JA for Under SAT 12639526Q0066 Molecular Transport Media Tubes for HPAI redacted.pdf

United States Department of Agriculture

Decision to Restrict Competition under the Simplified Acquisition Threshold

Identification Number: 12639526Q0066

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: 1166341

Requesting Activity Agency: Animal Plant Health Inspection Service (APHIS), Veterinary Services

(VS), National Veterinary Services Laboratories (NVSL).

Contracting Activity: Animal Plant Health Inspection Service (APHIS), Marketing and Regulatory

Programs Business Services (MRPBS), Acquisition and Asset Management Division (AAMD).

(2) Estimated Value:

(3) Brief Description of Supplies or Services

The acquisition involves procuring PrimeStore®MTM LH-PS-MTM-05 1.5mL of solution in 5mL cryotubes, a critical piece of scientific equipment is a plastic, cryogenic tube containing the stabilization solution. These components inactivate pathogens, lyse cells, disrupt/lyse lipid membranes, denature proteins and enzymes, and preserve and stabilize pathogen Ribonucleic acid (RNA) and

Deoxyribonucleic acid (DNA). This product is shelf-stable for up to two years. These PS-MTM cryotubes are essential for analyzing Highly Pathogenic Avian Influenza. These tubes give the labs a

“snapshot” in time by preserving and stabilizing the DNA and RNA. This is a crucial component to effectively confirming the presence of HPAI within the sample submitted. These PS-MTM cryotubes need to be purchased to enhance the laboratory’s analytical capabilities, ensure accurate and reproducible results, and support ongoing research projects that require precise quantitative analysis to determine the strain (genetic sequencing) of HPAI to determine the origins of this disease.

(1) Suggested Sources

Government Scientific Source Inc J49CN39QTNW3

Franklin Young International Inc EDQMKDZR8L13

Longhorn Vaccines and Diagnostics LPX8MDPG73Z4

(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.

The PrimeStore®MTM LH-PS-MTM-05 1.5mL of solution in 5mL (PS-MTM) cryotube possesses unique, proprietary capabilities not available in other commercially available cryotube for Highly

Pathogenic Avian Influenza testing. The PS-MTM is the only cryotube currently on the market that has FDA Class 2 clearance for microbial nucleic acid storage and stabilization. This allows for laboratories to trust that PS-MTM provides for safer and more reliable testing. These features are essential to the Government’s ability to ensure proper classification of the sample to assess if it is positive or negative for HPAI.

PS-MTM has unique features compared to other transport media:

• Inactivation: PS-MTM fully deactivates viruses, bacteria, fungi, and Mycobacterium tuberculosis. This ensures safe sample handling and transport, significantly reducing infection risk.

• Preservation: While inactivating pathogens, PS-MTM preserves the released DNA and

RNA. It contains guanidine thiocyanate, which destroys the virus's protective coat (capsid) while maintaining nucleic acids for molecular diagnostics, sequencing, and biobanking.

• Molecular Testing: PS-MTM is optimized for molecular applications like qPCR and next-generation sequencing. It eliminates the need for live pathogen transportation, making it ideal for COVID-19 and other infectious disease testing.

• Cost-Effective: Multiple infectious disease tests can be processed from a single swab sample stored in PS-MTM, making it efficient and cost-effective.

APHIS is responsible for providing an immediate response to Highly Pathogenic Avian Influenza

(HPAI) outbreaks to contain and eradicate the disease and protect the country’s health. If HPAI is not contained it would cause considerable and irreparable financial harm to the dairy industry and the federal government. It would also impact VS’ ability to meet its mission to protect the country’s animal health. If HPAI is not addressed, it would have a large effect on the nation’s dairy supply. HPAI can strike suddenly and spread fast, is devastating for dairy industries, and is considered an animal disease emergency. For these reasons, no other brand-name product can meet the Government’s minimum technical requirements, and restricting competition to the PS-

MTM is necessary to satisfy the agency’s mission need.

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

Market research was conducted to identify potential alternative products capable of meeting the

Government’s minimum technical requirements and no alternatives were found with the required

FDA class 2 stamp of approval.

Based on this market research, the Government concluded that no other commercially available product meets the essential technical characteristics along with FDA Class 2 clearance required, and only the PrimeStore®MTM LH-PS-MTM cryotube can satisfy the agency’s minimum needs.

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.

(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.