SOURCES SOUGHT
B -- Use of biomarkers for early detection of gastric cancer
- Notice Date
- 4/22/2020 2:03:05 PM
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- NIH NCI ROCKVILLE MD 20852 USA
- ZIP Code
- 20852
- Solicitation Number
- 75N91020R00026
- Response Due
- 4/30/2020 9:00:00 AM
- Archive Date
- 05/15/2020
- Point of Contact
- David Romley, Phone: 2402767822
- E-Mail Address
-
David.Romley@nih.gov
(David.Romley@nih.gov)
- Description
- SOURCES SOUGHT NOTICE: Use of biomarkers for early detection of gastric cancer Notice Number: 75N91020R00026 �Issued By: National Cancer Institute (NCI), Office of Acquisitions (OA) http://www.nci.nih.gov� or http://rcb.cancer.gov/rcb-internet/ Key Dates: Capability Statement Due Date: April 30, 2020 by 12:00PM EST This Small Business Sources Sought Notice (SBSS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI). The purpose of this Sources Sought Notice is to identify qualified Small Business concerns including 8(a), HUBZone or Service-Disabled Veteran-owned businesses that are interested in and capable of performing the work described herein. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned North American Industry Classification System (NAICS) code 541990 with a size standard of . As a result of this Sources Sought Notice, the NCI may issue a Request for Quotation (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME.� However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this Sources Sought Notice or the NCI�s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. 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 life style 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. 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 The lab kits will be used by to measure serum Pepsinogen I and II using a latex Agglutination reaction.� Pepsinogens are an abundant protein digestive enzyme secreted by the gastric chief cells as a proenzyme and then converted by gastric acid in the gastric lumen to the active enzyme pepsin.� Kits based on the Latex Agglutination reaction have been shown to be sufficiently sensitive and specific to support the aims of the current study. �The kits shall be based on methods consistent with previous NCI studies including cohort studies of gastric cancer risk conducted using the Nutrition Intervention Trial Cohort and the Alpha-Tocopherol Beta-Carotene Cancer Prevention Study Cohort.� Work using these cohorts and others has been published in multiple papers over the last 15 years and the measurements must be consistent with the previously published data to allow us to draw generalized inferences about the utility of these measurements in gastric cancer risk stratification.� The kits shall use anti-Pepsinogen 1 and anti-Pepsinogen II antibodies (respectively) that are proven not to cross-react with each other or other antigens that may be present in human serum.� The kits shall also be suitable for use with previously frozen serum that has been stored at ultra-low temperatures. �The quantity of kits shall be sufficient for 1700 assays (8 pepsinogen I kits, 8 pepsinogen II kits, 3 pepsinogen I standards, 3 pepsinogen II standards, 2 pepsinogen low controls and 2 pepsinogen high controls, totaling 26 packages).� This assay number is required to measure a previously selected subset of subjects that developed gastric cancer and a comparison group that had not using incidence-density sampling at 4:1 and which have already been used for other studies of gastric cancer risk stratifying antigens. 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. The quality control assays shall meet the required coefficients of variation of 20% or below as calculated by NCI based on the results provided by the contractor. 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. The quality control assays shall meet the required coefficients of variation of 20% or below as calculated by NCI based on the results provided by the contractor. 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. How to Submit a Response: Page Limitations: Interested qualified small business organizations should submit a tailored capability statement for this requirement not to exceed 10 single sided pages including all attachments, resumes, charts, etc. (single spaced, 12-point font minimum) that clearly details the ability to perform the requirements of the notice described above.� All proprietary information should be marked as such.�� Responses should include a minimum of a one page resume of the individuals meeting the requirements, and up to two pages demonstrating experience over the past two years meeting the requirements of this notice.� Statements should also include an indication of current small business status; this indication should be clearly marked on the first page of your capability statement (preferable placed under the eligible small business concern�s name and address).� Responses will be reviewed only by NIH personnel and will be held in a confidential manner. Organizations shall demonstrate 1.) Technical Approach 2.) Personnel Requirements and Organizational Experience. � Due Date:� Capability statements are due no later than April 30, 2020 by 12:00PM EST Delivery Point: All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the unique specifications described herein.� All questions must be in writing and emailed to David.Romley@nih.gov.� A determination by the Government not to compete this 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.� In order to receive an award, contractors must have valid registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through sam.gov.� No collect calls will be accepted.�Please reference number 75N91020R00026 on all correspondence. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization�s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a RFQ may be published in Fed Biz Opps. However, responses to this notice will not be considered adequate responses to a solicitation(s). Point of Contact: Inquiries concerning this Notice may be direct to: David Romley at David.Romley@nih.gov. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/e063ee562d214021bb4a6748fe9cb5d9/view)
- Place of Performance
- Address: Riga, LVA
- Country: LVA
- Country: LVA
- Record
- SN05632626-F 20200424/200422230138 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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