JA.docx

JUSTIFICATION AND APPROVAL OTHER THAN FULL AND OPEN COMPETITION

Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Research Center (NMRC), Silver Spring, MD, on behalf of the Navy to meet the Naval Medical Research and Development mission.

Nature and/or description of the action.

The need is for a NovaSeq, a state-of-the-art sequencing instrument manufactured by Illumina. The Government intends on awarding a Firm Fixed Price contract. The proposed source is Illumina, Inc., 5200 Illumina Way, San Diego, CA 92122.

Description of Supplies or Services:

The Genomics & Bioinformatics Department of the Biological Defense Research Directorate, Naval Medical Research Center maintains a state-of-the-art genomics and bioinformatics research program. We are currently engaged in sequencing of COVID-19 samples for studies aimed at contributing to understanding and halting the COVID-19 pandemic. As part of this on- going effort, Illumina instruments, the DoD-accepted standard in High-throughput Sequencing (HTS) workflows are being utilized.The requirement is for a NGS system with an output of ~5-6 Tb and ~20 B reads that can be used for the sequencing of short-reads SARS-CoV-2 (and other RNA viruses) amplicon libraries.

The required genetic sequencer must satisfy the following minimum requirements:

a) Shall provide a touch screen.

b) Shall provide a calibrated screen indicating flow cell status and immediate analysis interpretation

c) Shall provide a Linux based computer engine

d) Shall provide Windows 10 operating systems

e) Shall provide image analysis software

f) Shall provide base calling software, which is the process of assigning bases to various compounds.

g) Shall provide user interface software

h) Shall provide anti-virus software

i) Shall run over 5000 samples sequenced per run.

j) Shall have a 0.00% error rate.

k) Shall provide interoperability/connectivity with the co-existing MiSeq sequencer.

l) Shall include communication capabilities with the co-existing MiSeq sequencer.

m) Shall include snap-in cartridges containing ready-to-use reagents

n) Shall include waste containers

o) Shall include comprehensive sequencing and informatics ecosystem that include Laboratory Management System (LMS)

q) Shall operate at 110V/60Hz, 220V/50Hz: 200-240V/47-63Hz

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.

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

Illumina, Inc. is the OEM of the NGS (Next-generation sequencing) laboratory system and thus is the ideal source of the products. In addition, Illumina, Inc. is the only manufacturer that can provide the required reagents. This standalone NGS system the DoD-accepted standard for NGS. The NovaSeq 6000 has a max output of 3000 Gbs, NovaSeq 6000 has an error rate of 0.00%.

Description of efforts made to ensure that offers are solicited from as many potential sources as practicable. There are no other manufacturers of the required products. Market research was performed, the results of which are in paragraph 8. This requirement will be posted to SAM.gov in accordance with FAR 5.202.

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 covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made.

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 July 2021 timeframe and by the Contract Specialist on 3 August 2021. Illumina, Inc. is a large business with at least one small business distributor. Government Scientific Source is a distributor of Illumina Inc.

Similar products are found in the marketplace, however these products did not meet the NMRC essential requirements. MinION can only virus sequence 128 per run, BioRad can only virus sequence 204.8 per run, and PacBio can only virus sequence 64 per run. Additionally, MinION, BioRad, and PacBio have error rates of 13%, 1.8%, and 12%, respectively.

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

Illumina is the manufacturer of the NovaSeq 6000.

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.

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 services covered by this document. If another potential source emerges, NMRC will assess whether competition for future requirements is feasible.