BD Viper

This is a sources sought announcement only. This is not a solicitation for proposals and no contract will be award from this announcement. The purpose of this announcement is to perform market research to gain knowledge of potential qualified sources and their size classification relative to NAICS 334516, Analytical Laboratory Instrument Manufacturing with a size standard 1,000 employees. The VHA Network Contracting Office (NCO) 16 Houston, TX is seeking to identify any vendor capable of providing the BD Viper LT System for Onclarity HPV Self-Collect Testing. The Veterans Health Care System of the Ozarks Pathology and Laboratory Medicine Service (PLMS) department, in collaboration with the Women s Health Innovation and Staffing Enhancements (WHISE) are performing in vitro diagnostic (IVD) testing that can detect DNA from 14 high risk human papillomavirus (HR HPV) types that are associated with cervical cancer from specimens that are self-collected by the patient. The role of market research is an essential element of building an effective strategy for the acquisition of IVD testing, the following salient characteristics must be provided in response to this sources sought. Salient characteristics and/or performance objectives sought: A compact, integrated, self-contained table-top system that automates sample extraction and real-time PCR for extended genotyping. The system shall include the automation of sample preparation, DNA extraction, amplification, detection, and result interpretation. The assay must be capable of qualitative detection of the following 14 high-risk HPV Individual Extended Genotypes callouts for 16,18,31,45,51,52 and pooled groups of (33,58), (35,39,68) and (56,59,66). Assay must follow ASCP management pathway guidelines, grouping genotypes 56, 59 & 66. Assay must be capable of targeting the E6/E7 region. Must be capable of approval for the following testing methods: Primary Screening, Co-Testing and Reflex testing. Assay must feature Internal cellularity control. Must have FDA Clearance for both ThinPrep and SurePath Liquid Based Cytology All software must be configured to communicate with existing LIS and transmit results automatically. The fully operational interface (both hardware and software) must be immediately available for implementation to the VA VistA hospital information system The analyzer must be capable of returning 90 to 120 results per day. The analyzer must have walk-away capabilities. The analyzer must be supported by an uninterruptible power supply provided by the vendor. All components of the system, to include the software, approved by the FDA. The analyzer must be capable of running patient-collected specimens. Also known as self-collect . The specimen collection kit should be easy to use, requiring no reagent prep, mixing, and must be stable at room temperature. All reagents must be stable at room temperature, requiring no refrigeration or freezing maintain viability. Responses to this sources sought must include the following information: 1. Your company name, address, contact person name, phone number, fax number, e-mail address(s) and ueiSAM number (i.e. LV91LJ4B1Z98), and company website if available. 2. Your company GSA/FSS contract number if available. 3. Socio-economic status of the business (i.e. SDVOSB/VOSB, 8(a), HUB Zone, Women Owned Small Business, Small disadvantaged business, or Small Business HUB Zone business) 4. Capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capabilities are sought. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements. 5. Vendors are requested to submit estimated market research pricing with their responses. The estimated pricing will be considered when determining a procurement strategy for the future requirements. 6. Notice of Intent to Sole Source. The current procurement strategy is an Unrestricted competitive solicitation until determined after the close of this notice. If there are no responses to this notice, a determination by the Government not to compete based upon responses to this notice is solely within the discretion of the Government. No response is a response. Interested vendor should submit an email to troy.davis@va.gov. All responses must be received in writing no later than 12:00 PM CST/local time on March 7, 2025 and shall include all necessary documentation on the ability to satisfy the Government s requirements. Vague or incomplete submissions of capabilities will be considered dated, inaccurate, and irrelevant information and will not be used in the development of any acquisition plan or procurement strategy. Questions or inquiries will not be answered or acknowledged, and no feedback will be provided. This is not a solicitation and there is no solicitation document available at this time. DISCLAIMER: This notice is issued solely for informational and planning purposes and does not constitute a solicitation. Responses to this notice are not offers and cannot be accepted by the Department of Veterans Affairs to form a binding contract. Respondents are solely responsible for all expenses associated with responding to this notice.

Background
The Veterans Health Administration (VHA) Network Contracting Office (NCO) 16, located in Houston, TX, is conducting market research to identify potential vendors capable of providing the BD Viper LT System for Onclarity HPV Self-Collect Testing. This initiative is part of the Veterans Health Care System of the Ozarks' Pathology and Laboratory Medicine Service (PLMS) department, which collaborates with the Women’s Health Innovation and Staffing Enhancements (WHISE) to perform in vitro diagnostic (IVD) testing for high-risk human papillomavirus (HR HPV) types associated with cervical cancer. The goal is to enhance the acquisition strategy for IVD testing by gathering information on qualified sources and their capabilities.

Work Details
The contract seeks a compact, integrated, self-contained table-top system that automates sample extraction and real-time PCR for extended genotyping. The salient characteristics include:

- Automation of sample preparation, DNA extraction, amplification, detection, and result interpretation.
- Capability for qualitative detection of 14 high-risk HPV genotypes: 16, 18, 31, 45, 51, 52 and pooled groups of (33,58), (35,39,68), and (56,59,66).
- Compliance with ASCP management pathway guidelines for grouping genotypes 56, 59 & 66.
- Targeting of the E6/E7 region.
- Approval for Primary Screening, Co-Testing and Reflex testing methods.
- Internal cellularity control feature.
- FDA Clearance for ThinPrep and SurePath Liquid Based Cytology.
- Software must communicate with existing Laboratory Information Systems (LIS) and transmit results automatically.
- Analyzer must return 90 to 120 results per day with walk-away capabilities.
- Supported by an uninterruptible power supply provided by the vendor.
- Capable of running patient-collected specimens ('self-collect').
- Specimen collection kit must be easy to use without reagent prep or mixing and stable at room temperature. All reagents must maintain viability without refrigeration or freezing.

Period of Performance
Responses are due by March 7, 2025.

Place of Performance
Department of Veterans Affairs Network Contracting Office 16, Houston TX.