VHAPG Part 806.3 OFOC Page 1 of 8 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C24E-26-AP-0316

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C24E-26-AP-0316

1. Contracting Activity:

Department of Veterans Affairs Regional Procurement Office (RPO) East 1010 Delafield Road Pittsburgh, PA 15240

Requesting Activity:

Department of Veterans Affairs VA Palo Alto Health Care System (VAPAHCS) Precision Health Service (151 MVP/ERIC) Million Veteran Program Co-Chair Office 3801 Miranda Ave Palo Alto, CA 94304

2. Nature and/or Description of the Action Being Approved:

This action is for a new requirement for the Department of Veterans Affairs, VISN 21, VA Palo Alto Health Care System, Precision Health Service to obtain services for metabolomics analysis to measure at least 1000 metabolites (small molecules) within each blood sample provided by the VA Research Team. The estimated number of stored blood samples to be tested per contract year is 10,000 to 20,000. This requirement will be a Commercial, Firm Fixed Price, Indefinite Delivery, Indefinite Quantity (IDIQ) contract using RFO 12.102-1 for a period of performance of five years.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The Million Veteran Program requires metabolomics analyses services to measure >1000 metabolites from stored blood samples over the contract period. The resultant data will be used to build an analysis pipeline to correlate with disease traits. In addition, this data will be combined with other molecular and clinical data associated with Veteran patient samples to add more insight into disease progression and to aid precision medicine (disease management). Assays will offer sensitivity similar to industry standard assays as well as produce comparable data (correlation plots to demonstrate) for as many biomarkers available with detection limits sufficient to detect human physiological ranges – healthy and diseased.

The number of samples to be processed is estimated to be between 10,000-20,000 samples over the course of the contract per year. The value of this requirement is for a ceiling of as shown below.

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Acquisition ID#: 36C24E-26-AP-0316 with precision comparable to targeted MS approaches. Directly relevant for MVP, metabolite coverage showed marked differences across platforms with Metabolon reporting over 950 quantified, structurally elucidated metabolites, far more than the nearest competitor. Metabolon data also consistently showed greater coverage for Post-traumatic stress disorder (PTSD)- and Parkinson’s disease-associated metabolites, the main subjects of the study (other vendors evaluated had at most ~70% of the coverage in these pathways).

Collectively, the data indicates that Metabolon uniquely combines high reproducibility with the broadest disease-relevant coverage. Coupled with over 25 years of historical data supporting these findings and demonstrated success with over 100,000 MVP samples, these results strongly support the principle of platform continuity for longitudinal analysis. One of MVP’s goals is to make measurements of multiple samples from individual participants over time to monitor their disease course. This research requires consistency of the metabolomics platform to ensure that the results are comparable. Switching providers would pose a serious risk to the integrity of the dataset, potentially compromising compatibility with previously measured samples and significantly diminishing the overall scientific value of the work. To date, 100,000 samples have already been processed at a cost of $15,000,000, representing a substantial taxpayer investment. Re-running these samples to restore consistency would not only delay critical research outcomes but also require the government to commit significant additional funding to duplicate work that has already been completed.

The distribution of clinical samples and associated data are restricted and required to comply with the BIOSECURE Act (enacted December 2025) and new US Department of Justice rules on transfers of bulk sensitive personal and human ’omic data to “countries of concern.”

Due to the tightened scrutiny around sending clinical samples and associated data to some foreign countries, the samples must be processed in the Continental United States. The proposed vendor has existing laboratory facilities in the Continental United States for large-scale measurements in tens of thousands per-year and has demonstrated the ability to measure a broad array of metabolites (>1000) in human blood at scale to meet the required number of samples during the contract year. Some alternative vendors identified have partner labs in foreign countries including China. This operational model could result in MVP samples being processed in China, raising data security and compliance concerns.

