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

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 (bioM rieux) 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 bioM rieux, 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 (bioM rieux) 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