SOLICITATION NOTICE
B -- HPV serologic testing from the HIM study for the study and Multiplex serology testing to Major Risk Factors for Gastric Cancer in Golestan Cohort Study
- Notice Date
- 8/14/2018
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 1050, Frederick, Maryland, 21702, United States
- ZIP Code
- 21702
- Solicitation Number
- N02CP82641-57
- Point of Contact
- Reyes Rodriguez, Phone: 240-276-5442
- E-Mail Address
-
reyes.rodriguez@nih.gov
(reyes.rodriguez@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Bethesda, MD 20892, UNITED STATES Description The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG) plans to procure on a sole source basis services to identify, pull, aliquot, ship and test samples as for two (2) studies as described below from DKFZ, German Cancer Research Center, 69120 Heidelberg, Germany. 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)(i) using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System Code is 541990 and the business size standard is $15.0 million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance shall be two (2) years from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. The National Cancer Institute, and the Division of Cancer Epidemiology and Genetics (DCEG) conducts the following studies: Study 1. Human papillomavirus (HPV) is the cause of cervical cancer, as well as subsets of cancers at other anatomic sites, including the oropharynx, vulva/vagina, penis, and anus. NCI reported that HPV16 E6 seropositivity was present in prediagnostic samples for 35 to 50% of oropharyngeal cancer cases, as well as some anogenital cancers. The increased risk of oropharyngeal cancer among HPV16 E6 seropositive participants was independent of time between blood collection and diagnosis and was observed more than 10 years before diagnosis. Further, this uniquely specific biomarker is consistently present in ~0.5% of controls from nested case-control studies. NCI's recent PLCO nested case-control study assessed the biomarker in 924 controls and 5 were positive. This represents the totality of the knowledge on the natural history of the biomarker in cancer-free men-the group at highest risk of HPV-driven OPC and thus the presumed population in which screening could potentially occur. NCI now aims to continue to expand its evaluation of HPV16 E6 serology in healthy individuals. This will be done in 2 phases. Study 2. Gastric cancer is the 2nd most common cancer in men and the 4th in women in developing countries. The 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. The Golestan Cohort Study (GCS) has recruited a total of 50,045 people aged 40-75 from January 2004 to June 2008 in a high-incidence area and has followed them up since then. So far, through January 2018, a total number of 319 GC cases have been diagnosed among the cohort participants, after a median follow-up of 10 years. NCI is going to use the available data and biospecimens from this study for the analysis of risk factors and correlates of gastric cancer. This will be done in 2 phases. OBJECTIVE The purpose of the procurement for both studies is as follows: Study 1. German Cancer Research Center (DKFZ) shall contract with Moffit directly to pull, aliquot (including blinded replicates), package and ship serum samples from the HIM study stored at the Moffitt Cancer Center to Heidelberg, Germany. This will be done in two phases; the first phase shall test a full series of samples; the second optional phase shall use results generated in phase 1 to sample and select for a second round of testing. German Cancer Research Center (DKFZ) shall perform HPV testing of these serology samples sent from Moffit from a subset of men in the HPV in Males (HIM) cohort study. This will also be done in 2 phases. Study 2. German Cancer Research Center (DKFZ) shall contract with World Health Organization (WHO) International Agency for Research on Cancer (IARC) directly to pull, aliquot (including blinded replicates), package and ship serum samples from the GCS study stored at the IARC Repository in Lyon, France, to Heidelberg, Germany. German Cancer Research Center (DKFZ) shall perform H. Pylori multiplex serology on all case and control and duplicate samples selected by NCI (a total of 1700 samples). This includes 42 H. pylori proteins which have been bacterially expressed and GST tagged. CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS Study 1. In phase 1, Contractor shall request Moffit to select, pull, aliquot and ship 4200 serum samples from participants in the HIM cohort to the German Cancer Research Center (DKFZ) for HPV serologic analysis using the ELISA assay. Optional Task - Phase 2. Contractor shall use the HPV serology results generated in phase 1 and other test results to identify, pull, aliquot and ship a second batch of 350 HIM serum samples to DKFZ for HPV serologic testing using both the ELISA and Luminex assays. In both phases, the Contractor is responsible for contracting with Moffitt Cancer Center to ship samples directly to DFKZ. Once HPV serology results are received from both rounds of serologic analyses, HIM study data from Moffitt Cancer Center shall be merged with HPV serology test results from DKFZ to create a master analytic file (including covariates such as, but not limited to, age, SES, geographic location, smoking history, sexual behavior, and others). This anonymized Masterfile shall be shared between NCI, DKFZ and Moffitt investigators. Study 2. In phase 1, Contractor shall request IARC to select, pull, aliquot and ship 1700 serum samples from participants in the GCS to the German Cancer Research Center (DKFZ) for H. Pylori multiplex serology. These samples include 319 gastric cancer cases diagnosed during the cohort follow-up, a 4 to 1 incidence-density matched set of controls (n=1276) stratified by major confounders, and 105 duplicate samples for quality control. In phase 2, DKFZ shall perform multiplex serology to measure H. Pylori antigens in the plasma from 1700 samples shipped to them, and deliver all results, and detailed data from the serology assays to NCI as a report and EXCEL spreadsheets. The information obtained under this procurement will be used to determine the relationship between different risk factors and the risk of gastric cancer development. PLACE OF PERFORMANCE All work shall be performed at the Contractor's facility. DKFZ is the only known lab that runs a Luminex-based serologic assay for the necessary HPV genotypes and proteins as well as Multiplex serology testing, which is a high-throughput method for detection of antibodies to up to 100 different antigens in large serological studies. The assays have been developed and perfected by DKFZ. To the best of NCI's knowledge, there is no other lab with the expertise to conduct the wide range of 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. Also, this is a continuation of previously studies conducted by DKFZ. Any alterations to the results will result on waste of Federal funding and time. Thus, NCI plans to make an award to DKFZ. 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 August 21, 2018. All responses and questions can be emailed to Reyes Rodriguez, Contracting Officer via electronic mail at reyes.rodriguez@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. 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: N02CP82641-57 on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF/N02CP82641-57/listing.html)
- Place of Performance
- Address: All work shall be performed at the Contractor's facility., United States
- Record
- SN05035364-W 20180816/180814230947-fbb88dc2714c92299cffbf90851fb235 (fbodaily.com)
- Source
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