SOLICITATION NOTICE
B -- Measurement of plasma NNAL from well-characterized lung cancer cases and population controls
- Notice Date
- 9/1/2009
- Notice Type
- Presolicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-90226-AV
- Archive Date
- 9/26/2009
- Point of Contact
- Ashley L. Virts,
- E-Mail Address
-
virtsa@mail.nih.gov
(virtsa@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG) plans to procure on a sole source basis measurement of plasma NNAL from well-characterized lung cancer cases and population controls from the University of Toronto, 1 King's College Circle, Room 4326, Department of Pharmacology, Toronto, Canada M5S 1A8. The services herein are being procured in accordance with the simplified acquisition procedures authorized by FAR Part 13. The North American Industry Classification System Code is 621511 and the business size standard is $12 M. The period of performance shall be eleven (11) months from date of award. Smoking is the proximate cause of lung cancer and genetic influences on the disposition of nicotine and downstream carcinogens have long been suspected of making an important contribution to susceptibility to tobacco's adverse health consequences. Previous work by NCI (Church et al., 2009) and others has established that patients with elevated NNAL are at increased risk of lung cancer. Genome wide association studies (GWAS) during the last year have unequivocally established that the region of chromosome 15q24-25.1 that contains three nicotinic receptor subunit genes is associated with lung cancer (Amos CI et al, 2008) and smoking (Thorgeirsson TE et al 2008, Saccone SF et al 2007; Caporaso N et al 2009). Mutations in CYP2A6, a gene which metabolizes both nicotine and carcinogens derived from nicotine, are related to both smoking phenotypes and the disposition of carcinogens such as those derived directly from nitrosamine carcinogens such as NNAL. The specific gene responsible, CYP2A6, cannot be studied in GWAS because the mutations involved are too rare in Caucasian populations and structural variation that alter gene function is poorly represented on the existing Illumina chip technologies. An alternate approach to characterizing CYP2A6 function is to assess the cotinine metabolic ratio (CMR) which can be determined from biomarker studies of cotinine and metabolites. Since both the nicotinic receptors and CYP2A6 are involved with mechanisms integral to the development of lung cancer and smoking, the NCI wants to investigate how they interact with each other to alter susceptibility to lung cancer. In the past year, GWAS studies have clearly established that a locus on chr15 that includes the nicotinic receptors is associated with both lung cancer and smoking. It is currently unknown how variation at this locus, a) influences lung cancer and smoking and how the later influences the former, b) how this genetic locus varies by characteristics of smoking, c) how the influence of this genetic locus varies by genetic variation at CYP2A6. This study will measure cotinine, 3-OH- cotinine, and nicotine in plasma samples from 350 lung cancer cases and 350 matched population controls from the EAGLE study to obtain the cotinine metabolic ratio (CMR) which assesses the activity of CYP2A6. The proposed contract will measure NNAL in the plasma to assess the production of this key carcinogen. The subjects enrolled will all have data on SNPs at the 15q24-25.1 locus. The scientific goals include determining the relationship of the CMR to NNAL and case-control status, and determining whether NNAL predicts lung cancer after accounting for smoking. The objective of this procurement is to measure plasma NNAL in 350 lung cancer patients and 350 population controls, all of whom are current smokers. Findings from this study will enhance an understanding of susceptibility to both lung cancer and the smoking trait by refining an understanding of how 2 genetic loci known to be involved in smoking and lung cancer susceptibility interact with each other and production of a key carcinogen. Specifically, the contractor shall: 1) perform an assay of NNAL (4-(Methylnitrosamino)-1-(3-Pyridyl)-1-Butanol, CAS= 76014-81-8) in plasma on a total of 700 samples obtained from current smokers; 2) include appropriate quality control measures; 3) one ml vial of coded plasma derived from an ACD (acid-citrate-dextrose) tube will be provided. An appropriate aliquot of plasma not required for the NNAL assay will be used for related nicotine metabolite assays. All material will be appropriately stored, aliquoted, labeled, and tracked. Excess material not required for assays or quality control will be shipped back to NCI; 4) include appropriate blinded duplicate samples to assess batch variation; 5) deliver raw and processed data to the NCI. The University of Toronto, Department of Pharmacology, has extensive experience in both pharmacokinetics and pharmacogenetics of nicotine and nitrosamine metabolism and CYP2A6, and can perform this assay with a reliable degree of precision and accuracy. This laboratory has assessed nicotine, nitrosamines and metabolites in numerous studies including non-smokers given nicotine, as well as in smokers and passive smokers. This ensures that the assay will have sufficient sensitivity to conduct the assay in the minimal amount of plasma that can be made available. The samples to be used for this contract derive from the Etiology and Genetics in Lung Cancer Study (EAGLE) and are an irreplaceable resource. Unlike the vast majority of pathological specimens that exist on lung cancer, these specimens are linked to an extensive database of epidemiological, clinical, genetic, laboratory and behavior data. There is however, limited specimen available on each subject and no more may ever be obtained since most of the study subjects are now deceased. The method used must be reliable, accurate, precise, and performed in a timely manner on hundreds of samples with minimal batch-to-batch variation. In addition, the sample laboratory will perform a closely related assay (cotinine and metabolites) on plasma obtained from the same vials. The assays require a single thaw with rapid sample preparation for a dual set of assays. It is essential that the same laboratory perform the assay in order to minimize sample handling and freeze-thaw cycles. Dr. Rachel F. Tyndale, Department of Pharmacology, University of Toronto, is the most experienced investigator in the world in conducting CYP2A6 assays and the only one with the expertise to evaluate CYP2A6, cotinine, nicotine, and NNAL in a highly accurate and economical (with regard to specimen) manner. Accordingly, the University of Toronto is uniquely qualified to perform work under this procurement. This is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can meet this requirement. One (1) original and one (1) copy of the capability statement must be received in the contracting office by 11:00 a.m. ET on September 11, 2009. All questions must be in writing and can be faxed to 301-402-4513 or sent via email to Ashley Virts at virtsa@mail.nih.gov. It is the vendor's responsibility to ensure questions have been received. 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, contractor must have valid registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Application (ORCA). Please reference NCI-90226-AV on all correspondence.
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