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This Pre-Solicitation opportunity from Department Of Defense was posted on August 13, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Procurement of commercial-off-the-shelf (COTS) proprietary BioFire diagnostic assay kits and refurbished systems

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N6817126QN076Federal

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The Naval Supply Systems Command Fleet Logistics Center Sigonella intends to award a firm-fixed-price, sole-source purchase order to Bio Fire Defense, LLC for the procurement of proprietary BioFire diagnostic assay kits and four refurbished FilmArray 2.0 systems. This acquisition supports the Naval Medical Research Unit Europe, Africa, Central in its infectious disease surveillance and research operations across Europe, Africa, and the Middle East. The required materials include various specialized panels for global fever, blood culture identification, gastrointestinal, and respiratory diagnostics, all of which must be delivered to NAS II Sigonella, Italy, within 15 calendar days of the order. The sole-source justification is based on the proprietary nature of the consumables and a Foreign Ownership, Control, or Influence mitigation agreement, which mandates that U.S. Federal Government entities procure these specific biological defense assets exclusively through Bio Fire Defense, LLC. While this is a notice of intent for a sole-source award, interested parties may submit capability statements by August 31, 2026. To be considered, respondents must provide evidence of FOCI agreement compliance, the ability to provide exact part numbers without substitutions, cold-chain logistical capabilities for delivery to Italy, and confirmation of valid OEM warranty support.

General Info

Sole-source award to Bio Fire Defense for diagnostic kits and systems in Italy.

NAICS

325413 - In-Vitro Diagnostic Substance Manufacturing

Place of Performance

CATANIA, AE, 95040, ITA

Set-Aside

NONE

Documents

1

Draft Statement of Work for Bio Fire Kits - NAMRU EURAFCENT

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Timeline

PhaseClosed
Posted

Presolicitation

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Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Defense → Navsup Flc Sigonella Naples Office
Contacts2 people available
OfficeFPO, AE, 09622-0050, USA
Office AddressFPO, AE, 09622-0050, USA
Contacts

Full Description

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PRESOLICITATION NOTICE


Notice Number: N6817126QN076


Subject: Procurement of BioFire Diagnostic Assay Kits and Refurbished Systems


Product Service Code (PSC): 6550 — In Vitro Diagnostic Substances, Reagents, Test Kits and Sets


NAICS Code: 325413 — In-Vitro Diagnostic Substance Manufacturing


Contracting Office: NAVSUP Fleet Logistics Center Sigonella (FLCSI) — Naples, Italy


Points of Contact:


Maria Saggese            maria.saggese.ln@us.navy.mil


Patricia Folts               patricia.r.folts.civ@us.navy.mil



1. INTRODUCTION


The Naval Supply Systems Command (NAVSUP) Fleet Logistics Center Sigonella (FLCSI) provides notification of its intent to award a firm-fixed-price sole-source purchase order to Bio Fire Defense, LLC (CAGE: 1Y6K1), located at 1201 Foothill Dr, Salt Lake City, UT 84108-1418.


The contract will support the Naval Medical Research Unit Europe, Africa, Central (NAMRU EURAFCENT) in its execution of the Department of War (DoW) Global Emerging Infections Surveillance (GEIS) program and active infectious disease surveillance and research operations across Europe, Africa, and the Middle East.


2. REQUIREMENT DESCRIPTION


The government requires the procurement of commercial-off-the-shelf (COTS) proprietary BioFire assay kits and refurbished FilmArray 2.0 systems. The specific required items and quantities are:


  • BioFire Global Fever Special Pathogens Panel IVD, 6 Tests (Quantity: 14)
  • Blood Culture Identification Panel 2 IVD, 30 Tests (Quantity: 2)
  • FilmArray NGDS Sentinel Panel v3.0, 30 Tests (Quantity: 4)
  • Food & Water Panel, 30 Tests (Quantity: 5)
  • Gastrointestinal Panel IVD, 30 Tests (Quantity: 4)
  • Meningitis/Encephalitis Panel IVD, 30 Tests (Quantity: 2)
  • Respiratory Panel 2.1 IVD, 30 Tests (Quantity: 6)
  • FilmArray 2.0 (Refurbished) Complete Configured System with Laptop and Hard Case (Quantity: 4)

Delivery Terms: Destination delivery to NAMRU-EURAFCENT on NAS II Sigonella, Italy, NLT 15 calendar days after receipt of order (ARO).


3. SOLE SOURCE RATIONALE


The required assay kits are proprietary consumables engineered, patented, and validated by the parent manufacturer (bioMérieux) for exclusive use on the 12 existing BioFire FilmArray platforms currently operated by NAMRU EURAFCENT. The use of non-OEM consumables would void equipment warranties and compromise active diagnostic validation protocols.


Furthermore, under a formalized Foreign Ownership, Control, or Influence (FOCI) mitigation agreement established between the United States Government and bioMérieux, direct sales of these strategic biological defense assets (such as the Next Generation Diagnostic System / NGDS Sentinel Panel) to U.S. Federal Government entities are restricted. Under the terms of this agreement, all U.S. Federal Government accounts—specifically including the Department of War—must procure these diagnostic materials and systems exclusively through the U.S.-based, wholly-owned subsidiary, Bio Fire Defense, LLC. There are no other authorized federal distributors or dealers permitted to fulfill these accounts under the security agreement.


4. INSTRUCTIONS TO INTERESTED PARTIES


This acquisition is being conducted under the authority of FAR Part 12. This is a notice of intent and does not constitute a request for competitive proposals. However, all responsible sources that believe they can meet the Government's requirement may submit a capability statement.


To be considered responsive and capable, any submitted capability statement must provide clear and convincing evidence of the following:


FOCI Agreement Compliance: Written evidence from the parent manufacturer (bioMérieux) confirming that the responding company is an authorized U.S. federal representative and is legally cleared to sell, distribute, and support these systems under the terms of the active U.S. Government FOCI mitigation agreement.


Exact Configuration Match: Confirmation that the responding company can provide the exact Bio Fire part numbers and models as listed in Section 2 above, with no substitutions, to preserve biological protocol validation on existing platforms.


Delivery Capabilities: A clear description of the company's logistical capability to secure and deliver biological materials (requiring cold-chain integrity, where applicable) to NAS II Sigonella, Italy within fifteen (15) calendar days after contract award.


Warranty Support: Confirmation that the standard OEM manufacturer's warranty and technical support will be fully valid, recognized, and honored for the equipment and panels delivered to NAMRU EURAFCENT.


All capability statements must be received no later than 31 August 2026 at 10:00AM Central European Time (CET). Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.


A determination by the Government not to compete this proposed commercial contract based upon responses to this notice is solely within the administrative discretion of the Contracting Officer. The Government will not compensate interested parties for any costs related to the preparation or submission of a capability statement.


Please submit any responses or capability statements via email to:


maria.saggese.ln@us.navy.mil


patricia.r.folts.civ@us.navy.mil


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