The goal of the research, subject to this requirement, is to discover new biological processes to add insight into Veteran health. In support of this goal and related to this requirement, an internal chemical reference library of metabolites assures data accuracy and consistency over a large number of samples proposed. Additionally, a wider reference library enhances research allowing trends to be found in specific health conditions. An internal chemical reference library is required for this work because it allows the researchers to have a wider reference library that has been validated using the vendor’s own platform. This validation is critical to research results as it eliminates variables that might otherwise be present when using outside information. Other vendors mainly use publicly available databases that may not reflect their own equipment and therefore lack the validation process and potentially introducing unwanted variables that might otherwise have been avoided leading to poor or invalid research results. The proposed vendor has an extensive chemical reference library (>5400) metabolites that have been validated to cover the major relevant and wide range of

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Acquisition ID#: 36C24E-26-AP-0316 biological processes relevant to human health and disease representing the major relevant metabolic pathways for human health and disease.

As the proposed vendor’s reference library expands, there is evidence that they can recover further biomarker assays by mapping back to original readings from existing MVP datasets, thereby increasing the longitudinal scientific value of the data investment without requiring re-analysis and additional costs. Given that only a single blood sample is collected per participant, preserving that sample is critical. Repeated testing is not a viable option as additional consents and sample collection would need to be coordinated. The reference library capability is therefore essential, and important to the research as it enables significant insight to be extracted from each sample without depletion or remeasurement.

As previously mentioned, quality and consistency are critical factors in viable research. The proposed vendor has successfully measured metabolites in over 2,000,000 human samples over 25 years, including >100,000 samples for MVP to date. This is particularly important when comparing the results between samples measured at different times. This is important to the research because it demonstrates the quality and consistency of data across the scale of samples represented in MVP and supports the longitudinal analysis mentioned above.

The proposed vendor can process a minimum of 10,000 samples per year. This is base value the Government expects to order in one year and therefore it is a critical requirement. No other vendor surveyed has displayed the capability of reaching this processing threshold at this time nor has plans to adjust operations to achieve this threshold in the near future.

Peer-reviewed scientific publications are metric of data quality and demonstrate applicability of data to health outcome. A search of PubMed indicates over 1000 peer-review publications using Metabolon’s platform proposed for MVP. In the past 3 years, Metabolon data has been cited in more than 350 publications, which is 10 times more than the next metabolomics provider found on PubMed. These publications include those designed to identify individuals at high-risk on a wide range of medical entities (i.e., disease agnostic). Given the high degree of review standards required for publication, these results attest to the reproducible quality of their platform. In some of these publications, metabolite data has been combined with other clinical and molecular data to further derive insight into human biology. No other vendor offers comparable experience with published human EDTA plasma data, making Metabolon uniquely positioned to accelerate the government’s efforts to understand disease progression and advance precision medicine.

No other vendor has all the qualifications outlined above. Use of Metabolon preserves continuity, allowing data compatibility with prior metabolite measurements, enables consistent longitudinal analyses, and allows expansion to newly validated metabolites to be applied across the full dataset, including historical samples. Moreover, scientific and technical support is established, responsive and experienced with MVP requirements. This vendor is the is the only scientifically defensible provider for continued MVP metabolomics because they generated the existing MVP dataset (>60,000 Global Discovery samples and >30,000 Complex Lipid samples), and the program’s value depends on maintaining direct comparability across longitudinal timepoints to detect true biological changes. A change in

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Acquisition ID#: 36C24E-26-AP-0316 vendors and eliminating any one factor described above would result in newly derived data and producing a second dataset that would not be comparable to results already generated and reduce the statistical value of the entire effort and compromise the discovery power of the research. This would result in duplication of work and potentially losing the $15,000,000.00 investment already spent on this research.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as possible (including whether a notice was or will be publicized as required by RFO Part 5 and, if not, which exception under RFO Part 5 applies):

A notice of intent to sole source was posted to SAM on February 25, 2026 and ended on March 11, 2026 with two responses received. These responses are discussed in paragraph 8 below.

