NMRC JA_ Signed.pdf

NMRC

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 the Naval Medical Research and Development mission.

2. Nature and/or description of the action.

The proposed action is for the purchase of Meso Scale Quickplex SQ120MM Laboratory analytical instrument to be used by the Agile Vaccine and Therapeutics (AVAT) Department at

NMRC.

The proposed source is MESO Scale Discovery (MSD) @ 1601 Research Boulevard Rockville, MD 20850

3. Description of Supplies or Services:

The Meso Scale Quickplex SQ 120MM instrument will be used as an assay reader for the AVAT Department. The AVAT Department needs an analyzer that can use pre-made and customize multiplexed plates to analyze various analytes including antibody, cytokines and other various other bio markers at a higher specificity and sensitivity compared to other available platforms such as ELISA and LUMINEX.

FY24/25 MIDRP project funds in the amount of $64,000 will be used to procure the assay reader

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 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.

Minimum essential requirements for assay reader and analyzer:

- Electrochemiluminescence detection technology for superior sensitivity and dynamic range.

- Capability to analyze high level and low-level analytes within a sample simultaneously with five logs of dynamic range, to facilitate measurement differences between stimulated and non-stimulated cells or samples.

- High sensitivity: capable of detecting as little as 100,000 molecules of analyte/sample.

- Provide high sensitivity at low limits of detection wherein Lower Limit of Detection

(LLOD) is approximately 0.05 to 1 pg/mL for specific assays.

- High multiplexing capability up to 10 individual assays per well.

- Possess customizable patterned arrays.

- Capable of reading of 22 plates/hour

- Quick plate read time (Singleplex to10-spot multiplex plates) in 2 minutes and 45 seconds.

- Equipment/instrumentation must be new and include manufacturers standard warranty.

MSD utilizes electrochemiluminescence to detect binding events on patterned arrays. There are no other technologies that enable multiplexed measurement using electrochemiluminescence for detection. And there are no other suppliers that provide an electrochemiluminescence detection system that is not reliant on beads or flow cells. The MSD® platform is unique in its method for detection as outlined below.

- Electrochemiluminescence (ECL) Detection – MSD’s ECL detection utilizes proprietary SULFO-TAG™ labels that emit light upon electrochemical stimulation initiated at the electrode surfaces of MULTI-ARRAY® and MULTI-SPOT® microplates through biomolecular interactions between the analyte and labeled reporter at the surface.

- Sample Throughput – QuickPlex SQ 120 instrument can read plates in 2 to 2.45 minutes regardless of the multiplexing level. As an illustrative example, the SQ 120 can read approximately 22 96-well, 10-spot plates (measuring 10 analytes per each well) per hour resulting in 48,000 measurement per hour.

- Non-fluidic, high-reliability instruments – All assay processing and readout steps take place in MSD’s disposable plate-based format. No sample is transferred from the plate to the instrument and hence there are no complicated fluidics that may be prone to clogging and other failures. MSD’s instrumentation has been highly praised by customers for exceptional reliability.

MSD does not utilize authorized licensed resellers/distributors of MSD products. MSD is the only authorized seller/distributor of QuickPlex SQ 120 instrument and has proprietary technology for it (Attachment A). MSD’s QuickPlex SQ120 instrument combination of electrochemiluminescence and MULTI-ARRAY technology proves unsurpassed sensitivity and multiplex functionality making it an exceptional detection system.

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

Market research was performed. The following vendors were researched online. Cambridge Scientific - requested a quote online and a representative responded through an email. But the quote was not given when the company was told that a new equipment was needed for purchase.

Cambridge Scientific is a company specializing in the sale of refurbished equipment. American Laboratory Trading – provider of premium refurbished equipment, Reuzeit – specializes in managing surplus equipment, Bimedis - a buy and sell company, and PNW Scientific – sells only used equipment (Attachment B). The market research did not yield any company that sells new QuickPlex SQ120 MM machines.

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. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the Meso Scale Discovery commercial price list and will be determined fair and reasonable.

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 conducted through online search using Google, Yahoo and MSN. Five distributors were found and all of which are selling only used MSD QuickPlex SQ 120MM.

Meso Scale Discovery is the sole manufacturer and seller of NEW QuickPlex SQ 120 MM.

Consequently, MSD is the only source that can meet the Government’s requirements.

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

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

To date, no other sources have written to express an interest.

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.

Future requirements will be synopsized in accordance with FAR 5.203.

For the reasons set forth in Paragraph 5, (contracting activity) has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, (NMRC) will assess whether competition for future requirements is feasible.

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 is Deborah M. Sharpe who may be reached at (301) 319- 6471.

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

Phone Date Eileen Villasante Department Head AVAT Department/

NMRC

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.

Phone Date

Contracting Officer

Phone Date

Contracting Officer

Technical Cognizance