70-U6900-26-CP314_072726 Ventana Medical Systems, Inc. (Roche) SS.pdf.PDF

UNM Proposed Sole Source Form – Rev 04/07/2021

Proposed Sole Source Purchase Form Pursuant to New Mexico Procurement law, the UNM Purchasing Department will post your completed form on the UNM Sunshine

Portal and the State of New Mexico Procurement website for 30 days prior to purchase of the goods/services.

I. GENERAL INFORMATION. PLEASE PROVIDE THE FOLLOWING:

Date of Request Requisition Number (If Applicable) Request Submitted by: Title

Department Email Phone Proposed Vendor Amount

Vendor Address Term of Purchase

Buyer Team - See Commodity list at http://purchase.unm.edu/department-information/comm-code-listing.pdf Provide a basic description of goods/services to be provided:

Why is this purchase needed?

II. BASIS FOR SOLE SOURCE PROCUREMENT. CHOOSE APPLICABLE BOX(ES) AND

PROVIDE ADDITIONAL INFORMATION, AS REQUESTED:

☐ Proprietary item, technology or service only available from the proposed vendor. (Check box and describe proprietary component)

July 21, 2026 Nancy Joste, MD, MS

Pathology/Human Tissue Repository NJoste@salud.unm.edu 2-5407 Ventana Medical Systems, Inc. (Roche)

Director

The requested instrument is a new Ventana Discovery Ultra Automated Slide Staining System, an advanced automated platform for immunohistochemistry (IHC), in situ hybridization (ISH), multiplex immunohistochemistry, and immunofluorescence staining of tissue specimens.

The current instrument in our laboratory, purchased in 2014, is now over 10 years old and approaching the end of its expected service life. Replacement of this instrument is essential to maintain reliable research operations, support collaborative research programs across the University of New Mexico Health Sciences Center (UNM HSC), and enable investigators to pursue competitive extramural funding.

1910 Innovation Park Drive, Oro Valley, AZ 85755 $249.794

One-time capital equipment purchase with one-year warranty and five-year service agreement http://purchase.unm.edu/department-information/comm-code-listing.pdf

☐ Compatibility requirement with existing item, technology or service. (Check box and describe compatibility requirement)

☐ Renewal of support/maintenance/subscription of software, technology or other intellectual property. (Check box and describe)

☐ Other Basis for Sole Source: Please describe below:

III. SUPPLEMENTAL DETAILS. PLEASE PROVIDE ADDITIONAL INFORMATION AS

REQUESTED BELOW:

Describe in detail the unique capabilities of the proposed vendor’s goods/service and/or personnel performing the work and why this constitutes the only source. Focus on what is unique about the goods/service and why no other vendor could meet your needs.

This request is based on the need to maintain continuity of established research protocols, preserve reproducibility of ongoing studies, and protect the substantial institutional investment made over the past twelve years in assay development and validation. Since implementation of the current system in 2014, the HTR has developed and validated more than 125 IHC protocols, produced over 8,000 slides, and supported more than 40 investigators across the UNM HSC. These protocols have been optimized specifically for the Ventana Discovery Ultra hardware, software, reagents and workflow.

Replacement with a different manufacturer's platform would require extensive redevelopment and revalidation of existing protocols, including optimization of antibody concentrations, antigen retrieval conditions, detection chemistries, incubation parameters, and quality control procedures. This process would require significant personnel time and reagent costs while introducing variability into ongoing studies, potentially compromising the comparability of new data with previously generated results. Many active research projects rely on longitudinal analyses for which reproducibility and methodological consistency are essential. Maintaining the same instrumentation platform allows existing validated protocols to be transferred to the replacement instrument with only minimal verification and adjustment, rather than complete redevelopment and revalidation. This preserves data integrity, minimizes downtime, and avoids unnecessary duplication of effort and expense. For these reasons, the Roche Ventana Discovery Ultra is the only system that meets the technical and operational requirements necessary to support the Human Tissue Repository's ongoing research mission.

UNM Proposed Sole Source Form – Rev 04/07/2021

Replacement of an existing research platform to maintain validated protocols, scientific reproducibility, and continuity of ongoing funded research.

UNM Proposed Sole Source Form – Rev 04/07/2021

Describe the due diligence made to locate other possible sources including communications with other universities, communications with similar providers, web searches, yellow page searches, review of advertisements and trade publications, etc.

List the other vendors who were contacted. Please describe the specs/qualifications/criteria that the other vendors were unable to satisfy.

The Human Tissue Repository evaluated the availability of alternative automated immunohistochemistry (IHC) staining platforms capable of providing similar functionality. While other manufacturers produce automated IHC instrumentation, including systems from Leica Biosystems and Agilent/Dako, these platforms utilize different hardware designs, proprietary software, reagent chemistries, detection systems, and staining workflows. As a result, protocols developed and validated on the Roche Ventana Discovery Ultra are not directly transferable to these alternative systems.

Because the requested equipment is a direct replacement of an existing Roche Ventana Discovery Ultra system, procurement of the same platform is the only option that preserves validated methods, ensures continuity of ongoing funded research, minimizes downtime, and protects the University's substantial investment in assay development. Based on this evaluation, no other commercially available platform can provide an equivalent replacement while maintaining compatibility with the HTR's validated methods, existing protocols, and ongoing funded research.

Comparison using data available on-line demonstrates the following:

Vendor/Instrument Meets Compatibility Requirements? Reason Roche/Discovery Ultra Yes

Leica/BOND RX No

Agilent/Dako/Omnis No

Direct replacement; existing validated protocols transfer with minimal modification

Requires complete revalidation of protocols and uses different reagents and software

Different staining chemistry, workflow, and protocol architecture; historical comparability cannot be maintained