P03 10x SingleSourceJustification - Printed_Redacted.pdf

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 1 of 2 Original Date: 08/30/17 Revision 01 Eff Date: 04/23/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID:_ Planning UID: VA-25-00088386

1. Contracting Activity: Department of Veterans Affairs, VISN 4, VA Pittsburgh Medical Center

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

Product Quantity Cost GEM-X Flex Sample Preparation v2 Kit

GEM-X Flex Gene Expression Chip Kit, 4 chips

Dual Index Kit TS Set A, 96 rxn

GEM-X Flex Gene Expression Human 16-plex, 64 samples

Total Est Cost

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

10X Genomics, Inc is the exclusive manufacturer of these products. The 10x platform allows for full transcriptional analysis at the single cell level, single-cell RNA sequencing, in formalin fixed paraffin embedded (FFPE) tissues. This technology is essential to study preserved samples from Gulf War Veterans. Costs will be reduced by conducting essential first steps, cell isolation and library preparation at the Pittsburgh VA Healthcare System. Additionally, the 10x platform is the only automated commercial product that allows for sample multiplexing facilitating analysis of multiple patient samples per each run, dramatically reducing reagent and personnel costs. Spec sheet and sole source documentation will be included in the file that includes all products 10X Genomics exclusively manufactures as well as represents their patents and patent applications.

What sets 10x apart is that no other commercial platform is capable of conducting this analysis on FFPE tissues which are the standard preservation method for samples from Veteran patients. The 10x platform combines probe-based hybridization chemistry with high-throughput single-nucleus barcoding for FFPE-derived samples. This allows us to analyze Veteran samples that have been collected over many years. Competing technologies either require the use of fresh tissues, analyzed within 2 hours, or focus on bulk profiling, not at the single cell level. Thus, 10x Genomics remains the only automated commercial platform that enables single-nucleus transcriptomic profiling from FFPE tissues at true single-cell scale.

4. Description of market research conducted and results or statement why it was not conducted:

Market research is not able to be conducted as 10X Genomics, Inc are the only manufacturer of automated, single cell RNA sequencing platforms capable of analyzing FFPE biologic samples. Alternative

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 2 of 2 Original Date: 08/30/17 Revision 01 Eff Date: 04/23/2018 systems are incompatible with these preserved Veteran tissues and would not fulfill the aims of the research on Gulf War Veterans. As such, there are no like products to compare.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Name Date Title

ANDREA

AULTMAN-SMITH

Digitally signed by ANDREA

AULTMAN-SMITH

Date: 2025.08.06 14:02:05 -04'00'