Part_13.5_Single_Source_Commercial_Over_SAT.pdf

Justification and Approval Justification Under Simplified Procedures for Certain Commercial Items in Accordance with FAR 13.5

This acquisition is conducted in accordance with Federal Acquisition Regulation (FAR) 13.106-1(b)(1), Soliciting from a single source, under the authority of Simplified Acquisition Procedures (41 U.S.C. 1901).

1. Identification of the agency and the contracting activity.

a. Federal Agency and Contracting Activity Health and Human Services (HHS), National Institutes of Health (NIH)

b. Sponsoring Organization

National Institute of Allergy and Infectious Diseases (NIAID), DIR/Center for Human Immunology, Autoimmunity, and Inflammation (CHI)

c. Project Officer

Dr Richard Apps 10 Center Dr BG 10 RM 7n112a Bethesda, MD 20814 Richard.Apps@NIH.gov (240)-669-5475

2. Nature and/or description of the action being approved.

a. Brief Summary and Program Background

The Center for Human Immunology, Autoimmunity, and Inflammation (CHI) is studying the biology of the immune system on a global scale, including at the proteomic level. The CHI aims to study and characterize both the normal and pathogenic immunome. Characterizing the serum proteome is fundamental to understanding these systems. Using computational biological approaches coupled with more traditional biological experimentation, the CHI strives to build models of how the mammalian immune system responds to pathogens, disease progression, treatments, and vaccines.

These models allow us to make informed predictions as to how the body will respond to immunological events (like infection, treatment, disease progression, and outcomes).

CHI requires SOMAscan Assay 7,000 plex proteomic profiling assay using human serum samples collected from patients enrolled in the Adaptive Treatment Trial (ACTT; ClinicalTrials.gov Identifier: NCT04280705) to measure effects of clinical treatments and outcomes at different timepoints in disease progression. The SOMAscan Assay allows fast serum proteome profiling of more than 7,000 protein markers. The assay is performed on a proprietary platform at SomaLogic’s testing facility, and the data generated/results from the platform is delivered electronically. The proteomic information gained from this acquisition will be coupled to information from orthogonal experimental techniques to uncover a systems immunology-based model of treatment and outcomes of treatment for those with human disease.

b. Project Title

Serum Proteomic Signatures of Human Disease Intervention Using Remdesivir with and without Interferon Alpha

c. Nature of the Action

Requirement type.

Support services (non-research & development) Supplies/equipment Information technology (IT) Other (specify): ______________________

Type of action. Check the appropriate box:

New requirement Follow-on Short-term Bridge Other (specify): ______________________

Proposed contract/order type. Check all that apply:

Firm-fixed-price Other fixed-price Type: (specify e.g., fixed-price award-fee, fixed-price incentive-fee) Time and materials Indefinite delivery Type: (specify whether indefinite quantity, definite quantity, or requirements) Other (specify): ______________________

Acquisition Identification Number

AMBIS # 2083459

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Description of the Required Supplies/Services

The CHI is studying the systems biology of the immune response to human disease therapeutic interventions on many levels, including on the proteomic level. The requirement is to obtain serum proteomic profiling data on 7,000 analytes using the SomaScan 7K HTS Assay. The SOMAscan Assay is an aptamer based proteomic affinity assay that quickly (<48 hours) quantifies the relative expression of 7,000 protein markers in 52 uL of human serum. The SOMAscan Assay Service will be utilized to examine the proteomic state of 1,000 patients infected with human disease undergoing treatment with Remdesivir with and without interferon alpha. See statement of work for additional details.

b. Total estimated dollar value and performance/delivery period

Estimated dollar value inclusive of options: $600,000.00 Performance period: One (1) year from date of award

4. An identification of the statutory authority permitting other than full and open competition.

a. Acquisition authority: In accordance with FAR 13.106-1(b)(1) and 13.501(a)(1)(ii), following the guidance of FAR 6.302-1 Only one responsible source, and as authorized by:

41 U.S.C. 1901 Simplified Acquisition Procedures

41 U.S.C. 1903 Special Emergency Procurement Authority

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

a. Exclusive and Required Nature of the Product(s) and/or Service(s)

The SomaScan is a proprietary test provided solely by SomaLogic. The SomaScan assay has the following unique features: Assay qualification studies show that the SomaScan Assay performs with median sensitivity of 100 fM (limit of detection) and median coefficient of variation (CV) of approximately 5% across all analytes measured repeatedly in replicate runs of biospecimens. In addition, the overall detection range of the platform spans 8 logs of dynamic range in serum. The Assay provides high throughput (96 samples per plate), highly multiplexed (>7,000 analytes), rapid (<48-hour turnaround) results. No other kit or technology can measure as many analytes in serum as quickly, precisely, or with equally lower serum volume requirements.

Additionally, the SomaScan Assay HTS Kits have been used in ongoing longitudinal studies at the CHI and as a fee-for-service for the intramural NIH community. The assay needs to have the same performance as those used in previous studies to promote continuity and limit variation and addition of new variables. This will ensure on-going research and experiments are not compromised with changing variables. Maintaining existing protocols is paramount to the success of on-going projects.

b. Only one Source Available

Name and address of the proposed contractor(s) if applicable

SomaLogic, Inc.

2945 Wilderness Place Boulder, CO 80301 Phone: (303) 625-9000 Fax: (303) 545-2525

Proposed contractor(s) unique qualifications

The SomaLogic SomaScan assay and SomaSignal tests are proprietary assays. Smaller batches of assays are performed by other vendors but only SomaLogic is available to handle large scale assay testing using their proprietary methods. Since they are both manufactured and performed only by SomaLogic, they are the only source currently available to provide these services.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

A synopsis of the intent to sole source was published on SAM on 08/10/2021.

7. Determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

Some hospitals offer the testing services and pricing for similar tests from Harvard Medical School were available for comparison, even though this vendor would not be able to process testing on the scale required for clinical studies (these services are provided for single patients instead). The anticipated cost to the government is $708,330.00 based on the average of the available pricing information for identical or similar equipment. See Market Research memo in file for additional details.

8. A description of the market research conducted (see part 10) and the results or a statement of the reason market research was not conducted.

The results of market research have determined that the Government's needs can be met by items of a type customarily available in the commercial marketplace. Required sources, Federal Supply Schedules, and internal sources for the equipment were reviewed. No mandatory or preferred sources were identified. Market research showed that there are few sources for proteomics assay testing in general and no other sources of the required aptamer-based proteomics assay testing. There is only one source for the specialized equipment, SomaLogic, Inc., which is a large business. See Market Research memo in file for additional details.

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

N/A

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed an interest, in writing, in the proposed acquisition.

11. A statement of the 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.

It is the policy of NIAID to promote the use of competitive procedures whenever and wherever possible. In an effort to remove or overcome barriers to competition in the future, the market will be scanned frequently for new companies and products that could satisfy the Government’s requirement.

Vendor, trade magazines, and scientific publications are scanned for new, open scientific changes that can satisfy various on-going protocols. The agency will continually re-evaluate proteomic assays options, and will continue to research the various manufactures and products that could be in the Government’s best interest.

Certifications1

Program office certification. The program officials cited shall complete the information required below and sign the certification in the blocks provided.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Project Officer Richard Apps, CHI, Staff Scientist

Project Officer’s Immediate Supervisor

John Tsang, CHI, Co- Director

Contracting Officer certification. The CO shall complete the information required below and sign the certification in the block provided.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

Christine Illanes, Contracting Officer, AMOB

1 In accordance with FAR 13.501(a)(2), updated 7/1/2021