JA_HT942525DE001_Redacted.pdf

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

1 NOV 2024

Control Number: FY25-0234

Justification and Approval (J&A) Modified for Federal Acquisition Regulation (FAR) 13.501

1. Identification of the Agency and Contracting Activity: Defense Health Agency (DHA) United States Army Medical Research Acquisition Activity (USAMRAA), Contracts Branch 3.

2. Nature and/or Description of Action being Approved: The United States Army Medical Research Institute of Infectious Diseases (USAMRIID) requires a brand name procurement of Kilobaser equipment. This requirement will be a new Firm Fixed Price, Indefinite Delivery Indefinite Quantity (IDIQ) contract with a 5-year ordering period. All United States Army Medical Research and Development Command Research (USAMRDC) Labs will be able to purchase from this ordering vehicle.

3. Description of Supplies/Services: This new supply requirement is for the delivery of

Kilobaser equipment, such as ONE-XT Benchtop Synthesizer, Nitrogen Generator, associated reagents, software, touch screen, gas appliances and online training for setup, and basic and extended features cartridges, microfluidic chips, and other consumables are required. This is a unique requirement that enhances the capability to produce primers and probes for assays critical for the detection of infectious diseases.

4. Statutory Authority Permitting the Sole Source Acquisition: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

Controlled by: Defense Health Agency (DHA) Controlled by: USAMRAA CUI Category(ies): Source Selection Limited Dissemination Control: FEDCON

CUI Control Number: FY25-0234

Source Selection Information - See FAR 2.101 and 3.104-4

2 NOV 2024

Rationale Justifying Use of Authority Cited: A brand name exception to fair opportunity is required for this procurement because the Kilobaser equipment and consumables are essential for timely performance, which does not compare to the performance to other commercially available Deoxyribonucleic acid (DNA) and Ribonucleic acid (RNA) synthesizers. The Kilobaser directly supports the mission to establish a rapid synthetic biology response capability for real-time biological threats. This capability will be deployed within the USAMRIID Special Pathogens Laboratory to provide rapid response testing of infectious disease threats to the Nation and the Warfighter. Consequently, failing to procure the Kilobaser system would significantly impair USAMRIID's ability to deliver timely diagnostic capabilities for critical biothreats. USAMRIID already has multiple pieces of the Kilobaser equipment. No other brand can provide a product with the unique characteristics and capabilities of the Kilobaser Personal ONE-XT Benchtop Synthesizer. Procuring this requirement will ensure the continuity of the mission and their research.

The Kilobaser ONE-XT Benchtop Synthesizer uniquely enables the rapid production and modification of DNA and RNA oligonucleotides, including TaqMan probes. This capability allows for the on-demand generation of all custom reagents needed for real-time Polymerase Chain Reaction (PCR) assays. The Kilobaser Nitrogen Generator is critical for the portable operation of the Kilobaser DNA/RNA synthesizer, enabling its deployment in diverse settings.

The Kilobaser system's unmatched ability to synthesize and modify oligonucleotides in under two hours facilitates the rapid development of real-time PCR assays within hours of identifying a new pathogen sequence.

It is for these reasons that the Kilobaser DNA/RNA Synthesizer, Nitrogen Generator, and associated reagents are uniquely suited to fulfill USAMRIID’s mission, making Kilobaser the necessary brand name provider of this specialized equipment. If another commercially available system was procured instead, a more labor-intensive sequence analysis and assay modifications to ensure adequate assay inclusivity. This process will slow down the production of the requirement and will impact USAMRIID’s mission and research. Also, other products dispense reagents via open column system increasing risks of contamination and chemical exposure to operators. Additionally, other products require argon gas, which is typically not as readily available as nitrogen gas and dispenses reagents via open column system which increases the risk of contamination and chemical exposure to operators. Furthermore, some products that are a closed system require connection to the internet. These options do not meet the government’s requirement.

Efforts to Obtain Competition: In accordance with FAR 5.2 – Synopses of Proposed Contract Actions, a Notice of Intent (NOI) to award a sole source contract was posted on System for Award Management (SAM.gov) on 23 May 2025 for 15 days with a response due date of 09 June 2025. The Contracting Office received emails from Cloud Gov Inc. and Joy of Life Company, stating they are authorized resellers of the Kilobaser equipment Therefore, the Government intends to compete this requirement as Brand Name only. All capability statements received in response to the NOI to Sole Source, by the due date specified, were considered by the Government solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract.

