Clinical Research Support for Tropical Fever Diagnostic Evaluation

Pre-Solicitation Notice: Intent to Award a Sole Source Contract Classification Code: R - Professional, Administrative, and Management Support Services NAICS Code: 541715 (Research and Development in the Physical, Engineering, and Life Sciences)

Subject: Notice of Intent to Award a Sole Source Contract for Clinical Evaluation Services in Support of Protocol 258C2 1. Introduction The Naval Supply Systems Command (NAVSUP) Fleet Logistics Center (FLCI) provides this notice of its intent to award a firm-fixed-price, sole-source contract to the Komfo Anokye Teaching Hospital (KATH) located in Kumasi, Ghana.

This action is pursued in accordance with Federal Acquisition Regulation (FAR) 12.102(a), which allows for restricting competition for acquisitions at or below the simplified acquisition threshold. 2. Description of Services The requirement is for clinical evaluation services as defined in Protocol 258C2 and the associated Performance Work Statement (PWS) for the Naval Medical Research Unit Europe, Africa, Central (NAMRU EURAFCENT).

The work involves the clinical evaluation of the Xpert® tropical fever test on the Genexpert® Edge X system. This will be performed using venous and capillary whole blood specimens from human subjects in Kumasi, Ghana. The estimated period of performance is from April 2026 to October 2027, with an estimated value of $199,787.50.

3. Justification for Sole Source Market research conducted by NAMRU EURAFCENT confirmed that KATH is the only source capable of providing the required services to meet the Government's minimum requirements for the following reasons:

Unique Access to Patient Populations: KATH has established infrastructure and a collaborative history with NAMRU EURAFCENT, providing unique access to the specific patient populations required for this tropical disease research.

Existing Regulatory Approvals: KATH already holds the necessary Institutional Review Board (IRB) and ethical approvals from Ghanaian authorities, which prevents unacceptable delays associated with securing these for a new contractor.

Specialized Facilities and Personnel: KATH possesses the required laboratory facilities, biosafety infrastructure, and trained personnel, including critical experience with the mandatory Cepheid GeneXpert® diagnostic equipment specified in the PWS.

Compliance and Established Trust: As an established partner, KATH is uniquely positioned to perform the required testing in compliance with both U.S. and Ghanaian research ethics standards. 4. Submission of Information This notice of intent is not a request for competitive proposals. However, any responsible source that believes it is capable of meeting the requirement may submit a capability statement.

All capability statements received no later than April 2, 2026, 2:00 PM Central European Time (CET) will be considered by the Government. Electronic responses are permitted and should be sent to the contracting point of contact listed below. The capability statement must provide clear and convincing evidence that the interested party can meet the Government's requirements as stated in this notice.

Disclaimer: A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The Government's decision to solicit from and negotiate with only one source is a discretionary decision. 5. Point of Contact Terry Herbert Contracting Specialist, NAVSUP FLCI terry.l.herbert3.civ@us.navy.mil