N3239824Q9982 JAA_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 DoD Bone Marrow Program to meet Navy Expeditionary Medical

Research requirements.

2. Nature and/or description of the action.

The proposed action is the continuation of research to develop an NGS-based assay using hybrid capture technology to assess response to various immunosuppression protocols (drugs) in the surveillance of HSCT patients. The second phase of the project (September 2024 to May 2025) will be divided into three stages. Within this phase, CareDx Lab Solutions, Inc. will expand the probe design to add bulsulfan- specific gene targets, optimize the probe design for a better specificity, perform verification of the assay and initiate development of the interpretation software. Software development will not be completed within this phase. The Government intends on awarding a Firm Fixed Price contract. The proposed source is CareDX Lab Solutions, Inc as a continuation of services from XXXXXXXXXXX.

3. Description of Supplies or Services:

The Naval Medical Research Command (NMRC) requires research to develop genetic screen for deleterious pharmacogenetic variants involved in immunosuppression modulation in post- HSCT management. The Second stage of the project will include three stages:

Stage I: Optimization

• Design and kit format optimization.

• Re-testing with a revised probe panel.

Stage II: Verification and Validation of the Beta kit

• Internal verification and validation.

• Testing BAMC patient samples for PGx and HLA allele frequency - run analysis and result interpretation; (proposed 2000 samples). Final number and timelines are subject to change due to BAMC patient samples availability.

Stage III: Software development - initiation phase

• Initiation of the interpretation software development.

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:

10 U.S.C. 2304(c)(1), Only one responsible source.

10 U.S.C. 2304(c)(3), Industrial mobilization; engineering, developmental, or research capability; or expert services.

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

CareDX Lab Solutions, Inc. is currently the only company that utilizes hybrid capture technology for HLA genotyping. CareDX Lab Solutions, Inc. has the manufacturing process know how for the potential kit. Potential for successful commercialization of a similar kit using the same NGS-based HLA typing methodology used in pre-transplantation utilizing hybrid capture technology.

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

Market research was previously performed, the results of which are in paragraph 8. This requirement will be posted to NECO and/or SAM.gov in accordance with FAR 5.202.

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 CareDX Lab Solutions, Inc.

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 by technical experts in the April 2023 timeframe. This research consisted of a market survey through search engines of open market contractors and Federal

Supply Schedule contractors. Search engines utilized include Google and GSA Advantage using the following search words: Pharmacogenetics NGS-Based kit separate and in combination.

CareDX Lab Solutions, Inc. holds the proprietary knowhow for the NGS-based and DNA

Purification required for this kit. The results of the market research are attached.

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

This is a novel technology that only now has scientific evidence to try to develop the pharmacogenetic genotype kit.

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, NMRC 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 Center, Silver Spring, MD, regarding the contents of the sole source justification is, Shamai M. Carter, who may be reached at (301)

319-7182.

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

GROGL.MAX.10

52856031

Digitally signed by

GROGL.MAX.1052856031

Date: 2024.04.17 11:32:09

-04'00'

Dr. Max Grogl Phone Date

Head DoD Bone Marrow Program

Naval Medical Research Center

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.

(301) 319-7182 5/7/2024

Contracting Officer Phone Date