Use of biomarkers for early detection of gastric cancer
General Information Short Title: Use of biomarkers for early detection of gastric cancer Document Type: Notice of Intent Solicitation Number: 75N91020R00026 Posted Date: 6/17/2020 Response Date: 6/23/... General Information Short Title: Use of biomarkers for early detection of gastric cancer Document Type: Notice of Intent Solicitation Number: 75N91020R00026 Posted Date: 6/17/2020 Response Date: 6/23/2020 Classification Code: B529 – Special Studies/ Analysis-Scientific Data NAICS Code: 541990 – All Other Professional, Scientific and Technical Services Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E232 Bethesda, MD 20892, UNITED STATES Description The U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), intends to procure services on a sole source basis from LabMedTech AS, Bi?ernieku 57A-9/10, Riga, Latvia. This procurement is being conducted using commercial item procedures pursuant to FAR Part 12 and FAR Part 13, specifically FAR Subpart13.106-1(b)(1)(i) allowing the Contracting Officer (CO) to solicit from one source. Background All across the world, stomach (gastric) cancer is the 2nd most common cancer in men and the 4th in women. There is a striking geographical variation in gastric cancer incidence and mortality, as well as the significant changes in rates over time and among migrants, suggest a strong role for environmental and lifestyle factors in its pathogenesis. Helicobacter pylori (H. Pylori) infection and cigarette smoking have been identified as risk factors associated with higher risk of gastric cancer while higher intake of fruits and vegetables and the use of refrigerators have shown an inverse association with gastric cancer risk. In spite of H. Pylori infection decline in many developing countries, the prevalence and burden of gastric cancer (GC), is still high in these areas. Most cases of gastric cancer are diagnosed at a late stage, and for this reason, it has a poor survival rate. The 5-year survival rate is around 20%, with the notable exceptions of 65% in Japan and 71.5% in South Korea, where population screening has led to the effective diagnosis of tumors at early stages. Serum pepsinogen I, pepsinogen II and TFF3 tests in addition to H. Pylori testing have been suggested as potential methods to triage suitable candidates for more invasive screening methods, but evidence for their clinical application is still mainly limited to Japanese patients. The Golestan Cohort Study (GCS) has recruited a total of 50,045 people ages 40-75 from January 2004 to June 2008 in a high-incidence area and has followed them up since then. The current study is to use the data and biospecimens for assessing the role of two biomarkers (serum pepsinogen I and II and TFF3) for early detection of gastric cancer in this Cohort. So far, a total number of 319 gastric cancer cases have been diagnosed among the cohort participants, after a median follow-up of 11 years. This provides enough power to test these biomarkers using the baseline biosamples from cohort participants. OBJECTIVE The Division of Cancer Epidemiology and Genetics (DCEG) is planning to investigate the role of serum pepsinogen I, pepsinogen II and TFF3 in predicting the risk of gastric cancer development through a nested case-control design using data and biological samples collected in the Golestan Cohort Study. For this purpose, DCEG will use the services of LabMedTech to perform these assays in the plasma samples from the Golestan Cohort Study. These samples have already been shipped to the lab in Latvia from their original storage in WHO International Agency for Research on Cancer (IARC) repository in Lyon, through a previous contract with NCI. The assays have been validated and perfected by Dr Marcis Leja, and this lab is the world leading reference lab in performing these tests. DCEG has previously worked with this lab on validating these assays in plasma samples and expects reliable data from them. SCOPE This study includes 319 gastric cancer cases diagnosed during the cohort follow-up, and a 4 to 1 incidence-density matched set of controls (n=1276) stratified by major confounders, and 105 duplicate samples for quality control (a total of 1700 samples). LabMedTech will provide the necessary kits, and measure serum pepsinogen I and II and TFF3 in the plasma samples from these individuals and conduct H. pylori culture. The information obtained under this procurement will be used to determine the relationship between the concentrations of these biomarkers and the risk of gastric cancer development. CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS The Contractor shall perform the following tasks: Obtain pepsinogen I and II laboratory kits, in addition to the necessary standards, and high and low controls Perform serum pepsinogen I and II assays on all case and control and quality control samples selected by NCI (a total of 1700 assays). Perform serum TFF3 assay on all case and control and quality control samples selected by NCI and conduct H. pylori culture (a total of 1700 assays). Communicate to the NCI Contracting Officer’s Representative (COR) immediately via email or phone call if any unusual problems develop over the course of the project. Deliver all data to the NCI Contracting Officer’s Representative as a report and spreadsheets. REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE All reports required herein shall be submitted in electronic format. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible." Quarterly Progress Reports shall describe the general progress of the work, as well as any problems encountered. The Contractor shall deliver to NCI, no later than 12 months from the date of award, the data listed above, in spreadsheet form (e.g., tab-delimited text file or Excel file), which shall be sent electronically to NCI using secure transfer protocols. Any problems with data collection shall also be detailed in this dataset. The delivery schedule is outlined in the table below: DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS DUE DATE #1 (Task 4.1) Obtain pepsinogen I and II and TFF3 laboratory kits Written report and proof of shipment receipt in addition to detailed description of the obtained kits (which should meet the requirements described above). 30 days after award #2 (Task 4.2) serum pepsinogen I and II results Spreadsheet form (e.g., tab-delimited text file or Excel file) of 1700 assays in cases and 4:1 matched controls and quality control samples. 240 days after award #3 (Task 4.3) serum TFF3 results and H. Pylori culture Spreadsheet form (e.g., tab-delimited text file or Excel file) of 1700 assays in cases and 4:1 matched controls and quality control samples. 365 days after award NCI will ensure that all deliverables are executed as outlined. The Contractor shall work with NCI to confirm that the work is proceeding as planned through specific confirmation of each deliverable. The Contractor shall submit invoices as deliverables are completed. The NCI will have one month in which to review and accept the final data. If no comments or request for revisions are provided within two months, then the deliverables shall be considered acceptable. This acquisition will be processed under FAR Part 12 – Acquisition for Commercial items and will be made pursuant to the authority in FAR 13.106-1(b)(1) using simplified acquisition procedures for commercial items. The North American Industry Classification System code is 541990 and the business size standard is $15,000,000. Only one award will be made as a result of this solicitation. This will be awarded as a Severable Firm-Fixed Price type contract. It has been determined there are no opportunities to acquire green products or services for this procurement. DCEG will use the services of LabMedTech to perform the assays in the plasma samples from the Golestan Cohort Study. These samples have already been shipped to the lab in Latvia from their original storage in WHO International Agency for Research on Cancer (IARC) repository in Lyon, through a previous contract with NCI. The assays have been validated and perfected by Dr Marcis Leja, and this lab is the world leading reference lab in performing these tests. DCEG has previously worked with this lab on validating these assays in plasma samples and maintaining consistency with those assays is necessary to ensure reliable data from subsequent studies. The assays measuring pepsinogen I, II and TFF3 have been validated and perfected by LabMedTech, and this lab is the world leading reference lab in performing these tests. Dr Leja and his team have published numerous studies using this method in international collaborations and have tested the validity of the assays under different conditions. To the best of DCEG’s knowledge, there is no other lab with the expertise to conduct the serology tests required in this procurement. In addition, this lab possesses the capacity necessary to test these samples within the time period of this procurement. Finally, DCEG has used their services in the past, always with excellent reliability and accuracy. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 12:00 PM EST, on June 23, 2020. All responses and questions must be emailed to David Romley, Contract Specialist via electronic mail at david.romley@nih.gov. 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 the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management (SAM) through sam.gov. Reference: 75N91020R00026 on all correspondence.
Data sourced from SAM.gov.
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