Procurement of commercial-off-the-shelf (COTS) proprietary BioFire diagnostic assay kits and refurbished systemsview on SAM.gov

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…