Meso Scale Diagnostic; Biological Agent Detecting Kits

Abbreviated Justification and Approval Document
FOR OTHER THAN FULL AND OPEN COMPETITION
Of Requirements Not Exceeding $550,000 (IAW FAR 6.304)

ABERDEEN INSTALLATION CONTRACTING DIVISION

1. Contracting Activity: Army Contracting Command - Aberdeen Proving Ground (ACC-APG) Tenant Division located at Bldg. 6001 Combat Drive, Aberdeen Proving Ground (APG), MD 21005-3013

2. Description of Action:

Requirement: 1 Repeat
Pricing: X Firm-Fixed Price 0 Time & Materials 0 Cost
Funds: 0 OMA X Other Funds:

Name of Proposed Contractor: Meso Scale Diagnostics, LLC (AKA; Meso Scale Defense)
Street Address: 1601 Research Boulevard
City, State, Zip: Rockville, MD 20850-3173
Phone:
Cage Code: 240-314-2795
1ZHK4

3. Description of Supplies:

The United States Research, Development and Engineering Command (RDECOM) Edgewood Chemical Biological Center (ECBC); Environmental BioMonitoring Laboratory (EBML) has a requirement for Meso Scale Defense (MSD) custom biological kits for twelve (12) target agents: Bacillus anthracis, Francisella tularensis, Yersinia pestis, Vaccinia virus, Brucella sp., Coxiella burnetti, Staphylococcal enterotoxin B, Ebola virus, Botulinum A/B toxin, Ricin, Abrin, Venezuelan Equine Encephalitis (VEE), Shiga-like toxin 1 and Shiga-like toxin 2. The items contained in this purchase request are assays that when analyzed on specialized equipment, are used for the detection of biological agents. The kits contain assay plates in a 96 well format. Each well contains 9 "spots": one or two contain antibody against a specific agent (capture antibody), one serves as a negative control, and one as a positive control. Liquid reagents included in the kit are:

1. Detector antibody, positive control antibody, positive control antigen, and antibody diluent which are combined to form a "working stock".

2. Read buffer which is used to activate the chemical reaction that occurs as a result of the working stock interaction with the plate and the sample being tested.

4. Authority Cited:

Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5 and Class Deviation - 2015-O00004 due to only one responsible source available and capable of fulfilling the requirements. Justification in accordance with FAR 6.302-1(a)(1) citation: 10 U.S.C. 2304(c)(1) and FAR 6.302-1(a)(2), "when the supplies or services required by the agency are available from only one responsible source, or, for DoD, NASA, and the Coast Guard, form only one or a limited number of responsible sources, and no other type of supplies or services will satisfy agency requirements, full and open competition need not be provided for."

5. Reason for Authority Cited:

Meso Scale Defense is a division of Meso Scale Diagnostics, LLC. Meso Scale Defense is the manufacturer of the MSD custom biological kits for target agents (bacteria, viruses and toxins). They do not have any authorized distributors, resellers or authorized partners. RDECOMs ECBC EML requires these kits to detect biological warfare agents using ElectroChemiLuminescent (ECL) technology. These products are unique and are only available from one source, which is Meso Scale Defense.
MSD ECL test kits are specifically designed to be used in conjunction with the MSD PR21800 instrument, which ECBC's laboratory currently owns. The required test kits are customized products which are designed, approved and validated by both the MSD Laboratory and EBML. The MSD test kits have been rigorously tested using standards set by ISO17025 and the Joint Program Executive Office Quality Program (JPEOQP) under which the EBML operates. The required test kits utilize MSD's propriety multiplexed ECL technology and fulfills the sensitivity, specificity, and throughput capacity needed for our clients. There are no other suppliers that provide products that incorporate the technology to allow the processing of samples as rapidly and accurately as the MSD platform. MSD owns a number of patents covering the manufacturing of instruments and test kits. MSD has exclusive, permanent and irrevocable license to the fundamental patent portfolio for the ECL technology.
6. Additional Information:

(i) Not obtaining this requirement for MSD test kits will result in the failure to provide a high-level client with validated laboratory capabilities. This client has built a new testing facility that ECBC has outfitted with analytical equipment and reagents. This classified mission provides an important national security function, and a delay in providing these services will have a detrimental effect on national security.

(ii) If MSD does not receive the award, EBML would be forced to find alternate sources for ECL testing of biological agents. The procurement of a different platform would require that this same level of testing be duplicated, costing approximately $1.5 million dollars and three years to complete. Generating comparable statistical data would take an additional $2 million dollars and no less than three (3) years of testing and data analysis. These figures are an approximation based on the amount of labor hours and materials that went into research for the development of these assays, the validation and demonstration of capability of the assays, and the incorporation of the technology into the client's concept of operations. Additionally, the statistical confidence of the assays is based on the number of samples (unknowns and quality assurance samples) which is of paramount importance to the clients. This would also mean a decrease in confidence of EBML and a decrease in client work for the Government.

7. Actions to Increase Competition:

Notice of Intents to negotiate solely with Meso Scale Diagnostics, LLC. have been posted to FEDBIZOPs in 2012, 2013 and 2014 without response from interested contractors. If the need to change ECL platforms arises, new sources will be evaluated other than Meso Scale Defense in an effort to increase competition in the future. This will be accomplished by performing a market survey in advance of designing new protocols and equipment recommendations, by identifying several equipment choices that could be used for process development, and then competing for best value equipment.

8. Market Research:
MSD is the only source for these test kits and there are no other suppliers. Due to the proprietary nature of the kits, there are no other comparable commercially available or customizable kits on the market.
Market research is being conducted continuously by EBML biologists and scientist at Department of Homeland Security (DHS). Monthly research and development telecons take place to discuss new and upcoming technologies. Currently The MAGPIX platform (Luminex Corp.) is the only comparable platform to the PR21800 in use. However, the assays for this instrument are not as sensitive as the kits we intend to purchase and does not meet the needs set forth by the client. Also, it has been determined just recently the assay kits that were available through DHS are not available at this time.

9. Procurement History:

Previous Contract or Purchase Order Number:

Contract: W91ZLK-15-P-0500
Contractor: Meso Scale Defense

Contract: W91ZLK-14-P-0399
Contractor: Meso Scale Defense

Contract: W91ZLK-14-P-0061
Contractor: Meso Scale Defense

Contract: W91ZLK-13-P-0505
Contractor: Meso Scale Defense

Contract: W91ZLK-13-P-0208
Contractor: Meso Scale Defense

Contract: W91ZLK-12-C-0015
Contractor: Meso Scale Defense

Previously competed? No