ERP PR 1301352889_JNA_Redacted.pdf

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Research Command (NMRC), Silver Spring, MD, on behalf of the Navy to meet Navy Expeditionary Medical Research requirements and the

Naval Medical Research and Development mission.

2. Nature and/or description of the action.

The proposed action is for two V-PLEX Mouse Cytokine 19-Plex Kits, SECTOR, 5 PL (Item

No. K15255D-2) for use in the Combat Wound Infections Division of the Military Relevant

Bacterial Diseases Department at NMRC. The proposed source is Meso Scale Diagnostics LLC, 1601 Research Boulevard, Rockville, MD 20850-2600.

3. Description of Supplies or Services:

Meso Scale Discovery V-PLEX Mouse Cytokine 19-Plex Kit measures 19 mouse cytokines and chemokines, providing a comprehensive profile of immune signaling molecules. Key features include small sample volume requirements and compatible with serum, plasma, and tissue supernatants. In order to screen cytokines and chemokines for upcoming preclinical animal studies, we will require two sets of assay materials. The total cost for two sets of assay materials is $34,954.00.

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

The statutory exception permitting other than full and open competition for this acquisition is 10

U.S.C. 2304(c)(1) and FAR 6.302-1 sole source (including brand name) acquisitions or FAR

13.106-1(b)(1) soliciting from a single source.

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

Meso Scale Discovery (MSD) is the sole viable vendor for our sepsis studies, as the immunology lab we're collaborating with both uses and recommends these kits for our research. MSD's V-

PLEX Mouse Cytokine 19-Plex Kit provides unmatched sensitivity and efficiency, enabling simultaneous measurement of key metabolic and immune biomarkers critical to understanding sepsis physiopathology. Unlike other vendors, MSD's multiplexing technology allows us to measure all relevant biomarkers using a single kit rather than purchasing multiple kits to cover the same range, saving time, reducing costs, and minimizing sample use. Their low-volume, high-sensitivity assays, powered by proprietary electrochemiluminescence technology, are essential for generating reliable data from the limited and irreplaceable samples available in mouse sepsis studies. These kits are uniquely suited to the demands of our research, ensuring precise and comprehensive data collection while aligning with established workflows in our partner lab.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Meso Scale Diagnostics LLC was contacted by email and/or website to obtain an estimate for two sets of their V-PLEX Mouse Cytokine 19-Plex Kits, SECTOR, 5 PL (Item No. K15255D-2).

Meso Scale replied with an estimate for the products, and after reviewing this information and online resources, we determined that Meso Scale is the only source that can provide the desired

19-plex cytokine kit (see Sole Source Statement).

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

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made.

8. Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.

Market research was performed. Meso Scale Diagnostics LLC was contacted by email and/or website to obtain an estimate for two sets of their V-PLEX Mouse Cytokine 19-

Plex Kits, SECTOR, 5 PL (Item No. K15255D-2). Catalogs and other generally available product literature published by manufacturers, distributors, and dealers or available on-line were reviewed via Google Search.

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

Meso Scale is the sole proprietor of V-PLEX technology and the only source that can provide the desired 19-plex cytokine kit that is compatible with the outputs necessary for our partner immunology laboratory (see Sole Source Statement).

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

N/A

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

N/A

12. Point of Contact:

The point of contact at the Naval Medical Research Command, Silver Spring, MD, regarding the contents of the sole source justification are the Contracting Officers in the Material Management

Department (MMD) and can be reached by emailing usn.detrick.nmrc.mbx.mmd-contracts@health.mil.

mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical Cognizance

Name Phone Date

Title Dr. Frederic Poly, MRBD Dept Head Department/Command

Requirements Cognizance

Name Phone Date

Title

Department/Command

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

CARTER.SHAMA

I.M.1624726649

Digitally signed by

CARTER.SHAMAI.M.1624726649

Date: 2026.04.08 13:14:32

-04'00'

(301) 319-9948 4/8/2026

Contracting Officer Phone Date

POLY.FREDERIC.M.1 Digitally signed by

286953308

POLY.FREDERIC.M.1286953308

Date: 2026.04.08 12:29:55 -04'00'

301 319 3232