3 NOV 2024

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition:

USAMRIID and USAMRAA will periodically conduct future market research and analysis to determine if other potential sources emerge that can provide the required ability to establish a rapid synthetic biology response capability in response to real-time threats by utilizing the Kilobaser equipment and consumables.

8. Market Research: Market research conducted in between March 2025 and April 2025 in accordance with FAR Part 10 was multifaceted and was undertaken to ascertain 1) if the requirement meets the FAR definition of a Commercial Supply; 2) if two or more small businesses exist that can meet the Government’s requirement; and, 3) if there is more than one source capable of meeting the governments requirement.

Market research examined if the requirement met the FAR definition of a commercial product, as specified in FAR Part 2, which is a product, other than real property, that is of a type customarily used by the general public or by nongovernmental entities for purposes other than governmental purposes and (i) has been sold, leased, or licensed to the general public; or (ii) has been offered for sale, lease or license to the general public. Market research determined that the requirement does meet this definition and is commercially available; thus, commercial terms and conditions will apply.

Market research conducted in accordance with FAR Part 10 does not support that a minimum of two or more capable small businesses could potentially satisfy this requirement. Only one small business was identified. Given the information above, this requirement is not appropriate for a small business set-aside.

Market research identified the following vendors capable of providing DNA/RNA synthesizers:

Mabel’s GmbH; Biolytic Lab Performance, Inc.; Sierra BioSystems; and K&A Labs. Mabel’s GmbH DNA/RNA Synthesizer (Model: Kilobaser one-XT) can produce DNA and RNA oligonucleotides; can modify these oligonucleotides for use as a TaqMan probe, thus generating all the custom reagents needed for a real-time PCR assay; and, has a defined process for transitioning real-time PCR assays to a Laboratory Developed Test (LDT) for formal clinical patient testing. Biolytic Lab Performance’s product (Model: Dr. Oligo 48) dispenses reagents via open column system increasing risks of contamination and chemical exposure to operators and, therefore, cannot meet the government’s requirement. Sierra BioSystems product (Model: Shasta 96- 192 Oligo Synthesizer) requires argon gas, which is typically not as readily available as nitrogen gas and dispenses reagents via open column system which increases the risk of contamination and chemical exposure to operators and, therefore, cannot meet the government’s requirement. Lastly, although K&A Labs product (Model: H-8 or H-32s) is a closed system it does require connection to the internet which does not meet the government’s requirement.

Market research identified the following vendors capable of providing nitrogen generators:

Mabel’s GmbH; Terra Universal; South-Tek Systems LLC and Nano-purification Solutions.

USAMRIID currently has four (4) Kilobaser ONE-XT Benchtop Synthesizers in operation.

Nitrogen is a requirement for these systems to operate, and USAMRIID requires a portable nitrogen generator to run the Kilobaser DNA/RNA synthesizer in remote and austere locations.

Terra Universal’s product (Model: 2700-99) is a large unit with movability based on being a wheeled unit and is not carriable with a weight of 65 lbs. South-Tek LLC product (Model:

4 NOV 2024

N2GEN-4) is portable but includes a large external gas tank with a separate generator unit. While their other product (Model: N2GEN 4HC) is in a portable case with a small integrated tank the unit weighs 150 lbs. Nano-purification Solutions (Model: GEN2MINI-060) is the smallest model that still weighs 119 lbs. Furthermore, the compatibility of all the products with our existing equipment (Kilobaser ONE-XT Benchtop Synthesizer) is unknown.

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement? No

(2) If 9.a.(1) is No, was the action just prior to this one competed? Yes – brand name.

(3) If 9.a.(2) is Yes, what has changed where this action cannot be competed? N/A.

This action is also being competed as brand-name.

b. Additional Information: Kilobaser products have been previously purchased under contract number HT942523P0085 and was competed as brand name only for three kilobasers in support of USAMRIID. Also, one kilobaser was purchased under HT942524P0117 in support of USAMRIID and was not competed as a brand name.

These prior two contracts were awarded as individual contract and this new requirement will be awarded as an IDIQ and open to all USAMRDC laboratories.

10. Interested Sources: The synopsis required by FAR 5.201 will be posted on the SAM.gov website as this requirement meets the threshold stipulated in FAR 5.101(a)(1). Any written inquiries, bids or proposals received shall be considered.