRIPTION OF REQUIREMENT:

A. PURPOSE AND OBJECTIVES:

The purpose of this requirement is to provide the NIH Clinical Center, Department of Transfusion Medicine (DTM), Infectious Diseases Section requires acquisition of a next-generation sequencing (NGS) platform to support clinical research and the development, optimization, and validation of diagnostic assays for hepatitis viruses and other transfusion-transmitted pathogens.

The required system (MiSeq i100 System) must support generation of high-quality sequencing data from clinical specimens, including viral RNA/DNA and host-derived nucleic acids. The instrument must enable applications such as targeted sequencing, viral genome sequencing, and assay development workflows necessary for evaluating test performance and refining diagnostic methods prior to implementation in a clinical testing environment.

The system must meet the following functional and operational requirements:

· High data accuracy and reproducibility to ensure reliable detection of viral variants and evaluation of assay performance

· Low- to moderate-throughput capability appropriate for assay development, pilot studies, and validation activities involving smaller sample sets

· Rapid turnaround times to support iterative testing and optimization of clinical assays

· Flexible run configurations that allow efficient processing of varying sample volumes without excess capacity

· Cost-efficient operation, including the ability to minimize per-run and per-sample costs for smaller-scale sequencing applications

· Integrated and streamlined workflows, including sequencing and data analysis within a single platform to reduce complexity and variability

· Ease of use and standardized operation, supporting reproducibility and implementation in a clinical laboratory environment

· Compatibility with established library preparation methods and existing laboratory workflows.

B. PERIOD OF PERFORMANCE:

Base Year: 06/01/2026 – 05/31/2027

C. PROJECT REQUIREMENTS:

The Vendor will submit a cost proposal/quote which will address the tasks specified in the SOW. All document deliverables must be in formats (hard copy and electronic) as specified by the customer/client - at a minimum, the formats must be in industry accepted standards (e.g., MS Word, PDF). The customer/client will complete a review of each submitted deliverable within specified working days for the date of receipt.

VI. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted, Illumina, Inc is the Original Equipment Manufacturer (OEM) of the Illumina MiSeq i100 System is uniquely qualified to meet the NIH Clinical Center, Department of Transfusion Medicine (DTM), Infectious Diseases Section’s requirements for next-generation sequencing in support of assay development, optimization, and clinical research related to hepatitis viruses. No other commercially available system provides the same combination of performance, workflow integration, and cost efficiency for small-scale sequencing applications. The Illumina MiSeq i100 System is specifically designed for lower- to moderate-throughput sequencing applications, making it well-suited for assay development and optimization activities. The system provides high-quality sequencing data with consistent performance, enabling accurate evaluation of viral mutations and assay sensitivity. Additionally, the MiSeq i100 offers cost-efficient operation for smaller-scale sequencing needs. Its run configurations are optimized for lower sample volumes, allowing the laboratory to avoid the higher per-run costs associated with larger sequencing systems when full capacity is not required. This results in more efficient use of resources during assay development and validation phases.

Finally, a review of the GSA Advantage, Dynamic Small Business Search, and previous government acquisitions returned no results that meet all of the requirements. Therefore, only ILLUMINA, INC. is capable of meeting the needs of this requirement.

The intended source is:

ILLUMINA, INC.

5200 Illumina Way San Diego, CA 92122-4616

VII. CLOSING STATEMENT

THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response.

Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity Identifier (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by the closing date and time of this announcement and must reference the solicitation number, 26-005169. Responses must be submitted electronically to Gregory Noland, Contract Specialist, gregory.noland@nih.gov.