Vela Diagnostics Sequencing System for HIV-1 Genotype Testingview on SAM.gov

Notice of Intent (NOI) to Sole Source Title: Vela Sentosa SQ Next Generation Sequencing (NGS) for FDA Approved HIV-1 Genotype Sequencing Requiring Activity: Walter Reed Army Institute of Research (WRAIR) , Diagnostics and Countermeasures Branch (DCB) Related Notice: HT9426-26-RFI-5892 Product Service Code (PSC): 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets North American Industry Classification System (NAICS) Code: 325413 - In-Vitro Diagnostic Substance Manufacturing Small Business Size Standard : 1250 employees The Defense Health Agency Contracting Activity (DHACA) on behalf of the Diagnostics and Countermeasures Branch (DCB) at the Walter Reed Army Institute of Research (WRAIR) intends to award a Firm Fixed Price contract on a sole source basis to Vela Diagnostics, USA INC; 353C US Highway 46; STE 250; Fairfield, New Jersey 07004; Cage Code 86YT5 under the RFO FAR 6.103-1 – Only one responsible source can supply the required products, and no other type of supplies or services will satisfy requirements. Description of Services: Via a reagent rental agreement, the contractor shall provide all Sentosa sequencer kits, consumables, supplies, sequencing systems and sub-components, and maintenance and repair. The HIV Diagnostics and Reference Lab (HDRL), DCB at the WRAIR currently utilizes the Sentosa SQ Next Generation Sequencing (NGS) system in order to perform HIV genotype testing which is critical for the monitoring of drug resistance mutations in HIV-1 infected soldiers and their beneficiaries. The Sentosa NGS system includes instrumentation and reagents required to perform the Vela Sentosa SQ HIV-1 Genotype test in a College of American Pathologist (CAP) accredited laboratory. As the system and assay is Food and Drug Administration (FDA) approved, clinical testing laboratories are required to use the instruments and reagents approved by the FDA in the execution of the test. Market Research was conducted and indicated similar products from other companies cannot meet or be modified to meet the Government's requirements. Additionally, this contract requires a reagent rental agreement between the manufacturer and the Government. Vela has confirmed that authorized third party vendors of Vela products are not authorized to offer this agreement; ergo, the requirements of this contract can only be met by Vela. This special notice of intent is not a request for competitive proposals, and no solicitation document exists for this requirement. Meaningful submissions received in response to this notice will be considered solely for the purpose of determining whether a competitive procurement is in the best interest of the Government. If no meaningful, written submissions are received by the date listed below, after the publication of this notice, the solicitation will be issued as a sole source requirement to Vela Diagnostics, USA INC. Based on the above information, the only technically acceptable vendor to fulfill t…