United States Department of Agriculture Decision to Restrict Competition under the Simplified Acquisition Threshold

Identification Number:

Rev. 3/4/26

In accordance with the Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) FAR

12.102 (a), the following documents the decision to restrict competition for this acquisition.

(1) Mission Area and Contracting Activity.

Requisition Number: 1173995

Requesting Activity Agency: ARS

Contracting Activity: Purchase of Consumable Research Reagents.

(2) Estimated Value

Period Fiscal Year Total

BASE FY26 $ 149,000

Grand Total $149,000

(3) Brief Description of Supplies or Services

The acquisition involves procuring reagents for proteomic analysis of serum samples using the Olink Reveal assay. The reagents are required to carry out quantitative analysis of protein levels in plasma and serum samples from clinical studies. The levels of specific biomarkers will be measured using the Olink Reveal Assay. Olink’s Proximity Extension Assay (PEA) technology combines specificity and scalability to enable high-throughput, multiplex protein biomarker analysis. The RAFSRU currently utilizes the Olink Signature Q100 system. Olink Reveal extends the analytes from the Target 96 assay into NGS based output. The reagents and supplies required are needed to study protein biomarkers in patient samples. Olink Proteomics part Thermo Fisher Scientific is the registered trademark holder and only known distributor of the Olink reagents. The Olink Reveal reagents are not interchangeable with other manufacturer's reagents. Original Equipment Manufacturer (OEM) products are necessary to ensure that the equipment operates properly and accurately for the outcome of the research.

1. The reagent must be compatible with the Olink assay system and be able to perform the PEA assay using dual aptamer-linked antibodies.

2. Each Reveal assay should produce quantitative protein expression information in NPX units for

~1,000 analytes (protein targets) for 88 samples using 2 ul of plasma, serum or other biospecimen.

3. The assay should be validated by Olink and be compatible with analytical pipelines developed by Olink.

(1) Suggested Source Olink Proteomics – Part of Thermo Fisher Scientific https://www.thermofisher.com/us/en/home/global/government-customers-resources.html 1 (888) 584-8929 gicsgovt@thermofisher.com frank.capriglione@olink.com https://www.thermofisher.com/us/en/home/global/government-customers-resources.html

United States Department of Agriculture Decision to Restrict Competition under the Simplified Acquisition Threshold

Identification Number:

Rev. 3/4/26

(4) Justification for Restricting Competition and the Basis for that Decision.

A. Explain the unique qualifications/characteristics of the proposed contractor or product and why no other contractor or product/service can meet the Government's need.

Olink Proteomics part Thermo Fisher Scientific is the registered trademark holder and only known distributor of the Olink reagents. The Olink Reveal reagents are not interchangeable with other manufacturer's reagents.

B. Describe market research conducted and the results or the reason why no market research was conducted.

Market research was performed using internet search. A statement of exclusivity from Olink was also received and reviewed.

Certifications & Approvals

(5) Technical / Requirements Personnel Certification I certify this requirement meets the Government’s minimum need and that the supporting data, which forms a basis for this justification, is complete and accurate.

Name : Kartik Shankar, PhD Title : Suvp. Research Chemist, Research Leader, RAFSRU

(6) Contracting Officer’s Certification I certify that the data supporting the recommended use of other than full and open competition accurate and complete to the best of my knowledge and belief. I hereby approve this justification.

Name Contracting Officer