FAR 13.5 Single Source or Brand Name Justification Exceeding SAT Q0453 COsigned_Redacted.pdf

United States Department of Agriculture Sole Source (Including Brand Name) Justification under

Simplified Procedures for Certain Commercial Items (FAR 13.5) Control No. (if applicable) 1232SA25Q0453

1. Identification of the agency and the contracting activity.

Agricultural Research Service (ARS)

2. The nature and/or description of the action being approved.

The USDA proposes to award a brand-name, firm-fixed-price contract to for the acquisition of the AVITI Next Generation Sequencing (NGS) System. This procurement is being conducted using the simplified procedures authorized under FAR Part 13.5.

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

The AVITI system is a high-throughput, short-read NGS platform developed by

. It will be used to support genomics research projects by providing accurate and consistent Illumina-compatible sequencing data. The system will enhance throughput, reduce manual errors, standardize workflows across USDA locations, and support increasing sample volume demands. The estimated value of this acquisition is

4. The statutory authority permitting other than full and open competition.

41 U.S.C § 1901 – Simplified Acquisition Procedures up to $7.5 million, as authorized by FAR 13.500(a) and implemented by FAR 13.501(a).

5. Supporting rationale demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring the use of the authority.

is the sole manufacturer and distributor of the AVITI Sequencing System.

This system utilizes proprietary Avidity Sequencing technology, which is not available from any other manufacturer. The AVITI platform integrates specialized hardware, consumables, sequencing chemistry, and software developed solely by , making it a fully integrated and closed system. No other vendor is authorized or equipped to provide the AVITI system, its consumables, or service support. Given the proprietary nature of the technology and the lack of authorized resellers, only is qualified to fulfill this requirement.

6. A description of efforts made to ensure offers are solicited from as many potential sources as is practicable.

Market research confirmed that Element Biosciences is the sole source provider. Searches of authorized vendors, GSA schedules, and commercial sources identified no alternative providers or resellers offering the AVITI platform or equivalent technology.

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer has determined the anticipated price to be fair and reasonable based on independent market research, comparison with pricing of other high-throughput NGS systems, and an evaluation of the proposed cost in relation to the system’s proprietary capabilities and intended use.

8. A description of the market research conducted and the results or a statement of the reason Market Research was not conducted.

Market research included a review of GSA Advantage, online vendor listings, and outreach to industry contacts. No comparable sequencing system using Avidity Sequencing™ technology was found. All evidence confirms that the AVITI system and its associated consumables and service contracts are only available through .

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

holds exclusive rights to all AVITI technology and components. No authorized resellers exist, and no alternative platform offers the same integration, chemistry, and data fidelity necessary to meet the USDA's sequencing standardization requirements.

10. A listing of the sources, if any, that expressed a written interest in the acquisition.

NA

11. A statement of actions, if any, the agency may take to remove or overcome any barriers to competition if subsequent acquisitions are anticipated.

NA

Certifications & Approvals

Supporting data which form the basis for and included in this justification are certified accurate and complete.

Perot Saelao Acting-Research Leader, VPGRU

The information contained in this Justification for Other Than Full and Open Competition is certified accurate and complete to the best of my knowledge and belief.

Nicole McKenzie Contracting Officer

Digitally signed by Nicole McKenzie Date: 2025.08.13 08:29:30 -05'00'