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

The previous contract was determined to be fair and reasonable at time of award, and it is anticipated that the cost to the Government will be fair and reasonable. Once the proposal is received, the proposal prices will be subject to price analysis and negotiations may be conducted if the Contracting Officer determines negotiations necessary.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market research was conducted between December 1, 2025, through March 2026 and included reviewing the acquisition history, the appropriate Veteran Small Business databases, System for Award Management (SAM) and the sources found in the Veterans Health Administration (VHA) Procurement Hierarchy chart per Federal Acquisition Regulation (FAR) and Veterans Affairs Acquisition Regulation (VAAR). More specifically, published journal articles of relevant metabolomic services were reviewed and conversations with industry and at conferences were conducted. A total of eight vendors were identified with seven having limitations on conducting business. Results are discussed below.

a) Arome Science (arome-science.com): Small business (<25 employees) based in the US. Offers both targeted and untargeted capabilities with an emphasis on method development and customization for novel research applications. Small service provider.

Current lab cannot process an additional 10,000 samples/year nor do they have immediate plans to do so. Results would not be directly comparable to measurements performed previously.

b) Biocrates Life Sciences (biocrates.com): Small business (<200 employees) based in Austria that was recently acquired by Bruker Corporation. Known in the market for producing standardized, ready-to-use kits and software that enable laboratories to perform high-throughput metabolic profiling. It also performs fee-for-service metabolic profiling as a CRO provider. Laboratory services are performed in laboratories in Austria.

Results would not be directly comparable to measurements performed previously.

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Acquisition ID#: 36C24E-26-AP-0316

c) MRM Proteomics (mrmproteomics.com): Small business (<100 employees) based in Canada. Broad and comprehensive proteomics platform with high sensitivity and broad dynamic range. Large catalog of readily available assays that can be ordered in panels based on type of metabolite. Use of EDTA plasma acceptable. Commercial entity based in Canada that can process 10,000 samples in contract year. Laboratory services are performed in laboratories in Canada. Results would not be directly comparable to measurements performed previously.

d) Metabolon (metabolon.com): Small business (<250 employees) based in US.

Comprehensive proteomics mass spectrometry platform with high sensitivity and broad dynamic range. Large catalog of readily available assays that can be ordered in panels based on type of metabolite. Use of EDTA plasma acceptable. CLIA certified commercial entity based in North Carolina USA that can process at least 20,000 samples in contract year.

e) Nightingale Health (nightingalehealth.com): Finnish company with US-based offices and processing facilities (<125 employees). Broad proteomics platform based on Nuclear Magnetic resonance that concentrates on clinically actionable metabolites with particular strength in lipid measurements. Use of EDTA plasma acceptable. Commercial facility in Pittsburgh that is CLIA certified and can process at least 10,000 samples in contract year. Due to different instrument platform compared to instrument used in current contract, results would not be directly comparable to prior measurements performed by Metabolon. Results would not be directly comparable to measurements performed previously.

f) Panome Bio (panomebio.com): Small business (<50 employees) based in US.

Contract research organization (CRO) offering multiple a discovery services including metabolomics and lipidomics, with untargeted and targeted panel services. Use of EDTA plasma acceptable. Current lab is not capable of processing an additional 10,000 samples/year nor do they have immediate plans to do so. Results would not be directly comparable to measurements performed previously.

g) Stanford University Mass Spec Core (https://mass-spec.stanford.edu):

Academic core facility based in the US (Stanford University). Mass spec-based service with limited number metabolites—generally develop assays at user requests instead of offering a full menu. Use of EDTA plasma acceptable. Cannot scale to 10,000 samples per year. Results would not be directly comparable to measurements performed previously.

h) NIH West Coast Metabolomics Center (https://metabolomics.ucdavis.edu):

NIH-sponsored core facility based in a US academic center (UC Davis). NIH sponsored center that has panels of assays available. Nonprofit/academic pricing. Use of EDTA plasma acceptable. Current lab is not capable of processing an additional 10,000 samples/year nor do they have immediate plans to do so. Results would not be directly comparable to measurements performed previously.