Notice Of Intent To Sole Source For Electrochemiluminescence Analyzers And Consumables

special notice

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This is a notice of intent, and not a solicitation, for the Department of the Army to award a sole?source, Firm?Fixed?Price (FFP) Indefinite Delivery Indefinite Quantity (IDIQ) contract vehicle to: Meso Scale Diagnostics, LLC (CAGE: 1ZHK4) 16020 Industrial Drive Gaithersburg, MD 20877-1424 The statutory authority for this sole?source procurement is 41 U.S.C. § 1901, as implemented by FAR 13.501(a)(1)(ii), Sole source acquisition under simplified acquisition procedures for certain commercial items. The Government intends to award a single?award IDIQ contract with a five?year ordering period for the continued supply of Electrochemiluminescence (ECL) analyzers and associated proprietary consumables in support of biological reconnaissance and surveillance missions. The current estimated value of this action is approximately $9,000,000.00. The requirement includes: ECL analyzers (specifically, the Meso Scale Diagnostics (MSD) SQ120 BT analyzer, the designated replacement for the obsolescence MSD PR2 1800 system); Proprietary immunoassay kits, reagents, and related consumables; and Associated software, licensing, and support necessary for system operation. The Government’s minimum needs include a commercially available platform that: Is compatible with Government?validated assays for Staphylococcal enterotoxin B, Botulinum toxin, and Ricin toxin; Can be operated safely in the intended mobile laboratory environment without reliance on a primary engineering control (e.g., a biological safety cabinet) for routine analyzer operation; Is compatible with the currently fielded MSD analyzer workflow and associated proprietary consumables/software architecture; and Supports continuity of operations, training, and logistics for the existing user base. Market research conducted in FY 26 evaluated commercially available ECL?based immunoassay systems and confirmed that, while multiple vendors manufacture ECL analyzers, only MSD’s technology incorporates the sealed?plate reading capability necessary for safe operation outside primary engineering controls in space?constrained mobile laboratories. Other systems rely on liquid handling mechanisms that create unacceptable aerosolization risks when analyzing samples containing biological toxins, making them unsuitable for use in mobile laboratory environments where primary engineering controls cannot accommodate the analyzer equipment. Based on the Government’s current market research, MSD is the only known source capable of providing a commercially available platform and proprietary consumables that satisfy the Government’s minimum needs without unacceptable technical, validation, safety, interoperability, and schedule risk. MSD controls the relevant analyzer software architecture and proprietary consumables used with the fielded MSD platform. Use of an alternative platform would require additional verification and validation activities, new qualification efforts, and transition actions (including retraining and logistics changes) that the Government does not currently consider practicable for this requirement. This notice is issued for informational purposes only to identify any responsible sources that can meet the Government’s minimum needs. This notice is not a request for quotations or proposals. Interested sources may submit a capability statement only. The Government will consider all timely capability statements received solely for the purpose of determining whether to conduct a competitive procurement in the future or to proceed with the intended sole?source award. A determination by the Government not to complete this proposed contract based on responses to this notice is solely within the discretion of the Government. CAPABILITY STATEMENT REQUIREMENTS Interested parties must provide clear and convincing evidence that they can meet the Government’s minimum needs identified above. At a minimum, the capability statement should include: Company name, address, CAGE code, and primary point of contact. A detailed description of the proposed analytical system and its technical specifications. Evidence demonstrating compatibility with Government?validated assays for Staphylococcal enterotoxin B, Botulinum toxin, and Ricin toxin, or a detailed explanation of how such compatibility would be established without unacceptable disruption, delay, or additional Government burden. Data or other evidence demonstrates that the proposed system can be operated safely in the intended mobile laboratory environment without reliance on a primary engineering control for routine analyzer operation, including discussion of aerosolization or other operator safety risks during routine use. A description of required consumables, software, licensing, and any proprietary features or restrictions associated with operation of the proposed system. A discussion of interoperability, transition impacts, training impacts, validation requirements, and schedule considerations associated with replacing or supplementing the currently fielded MSD platform.

United States of America (USA)

Maryland

SAM.gov

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