Inactive

The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Metabolic Epidemiolog... The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Metabolic Epidemiology Branch (MEB) intends to procure, on a sole source basis, services to measure a wide spectrum of one-carbon metabolism biomarkers and the assessment of their associations with risks of esophageal squamous cell carcinoma (ESCC) and gastric cancer from BEVITAL AS, Jonas Lies Vei 87, Bergen, Vestland 5021, Norway. The response close date of the notice for this requirement is in accordance with FAR 5.203(b). This acquisition will be processed under FAR Part 12 – Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1(b)(1); and is exempt from the requirements of FAR Part 6. The North American Industry Classification System (NAICS) code is 541380 and the business size standard is $16.5 million. 1.0 BACKGROUND The Metabolic Epidemiology Branch (MEB) within the Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI), National Institutes of Health (NIH), Health and Human Services (HHS), conducts intramural research in areas related to nutrition, metabolism and cancer which are aimed at lowering human cancer risk. Focus areas of the MEB’s research include cancers of the upper gastrointestinal tract. Despite our long-term commitment to understanding the etiology of esophageal and gastric cancer, there remains substantial unexplained regional and cultural variation in their incidence. B vitamins and other molecules which play key roles in one-carbon metabolism (OCM) may contribute to the etiology of these cancers. However, previous studies have been limited, partly because high-throughput quantification of OCM biomarkers was not feasible until recently. This study seeks to determine the associations of plasma concentrations of OCM biomarkers, such as vitamins B2, B12, and total homocysteine, with esophageal squamous cell carcinoma (ESCC) and gastric cancer in nested case-control studies within the Golestan Cohort Study. MEB will measure biomarkers in 1,486 plasma samples from 343 ESCC cases and 343 matched controls, and 355 gastric cancer cases and 355 matched controls as well as 90 quality control (QC) samples. In the pilot study, participants of the Golestan Cohort Study in Iran had low plasma concentrations of certain OCM biomarkers because of their usual diet and uncommon food fortification and use of dietary supplements. A successful completion of this study will inform useful biomarkers to identify individuals at high risk of ESCC and gastric cancer in the area where the incidence of these cancers has been high. 1.1 OBJECTIVE The primary objective of this project is to measure a wide spectrum of biomarkers in the one-carbon metabolism and kynurenine pathways, including B vitamins to assess their associations with risks of ESCC and gastric cancers. Therefore, MEB requires services from a Contractor that offers multiple platforms for a set of biomarkers. The Contractor shall measure 33 biomarkers in four platforms by gas chromatography tandem mass spectrometry (GC-MS/MS) (Bevital Platform B), liquid chromatography tandem mass spectrometry (LC-MS/MS) (Bevital Platform D & E), and micro biological assay (Bevital Platform F). 2.0 SCOPE The Contractor shall perform assays in four platforms to measure 33 biomarkers in 1,486 plasma samples from 343 ESCC cases and 343 matched controls, 355 gastric cancer cases and 355 matched controls as well as 90 QC samples. The Contractor shall provide MEB/DCEG data on measures as well as their in-house quality control data. 3.0 CONTRACT REQUIREMENTS/ AND PERSONNEL The Contractor shall perform the following tasks: 3.1 The NCI will provide 1,451 plasma sample straws (1,396 samples from cases and controls plus 55 samples to create the 90 pooled QC sample). The samples will be shipped from International Agency for Research on Cancer (IARC). 3.2 The Contractor shall create a pooled QC sample from 55 sample straws sent for this purpose, then aliquot a pooled QC sample into 90 FluidX tubes of 250 mL samples. 3.3 The Contractor shall pull required volumes (250 mL) from received 1,396 sample straws for cases and controls to create 1,396 aliquots in FluidX tubes for four assays/platforms. A total number of aliquots in FluidX tubes will be 1,486 (1,396 aliqots from cases and controls and 90 aliquots from the pooled QC sample created in 4.2). 3.4 The Contractor shall arrange 1,486 child aliquots in appropriate assay orders provided by the NCI. 3.5 The Contractor shall undertake four assays for the measurement of 33 biomarkers in 1,486 plasma samples. 