1.04 Sole Source Justification v3.pdf

JUSTIFICATION FOR SOLE SOURCE (Simplified Acquisitions - MPT to <$250K)

Document number: ________________________

The supplies or services described herein are being solicited on a sole source basis and competition is precluded for reasons indicated below. There are no substitutes available for the supplies or services.

Check One:

Service:

Contractor:

Contractor Address:

Contractor POC:

Phone #:

Email:

Cage Code/DUNS:

Supply:

Restricted to the following source. If a sole source manufacturer distributes via dealers, ALSO provide dealer information.)

Original Manufacturer Name:

Manufacturer:

Manufacturer POC:

Manufacturer Phone #:

Manufacturer Address:

Dealer/Rep:

Dealer/Rep Address Phone No.

Email:

Description of the supplies or services required, the estimated price/cost, and required delivery date.

The mission of the U.S. Naval Medical Research Unit INDO PACIFIC (NAMRU INDO PACIFIC) is to monitor and characterize emerging and re-emerging infectious diseases of military and public health importance, and to develop mitigation strategies against these threats in partnership with U.S., host nation, and international agencies in the Indo-Pacific region. To accomplish this mission, NAMRU INDO PACIFIC contracts with the private sector for R&D services. In this requirement, contractor services are needed to examine infectious disease threats in various countries around the Indo-Pacific Command (INDOPACOM) Area of Responsibility (AOR). The primary objective is to provide support to existing health facilities and research based infectious disease surveillance networks that survey and identify biothreat, endemic tropical and respiratory threats, and antimicrobial resistant (AMR)/multidrug resistant organisms (MRDO) illness etiologies among patients and other volunteer subjects, as well as zoonotic and environmental sources.

The specific objectives are to support existing NAMRU INDO PACIFIC biosurveillance projects across INDOPACOM AOR to:

1. implement standardized laboratory procedures to detect biothreat agents, arboviruses, and antibiotic resistant organisms from contrived, environmental, zoonotic or patient samples,

2. develop detailed consensus genomes for a select subset of regional pathogens of concern, and

3. provide the capability to identify novel emerging and re-emerging infectious diseases in the region.

The estimated cost is $219,470.02 and the required delivery date is 15 Sep 2025 - 14 Sep 2026.

In conclusion, the requested supplies or services represent the minimum requirements of the government.

Source Selection Information See FAR 2.101 and 3.104

8R6V6

Describe in detail why only this source can furnish the requirements to the exclusion of other sources.

(what specific characteristics of the supplies or services limit the availability to a sole source (e.g., unique

The supplies or services must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system.

The services sought are for research and development concerning both bacterial and viral infections. There are many commercial vendors with capabilities to perform Next Generation Sequencing (NGS) for bacterial infections. However, for viral infections, the low levels of viruses often require target enrichment, which can be done by panels containing DNA probes (e.g., Illumina Viral Surveillance Panel, Twist Pan-Viral Panel). Pathoseq Bio, LLC (previously named PraesensBio) has developed a Pan-Viral Panel to test unknown specimens for around one-thousand genomic sequences for viruses endemic to Indo Pacific. Pathoseq Bio's Pan-Viral Panel is a target enrichment panel that can be used with the Oxford Nanopore Technologies (ONT) MinION NGS device that NAMRU Indo Pacific partners use across Indo Pacific. The ONT is considered the only portable real-time device for DNA and RNA sequencing. The ONT MinION NGS device is also uniquely compatible with the NAMRU INDO PACIFIC biosurveillance schemes due to its low maintenance, ease of use, and small physical footprint.

Consequently, Praesensbio’s panel is the only system that is able to provide the pan-viral identification capability needed to provide expanded capabilities for genetic screening and diagnostics of pathogens in operational settings using the handheld and highly portable MinION sequencer. No other sources can provide a multi-viral Twist Pan-Viral Panel for the MinION NGS device. For this reason, PraesensBio LLC is the sole source vendor.

Failure to procure these research and development services would result in the inability for the United States Navy to detect and research novel pathogens. This would limit the ability for preemptive research to develop identification tools, antiviral/antibiotic agents, and accurate diagnosing procedures. The lack of these tools would put the Navy in a more vulnerable posture in response to future outbreaks and future management of disease throughout the organization.

Document number:

I CERTIFY THAT THE INFORMATION PROVIDED ABOVE IS COMPLETE AND ACCURATE TO THE BEST OF

MY KNOWLEDGE. I UNDERSTAND THAT THE PROCESSING OF THIS SOLE SOURCE JUSTIFICATION

PRECLUDES THE USE OF FULL AND OPEN COMPETITION.

Signature Date

Activity Title

I HEREBY DETERMINE THAT THE CIRCUMSTANCES OF THE CONTRACT ACTION DEEM ONLY ONE

SOURCE REASONABLY AVAILABLE IN ACCORDANCE WITH FAR 13.106-1(b)(1)(i).

Contracting Officer Signature Date

NAVSUP Fleet Logistics Center, Norfolk Contracting Department