Vela Diagnostics Sequencing System for HIV-1 Genotype Testing

Description

Request for Information (RFI) /Sources Sought (SS) Notice RFI Number: HT9426-26-RFI-5892 Requiring Activity Name: The Walter Reed Army Institute of Research (WRAIR) Contracting Office: Defense Health Agency Contacting Activity (DHACA) Subject: WRAIR has a need for a Vela Diagnostics sequencing system (Brand name only) for HIV-1 genotype testing to include all required sub-system components, maintenance and repair, and operational supplies and consumable products. Place of Performance or Delivery: Silver Spring, MD 20910 General Information: In accordance with Revolutionary FAR Overhaul (RFO) 15.101; Exchange with industry before receipt of proposals, this Sources Sought is for information and planning purposes only and at this time shall not be construed as a solicitation or as an obligation or commitment on the part of the Government nor will the Government pay for information solicited. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are advised that the United States Government will not pay for any information or administrative costs incurred in response to this RFI. All costs associated with responding to this RFI/SS will be solely at the interested responder�s expense. Not responding to this RFI/SS does not preclude participation in any future Request for Proposal, if any is issued. No evaluation letters and/or results will be issued to Responders responding to this RFI/SS. This Sources Sought Notice is a Market Research tool used to determine the availability and adequacy of potential sources, prior to determining the method of acquisition and issuance of a solicitation. The NAICS code for this requirement is: 325413 - In-Vitro Diagnostic Substance Manufacturing DISCLAIMER: This Request for Information (RFI)/Sources Sought (SS) Notice is NOT a Request for Proposals (RFP) or a Request for Quotations (RFQ). This RFI is issued solely for market research information and planning purposes only and does not constitute a solicitation. Responses to the RFI will not be returned. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. No contract will be awarded from this announcement. No reimbursement will be made of any costs to provide information in response to this announcement or any follow-up information requests; responders are solely responsible for all expenses associated with responding to this RFI. Availability of any formal solicitation will be announced under a separate announcement. All information received in response to this RFI will be treated as confidential business information. Submitters should properly mark their responses if the information is confidential. All information received in response to this RFI that is marked Proprietary, will be handled accordingly. At this time, questions concerning the composition and requirements for future solicitation will not be entertained. RFI Response and due date: 11:00am EST on 09 July 2026 Instructions to Responders: Responses from all capable and qualified sources are encouraged to respond to this request. Review the attached Minimum Essential Characteristics (MECs) . Respondents should address how they best can fulfil the requirements set forth in the MECs in their capabilities statement. Capability Statements or any other proprietary information relative to this RFI should adhere to the following formatting and outline instructions: White papers should adhere to the following formatting and outline instructions: 1. All submissions shall be made electronically and be in one of the following formats: Microsoft Word or Adobe PDF. 2. Cover Page (1page) Title Organization Responders technical and administrative points of contact (names, addresses, phone, fax number and email addresses) Topic area(s) addressed Respondents shall be registered in www.sam.gov under the NAICS code of 325413 System for Award Management (SAM.gov) Unique Entity ID (UEI) List all ordering vehicles held by respondents in which you are an authorized third-party vendor. Please include associated contract numbers (e.g. OMNIBUS IV,CHESS, GSA, etc.) 3. Interested parties are asked to respond to this RFI and submit a capabilities statement that supports the focus of this RFI. Please review the place of performance requirements. Please submit written responses via email in Microsoft Office 2000 or later format. All responses should be complete: in 12-point font; and not to exceed 3 pages total, including graphics, tables, and appendices. Response shall address whether the respondent is offering similar or like supplies/services in the commercial market to the general public. Please note that the response shall provide sufficient technical data to determine how you fully meet the requirements as specified in the MECs. The requested information shall be submitted by the date and time specified above, via email, to the Contract Specialist Brenda Mena at email: brenda.i.mena.civ@health.mil and Contracting Officer, Lance Nowell at email: lance.l.nowell.civ@health.mil. Only electronic responses will be accepted. No evaluation letters and/or results will be issued to the respondents. Currently no solicitation exists; therefore, a copy of the solicitation cannot be provided. Telephone requests will not be honored, and no bidders list shall be maintained. No inquiries regarding any potential future acquisition activities shall be entertained. BACKGROUND This requirement is for Vela Sentosa sequencer kits, consumables, supplies, sequencing systems and sub-components, and maintenance and repair (name brand only) for HIV-1 genotype testing as specified in the Minimum Essential Characteristics (MECs). The HIV Diagnostics and Reference Lab (HDRL), Diagnostics and Countermeasures Branch (DCB) at the Walter Reed Army Institute of Research (WRAIR) currently utilizes the Vela 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 Vela 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.