A03_SSJ_Abbott_m2000_ja-18-294_Redacted.pdf

Control No: JA-18-294

Sole Source Justification (SSJ) in accordance with FAR subparts 13.106 using Simplified

Acquisitions Procedures (SAP)

1. Contracting Activity: The Contracting Activity responsible for this action is the US Army

Medical Research Acquisition Activity, Fort Detrick MD.

2. Requiring Activity: The Requiring Activity for this action is the Walter Reed Army Institute of Research (WRAIR), Military HIV Research Program (MHRP), and Department of

Laboratory Diagnostics and monitoring (DLDM).

3. Nature of Action:

Commercial Item Non-Commercial Item

New Requirement Follow-on Requirement

Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price* Time & Materials** Cost*

* See FAR 12.207(a)

** See FAR 12.207(b).

For Hybrid Contracts, list percentage of each type of pricing:

* Firm Fixed Price:

**Time & Materials:

* Cost:

Funds: RDT&E Operations and Maintenance, Army (OMA) Other Funds: MEDCOM

Fiscal Year of Funds: FY18

Estimated Total Dollar Value including Options:

4. Contractor Name:

Name of Proposed: Abbott Molecular Inc.

Street Address: 1350 E. Touhy Avenue

City, State, Zip: Des Plaines, IL 60118-3315

Phone: 800-553-7042 Option 1

DUNS: 604784095

CAGE CODE: 44Z73

5. Description of Supplies/Services: The requirement is for Abbott M2000RT System and

Abbott m2000sp Instrument E Series (Abbott Molecular Diagnostics, Inc.) needed to support continued research activity for malaria vaccine clinical trials and diagnostics of malaria patient samples from Department of Defense (DoD) Military Treatment Facilities (MTFs).

6. Authority Cited: 41 U.S.C. 1901 OR 41 U.S.C. 1903

FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name);

OR

FAR 13.501(a)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item.

7. Reason for Authority Cited: The Abbott m2000 sp/rt System combines high throughput fully automated specimen preparation and highly sensitive detection of nucleic acids in one platform. It is the only system currently available that can perform FDA approved tests including HIV-1, HCV, HBV, CT/NG, CMV, HCV Genotype, Zika (EUA), IDH2, and LDTs on a single fully-automated molecular platform. The m2000sp is an open platform that offers flexible protocols for various sample types and volumes, including RNA, DNA, and Total

Nucleic Acid options. Therefore, the Abbott m2000 sp/rt allows for complete flexibility in defining laboratory-based real-time PCR applications. The Abbott m2000 sp/rt System will provide DLDM, MHRP, and WRAIR with the enhanced capability to support the implementation of a College of American Pathologist (CAP) validated malaria molecular diagnostic assay. The Plasmodium pan (genus) 18S RNA qPCR assay developed by Dr. Murphy at the University of Washington (UW), Seattle, WA is executed on this system; FDA 510K clearance is imminent. The procurement of the Abbott m2000 sp/rt System is essential for implementation of a CAP validated malaria molecular diagnostic assay at the WRAIR in support of malaria vaccine clinical trials and clinical diagnostics of malaria patient samples from DoD

MTFs.

The Abbott m2000 sp/rt System has been validated for the malaria molecular diagnostic assay by

Dr. Murphy, UW, and is currently pending US FDA clearance as a 510K Laboratory Developed

Test (LDT). Dr. Murphy has agreed to tech transfer his assay to the WRAIR in support of

MHRP/WRAIR’s effort to implement a CAP validated malaria molecular diagnostic assay to support malaria diagnostics for malaria clinical vaccine trials and MTFs. Procurement of a competitor instrumentation which does not have an intended use claim for a malaria diagnostics would significantly delay implantation of a CAP validated assay for the Plasmodium species, incur significant cost to the government for development and re-validation of a malaria molecular assay which would not be US FDA cleared for intended use for Plasmodium molecular detection. Procurement of the Abbott m2000 sp/rt system will allow the MHRP/

DLDM/ WRAIR to implement a high through-put assay under US FDA cleared, prescribed conditions employing proven methods and materials, thereby providing significant labor and cost savings.

8. Efforts to Obtain Competition:

a. Effective competition. No effective competition is anticipated. Current Market

Research has identified that no alternatives exists for this equipment. A Notice of

Intent to Sole Source will be posted to FBO for 15 days prior to contract award.

Any interested parties technical capabilities will be evaluated.

b. Subcontracting competition. No subcontracting is expected.

9. Actions to remove or overcome barriers to competition: WRAIR will continue to undertake market research and survey the market for another analyzer that can meet the

Government’s requirements.

10. Market Research: WRAIR conducted market research through the System for Award

Management (SAM) and on multiple search engines using multiple key terms and criteria specific to this effort. We found no other businesses that were able to produce the product required by MHRP. Internet searches, including the consultation of GSA Advantage and

ECAT, were conducted to determine if any other vendors were capable of meeting the requirement. Based on the results of the research Abbott Molecular Inc. is the only vendor capable of meeting MHRP’s requirement.

11. Interested Sources: To date, no other sources have written to express an interest in this requirement.

12. Procurement History and other facts:

a. Previous Contract or Purchase Order Number: The previous purchase of this equipment cannot be identified on a contract.

b. Previously Competed? NA.

c. Previous authority for less than Full & Open Competition: NA.

13. Technical/Requirements Certification: I certify that the support data under my cognizance which are included in this SSJ are accurate and complete to the best of my knowledge and belief.

14. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. Based upon the facts described herein, I hereby determine that the anticipated price/cost to the Government will be fair and reasonable and a determination of price reasonableness will be documented and placed in the contract file.