OFOC Infinity Biologix Long Read 36C24E-25-AP-0393 Page 2 of 5 research studies, providing deeper insights into genomic research and contributing to a better understanding of complex diseases, treatment responses, and overall Veteran health. The data is currently being actively used by over 131 research teams to investigate various diseases affecting the Veterans. The continued success of the study necessitates continuity in current processes and protocols that allows for batch variation being kept below 1% to maintain the statistical prediction power of the MVP data as a single cohort.

These services are essential to maintaining the continuity of research efforts and advancing the scientific objectives of the MVP program. As new samples continuously arrive from Veterans, these services play a pivotal role in constructing comprehensive genomic mappings for Veterans, which can lead to the development of targeted therapies. Without these services, or in the event of any delays, the opportunity to provide Veterans with these targeted treatments could be lost. Furthermore, the inability to utilize samples from specific, smaller subsets of the Veteran population could hinder research efforts and delay the discovery of important findings. Ensuring the seamless availability and execution of these assay services is therefore essential for advancing personalized medicine and optimizing health outcomes for Veterans.

This is a continuation of contract 36C24E20D0028 and ensures consistency in assay specificity and reproducibility, data quality, methodology, and ongoing research integrity critical to the program�s success enabling the efficient implementation for clinical care of the Veterans. for the Million Veteran Program (MVP) under the Genomic Medicine Program (GMP).

The anticipated value for this requirement is for a ceiling of as shown below

4. Statutory Authority Permitting Other than Full and Open Competition:

( X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.103-1;

5. Demonstration that the Contractor�s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The selected Contractor is Infinity Biologix LLC, 30 Knightsbridge Road, Building 3, Piscataway, New Jersey 08854.

This requirement is for high-throughput long-read sequencing, proteomics, and peptide-level molecular assays specifically tailored to Veteran sample processing under VA Office of Research and Development (ORD) Center for Data and Computational Sciences (C-DACS). C-DACS requires a contractor with demonstrated, reliable, and validated capability to handle over 300,000 samples across long-read sequencing and proteomic platforms while maintaining the strictest standards for biospecimen security, assay reproducibility, and metadata-enriched data delivery.

The contractor has been an established partner to C-DACS and has co-developed, validated, and operationalized custom long-read sequencing and proteomic workflows capable of supporting single-molecule read lengths exceeding 10,000 bp, delivering >97% variant call rate and >99% reproducibility for Veteran samples. On the proteomics front, the contractor operates a commercial assay platform that consistently detects >3000 common proteins with input volumes of <10

OFOC Infinity Biologix Long Read 36C24E-25-AP-0393 Page 3 of 5

L/sample, achieving >97% QC pass rate and >99% reproducibility at batch scales of over 300 samples.

This vendor uniquely integrates their automated laboratory workflows, advanced Laboratory Information Management System (LIMS) capabilities, and regulatory infrastructure (including Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP), and Health Insurance Portability and Accountability Act (HIPAA) compliance) to deliver high-throughput sample processing and data return in line with VA project SLAs. They maintain a fully auditable chain-of-custody and secure data management environment designed for genomic and proteomic assays. Their experience processing Veteran biospecimens in both long-read sequencing and proteomics under prior agreements ensures familiarity with VA metadata standards, QC pipelines, encryption protocols, and delivery formats.

The contractor�s infrastructure, SOPs, and IT controls are already validated by C-DACS and tailored to VA requirements. This includes emergency power-backed biorepositories, LIMS-based audit trails with 48-hour response SLA, and automated reporting of data quality and manifest logs per drive. The contractor has delivered end-to-end support for C-DACS sample processing, from physical receipt and chain-of-custody through bioinformatic transformation into standardized and richly annotated data products.

Maintaining continuity with this contractor is critical. Transitioning to a new vendor would require re-development and validation of all assay and data generation pipelines, involving approximately 10,000 hours of lab and data science effort across a full year. Additional onboarding and coordination effort from VA staff would exceed 100 hours, not including project re-initiation delays. Sample reruns due to new pipeline inconsistencies could result in costs of per batch, not including the risk of unrecoverable samples. Switching vendors would also jeopardize batch-to-batch continuity required for downstream study integrity, particularly in the analysis of rare protein variants and complex structural variants in the Veteran population.

Given the volume, specificity, and timeline of ongoing VA research projects, including longitudinal efforts involving rare and high-risk Veteran cohorts, continuity in vendor services is essential to ensure sample and data integrity, prevent delay of discovery, and avoid duplication of costs.

Therefore, award to this contractor represents the only path to maintain uninterrupted, high-quality proteogenomic services in support of C-DACS mission-critical objectives.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

An intent to sole source was posted on 28 July 2025 and closed 6 August 2025 with no response from industry.

Through market research and continued education of the industry through conferences, vendor interactions, and networking, and continued refinement of the Government�s requirements and needs, no other vendors have shown or have the ability to deliver the services required at scale. Academic core facilities lack long-read and proteomics throughput guarantees, while other vendors offered only discrete assay types or do not offer the full services required to meet all needs of the contract.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The previous contract, 36C24E20D0028 was determined fair and reasonable at time of award and the pricing for this requirement is expected to have the same outcome. The Contracting Officer will determine fair and reasonable pricing prior to award and negotiation will occur as required.