Q301--Research Lab Services - Specialized Biomarker Lab for TRACTS

STATEMENT OF WORK Contract Title: LIMBIC and TRACTs Biomarker Generation and Harmonization Background: The PRECEDE Laboratory at Johns Hopkins University will analyze proteins, mRNA, and other fluid biomarkers needed for LIMBIC and TRACTs consortium research. These analyses will be performed using Olink and Quanterix platforms, which are uniquely available in this laboratory. Resulting biomarker data will be harmonized using established analytical pipelines to allow cross-cohort comparison. Scope: . The samples are currently located at John Hopkins University as they were the site for the LIMBIC Biomarker Core and the basis for the samples being utilized for this project. Laboratory infrastructure including Olink, Quanterix, and Illumina sequencing will be used to generate proteomic and genetic data. Consumables and personnel support required for these analyses are to be included in the price and not separately billed. Services include execution of assays, data harmonization, and delivery of resulting datasets. Consumables will be shipped to the JHU laboratory. All assays and harmonization activities will occur within the PRECEDE Laboratory. Functions to be Performed Biomarker assay execution: Perform high‑throughput proteomic and fluid biomarker assays using Olink Explorer (5,400 proteins per kit) and Quanterix (Simoa) platforms on consortium samples. Sequencing support: Conduct Illumina‑based sequencing associated with biomarker panels and data verification workflows. Data harmonization: Apply established analytical pipelines to normalize, QC, and harmonize resulting datasets to enable cross‑cohort comparability for LIMBIC and TRACTs research. Logistics & sample handling: Receive consumables; manage sample intake, chain‑of‑custody, and lab processing through the PRECEDE Laboratory; deliver final datasets to the Government. 2) Services or Performance Required Scope & volume: Analyze up to 3,000 samples (initial minimum 1,250 samples on Olink Explorer) contingent on funding; provide end‑to‑end assay execution, QC, and harmonization. Outcomes: Delivery of validated, harmonized biomarker datasets suitable for cross‑cohort analyses, consistent with consortium standards. Timely completion of assay runs and sequencing per task order schedules. Essential Physical Characteristics Co‑located platforms: Access to and operation of both Olink and Quanterix platforms within the same laboratory are essential to maintain standardized protocols and ensure analytical comparability across cohorts; harmonization requires all assays to be run in one lab. Specific consumables & capacity: Availability of Olink Explorer kits (5,400 proteins scope), Illumina sequencing kits, and associated consumables; laboratory capacity to process 1,250+ samples in year one and scale up to 3,000 samples. Validated pipelines & QC: Established data harmonization pipelines, platform‑specific calibration/QA procedures, and secure data delivery capabilities are required to meet consortium scientific integrity standards Additional Information/Requirements:. Johns Hopkins University PRECEDE Laboratory is the only laboratory equipped with both Olink and Quanterix platforms required for the specified biomarker assays. No other vendor provides these combined capabilities. Analyses must be performed in the same lab to maintain harmonized protocols and ensure dataset comparability for reliability of research results.The vendor is the original developer of the harmonization analytical pipelines, offering proprietary methodologies that cannot be replicated without access to their internal infrastructure and expertise. Contract Type: Firm Fixed price Period of Performance: The period of performance will be based off the time of award for one year. A minimum of 1,250 samples to be processed on the Olink Explorer (5,400 protein) platform. The required kits and sequencing runs for this workload must be completed within the performance year. Place of Performance: Security Requirements: The C&A requirements do not apply, and a Security Accreditation Package is not required. VA RECORDS POLICY: All records (administrative and/or health specific) created during the period of the contract belong to Salt Lake City VAMC. Said records must always be handled in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300 Records and Information Management and its Handbook 6300.1 Records Management Procedures, VHA Records Control Schedule 10-1, and VA Handbook 6500.1 regarding Electronic Media Sanitization. Said records must also be returned to Salt Lake City VAMC at the end of the contract and/or destroyed in accordance with the VHA Record Control Schedule (RCS)10-1. For questions, please contact the Salt Lake City VAMC Records Officer. RECORDS MANAGEMENT STATEMENT Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chapters 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. In accordance with 36 CFR 1222.32, Contractor shall maintain all…