3.6 The Contractor shall provide the quantities of 33 biomarkers from the Bevital platform B, D, E and F in 1,486 plasma samples from Golestan Cohort Study as well as their in-house QC samples and provide results in an accessible format such as .txt, .xlsx or .csv within 12 months of the date of the award. The measurements shall be provided to the NCI Technical Point of Contact (TPOC) and reviewed to ensure completion and acceptable coefficients of variation. 3.7 The Contractor shall return the remaining samples to the following address at IARC: INTERNATIONAL AGENCY FOR RESEARCH ON CANCER (IARC) 145 Avenue des Frères Lumière (8h00-12h00) 69008 Lyon, FRANCE 4.0 TYPE OF ORDER This is a Firm-Fixed-Price Purchase Order for non-severable services. The services specified in each contract line item (CLIN) have been determined to be non-severable services - a specific undertaking or entire job with a defined end product of value to the Government. 5.0 PERIOD OF PERFORMANCE The anticipated period of performance shall be for 12 months from date of award. 6.0 PLACE OF PERFORMANCE All services shall be performed at the Contractor’s facilities. 7.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE The Contractor shall provide a report of the methods used and the data generated from the testing in an accessible format such as .txt, .xlsx, or .csv to the NCI Technical Point of Contact (TPOC), TBD at award. This report shall be submitted electronically, immediately on completion of the work and no later than one year after the date of the award. If no comments or requests for revisions are provided within 14 business days, the deliverables shall be considered acceptable. If the TPOC requests revisions, the report shall be delivered to the TPOC within five (5) business days after receipt of the Government’s comments at no additional cost to the Government. TPOC: TBD at award Email: TBD at award Phone: TBD at award All deliverables shall be provided in accordance with the following deliverables schedule: Deliverable #1 (Task 4.5): Quantitative results of 33 biomarkers from the Bevital platform B, D, E and F in 1,486 plasma samples in .txt, .xlsx, or .csv format due 12 months from the date of award. 8.0 UNIQUE QUALIFICATIONS OF THE CONTRACTOR Bevital is a leader in micronutrient and biomarker assays and has extensive experience measuring one-carbon metabolism and kynurenine pathway biomarkers, as demonstrated by numerous peer-reviewed publications. DCEG has had successful collaborations with Bevital in DCEG-led cohorts and other studies, including a pilot study within the Golestan Cohort Study, which has shown excellent quality of their assays with excellent performance characteristics. In Fiscal Year 2020, Westat, under contract number HHSN261201900001C, subcontracted Bevital to conduct assays to measure vitamin B and numerous other metabolites in plasma from a fixed subset of Golestan Cohort Study subjects. The current requirement is a continuation of this line of NCI research and Contractor services in which Bevital will measure a wide spectrum of one-carbon metabolism biomarkers and assess their associations with risks of ESCC and gastric cancer. It is critical to use the same laboratory, equipment, sample handling approach, quality control approach, and data processing to ensure the scientific comparability of the new data with the previous data. Any deviation from the proposed acquisition strategy would result in the NCI being unable to compare the results within the Golestan Cohort Study and across other DCEG-led studies, as the findings would not be scientifically comparable. 9.0 RESPONSE INSTRUCTIONS This notice is not a request for competitive quotations. However, if any interested party, especially a small business, believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in enough detail to allow NCI to determine if the party can perform the requirement. All responses must be submitted via email to Adam Hernandez, Contracting Officer at adam.hernandez@nih.gov. Responses are due no later than 3:00 P.M. EST Wednesday, July 21, 2021 (07/21/2021). A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for determining whether to conduct a competitive procurement. To receive an award, Contractors must be registered and have valid certification in the System for Award Management (SAM) through SAM.gov, and have Representations and Certifications filled out. Reference 75N91021Q00159 on all correspondence.