Single Source Justification MPT to SAT - Cobas 6800 HPV Reagents_Redacted.pdf
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- Attached to
- 6640--Cobas 6800 HPV Reagents
- Solicitation number
- 36C24226Q0922
About this file
Single Source Justification for Sole Source Award
This is a Single Source Justification document for a simplified acquisition procedure submitted by the Department of Veterans Affairs, VISN 02, on behalf of the Buffalo VA Medical Center (VAMC). The acquisition plan action ID is 36C242-27-AP-0185, with a 2237 number of 528-27-1-4307-0002.
The Buffalo VAMC requires Cobas 6800 HPV reagents and associated consumables to perform HPV testing using its existing Cobas 6800 instrument. The estimated dollar value is redacted in the document. Required supplies include 16 distinct product lines with specified annual quantities, including HPV test kits (480T IVD at 5 kits/year), RMC IVD kits (6 kits/year), BUFF NEG RMC IVD (7 kits/year), PCR media tubes and caps, amplification and processing plates, LYS reagent IVD (4 kits/year), MGP IVD (8 kits/year), SPEC DIL RGNT IVD (3 kits/year), WASH IVD (12 kits/year), UTL CHAN 192t IVD (4 kits/year), and UC-TIB C.AURIS (4 kits/year). All products are manufactured exclusively by Roche Diagnostics.
The Cobas 6800 system operates as a closed, fully integrated diagnostic platform designed to function solely with Roche-certified reagents, cartridges, and consumables. The instrument's software, onboard storage, and refrigeration are engineered to recognize only Roche-proprietary products, and consumables feature unique physical design elements such as a single beveled edge essential for proper placement and assay performance. Use of non-Roche reagents would violate the closed-system design, resulting in assay failure, data integrity concerns, and test validity risks. Market research conducted in July 2026 included an OEM quote and sole source letter from Roche Diagnostics. Searches of the SBA Small Business Search database, VA's ADDS UP system, and SAM identified 117, 117, and 31 contract actions respectively, with 116, 116, and 30 awarded to Roche Diagnostics. The contracting officer, Jonathan Kilgore, certified the justification as accurate on August 5, 2026, approving the purchase in accordance with RFO FAR 12.201-1.
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| File | Type | Posted |
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| 36C24226Q0922_1.docx | DOCX document |
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VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for MPT up to SAT
Acquisition ID# 36C242-27-AP-0185
3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:
The Buffalo VA Medical Center requires Cobas 6800 HPV reagents and associated consumables to perform HPV testing using the existing Cobas 6800 instrument owned and operated by the facility. These reagents and supplies are proprietary products manufactured exclusively by Roche Diagnostics.
The Cobas 6800 system is designed as a closed, fully integrated diagnostic platform that operates solely with Roche-certified reagents, cartridges, and consumables. Per Roche Diagnostics, the instrument’s onboard storage, refrigeration, and automated processing software are engineered to recognize and manage only Roche-proprietary cassettes and bottles. All consumables used with the Cobas 6800 include unique physical design features, such as a single beveled edge for proper placement and alignment, that are essential to correct loading, instrument recognition, and assay performance.
Use of non-Roche reagents or consumables would violate the instrument’s closed-system design, resulting in assay failure, data integrity concerns, and risk to test validity. No other manufacturer produces reagents or consumables compatible with the Cobas 6800 platform.
Because Roche Diagnostics is the sole manufacturer and sole authorized source for Cobas 6800 HPV reagents and supplies, these items are only available directly from Roche. Therefore, procurement of these proprietary materials must be conducted as a sole source acquisition to ensure reliable operation of the Cobas 6800 instrument and continuity of HPV testing services at the Buffalo VAMC.
4. Description of market research conducted and results or statement why it was not conducted:
Market research was conducted in July of 2026.
Requirements package included a quote from the OEM Roche Diagnostics Corporation as well as a sole source letter stating they are the sole manufacturer and distributor of the Cobas 6800 System and all assays, reagents and consumables used with the system.
A search of SBA’s Small Business Search using keywords “cobas 6800” and NIACS code 334516 returned zero results.
A search of VA’s ADDS UP using keywords “cobas 6800” and NAICs code 334516 identified 117 relevant contract actions. 116 of these were awarded to Roche Diagnostics and the remaining action was awarded to Exact Diagnostics, LLC, which is no longer active in SAM and has been acquired by Bio-Rad Laboratories.
VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for MPT up to SAT
Acquisition ID# 36C242-27-AP-0185
A search of SAM using keywords “Cobas 6800” and NAICS code 334516 identified 31 awarded contract actions. 30 of these were awarded to Roche Diagnostics and the remaining action was awarded to Exact Diagnostics.
Based on the market research findings above, there’s no expectation that any Small Business, including SD/VOSBs, can meet the Government's requirements. CO recommends pursuing a sole source award with Roche Diagnostics, who is the OEM and only distributor of the required products.
5. Contracting Officer's Certification: Purchase is approved in accordance with RFO
FAR 12.201-1. I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.
Jonathan Kilgore Date Contracting Officer
JONATHAN
KILGORE
Digitally signed by JONATHAN
KILGORE
Date: 2026.08.05 16:27:56 -04'00'
File details come from the government source that posted it. Updated .