Sources Sought Notice.pdf

Sources Sought Notice: Market Research for Clinical Research Support Reference Number: SS-NAMRU-258C2 Issuing Office: U.S. Naval Medical Research Unit Europe, Africa, Central (NAMRU

EURAFCENT)

Project Title: Clinical Research Support for Tropical Fever Diagnostic Evaluation

1.0 Synopsis

This is a SOURCES SOUGHT NOTICE for market research purposes only. This is not a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of qualified business sources to provide the services described below.

The Naval Medical Research Unit Europe, Africa, Central (NAMRU EURAFCENT) is seeking to identify interested and capable parties to provide non-personal services for a clinical research study titled, "Clinical evaluation of the Xpert® tropical fever test on the Genexpert® Edge X system using venous and capillary whole blood specimens" (Protocol 258C2). The Government will use the information received to determine its acquisition strategy.

2.0 Background

NAMRU EURAFCENT is planning a clinical study to evaluate the performance of the Xpert® Tropical Fever test, an automated molecular diagnostic assay designed to identify nucleic acids from multiple fever-causing pathogens, including Plasmodium species, Dengue virus, Zika virus, Chikungunya virus, and Leptospira species. The primary objective is to evaluate the test's clinical performance when used with venous and capillary whole blood by minimally trained users in an environment representative of a clinical point-of-care setting.

3.0 Required Services & Scope

The contractor shall provide all personnel, equipment, supplies, facilities, and other non-personal services necessary to execute the clinical study at the Komfo Anokye Teaching Hospital (KATH) in Ghana. Key tasks include, but are not limited to:

Project Management: Provide qualified personnel for all roles, including Principal Investigator(s), clinical staff, phlebotomists, laboratory technicians, and administrative support.

Regulatory Compliance: Obtain and maintain all necessary approvals from the local Institutional Review Board (IRB), ensure adherence to Good Clinical Practice (GCP), and manage all study documentation.

Patient Enrollment: Screen, consent, and enroll approximately 300 patients who present with clinical suspicion of tropical fever, following the IRB-approved protocol.

Sample Collection & Processing: Collect venous and capillary blood samples from enrolled patients.

Diagnostic Testing: Perform on-site testing using the Government-furnished GeneXpert Edge X system.

Comparator Analysis: Perform comparator testing using the Biofire Global Fever Panel and conduct discrepant analysis via sequencing.

Data Management: Ensure accurate and timely data entry, quality assurance, and secure storage of all study data.

Reporting: Provide regular monthly status reports, teleconference updates, and other deliverables as required to NAMRU EURAFCENT.

4.0 Place & Period of Performance

Place of Performance: The work will be performed at the Komfo Anokye Teaching Hospital (KATH), Ghana.

Period of Performance: The anticipated period of performance is one (1) 12-month base year, with one (1) 6-month option period.

5.0 Government-Furnished Items

The Government, in conjunction with its partner Cepheid, will provide the GeneXpert machine, all associated test kits and cartridges, and specific supplies for sample collection and shipping.

6.0 Requested Information & Capabilities

Interested parties are requested to submit a capability statement (not to exceed 10 pages) that demonstrates the ability to perform the services described in this notice. The statement should address the following areas:

Company Profile:

Company Name, Address, and website.

Point of Contact (Name, Title, Email, Phone).

UEI Number and CAGE Code.

Business size and any applicable socio-economic classifications (e.g., Small Business, etc.).

Past Performance:

Provide brief descriptions of up to three (3) relevant projects completed within the last five (5) years. For each project, describe its scope, your company's role, and how it relates to the requirements of this notice. Emphasize experience with:

Infectious disease clinical trials.

In vitro diagnostic device evaluations.

Conducting research in Ghana or the West African region.

Technical & Management Capability:

Personnel: Describe your ability to recruit, hire, and manage qualified local personnel, including roles such as Principal Investigator, physicians, phlebotomists, laboratory scientists, and study coordinators.

Facilities: Describe your access to, or ability to secure, suitable laboratory space (BSL-2 or equivalent) at or near the Komfo Anokye Teaching Hospital.

Regulatory Expertise: Detail your experience with securing and maintaining approvals from Ghanaian IRBs and your familiarity with Good Clinical Practice (GCP) guidelines.

Logistics: Explain your capability to manage the logistics of a clinical study in Ghana, including security for personnel and government property.

7.0 Submission Instructions

Due Date: Capability statements must be submitted via email no later than March 12, 2026 at 2:00 PM (1400 hours), Central European Time (CET).

Submit To: Please email your response to the Points of Contact:

CDR Christina Jamros: christina.m.jamros.mil@health.mil

Dr. Naiki Attram: attramn@state.gov

Dr. Shirley Nimo Paintsil: nimopaintsilsc@state.gov

Terry Herbert: terry.l.herbert3.civ@us.navy.mil

Subject Line: Please use the following subject line for your email: "Response to Sources Sought Notice: SS-NAMRU-258C2 - [Your Company Name]".

8.0 Disclaimer

This sources sought notice is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the U.S. Government. The Government does not intend to award a contract on the basis of this notice or to otherwise pay for the information solicited. No solicitation document exists at this time. All information received in response to this notice that is marked as proprietary will be handled accordingly.