Measurement of Heparin-Plasma Concentrations of Fifteen Estrogens

Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E136, Bethesda, MD 20892, UNITED STATES Description National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), plans to procure on a sole source basis services to Measure Heparin-Plasma Concentrations of Fifteen Estrogens and Estrogen Metabolites in a Nested Case-Control Study of Postmenopausal Breast Cancer in the Nurses' Health Study I Cohort from Craft Technologies Inc. 4344 Frank Price Church Road, Wilson, NC 27893. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541380 and the business size standard is $14.0 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 is twelve (12) months from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. The NCI has developed a stable isotope dilution liquid chromatography/tandem mass spectrometry (LC-MS/MS) assay for measuring concurrently all 15 estrogens and estrogen metabolites in human serum, in both unconjugated+conjugated and unconjugated only forms, with high sensitivity, validity, and reproducibility (Xu X et al, Anal Chem 2007 79:7813-21). The specific estrogens and estrogen metabolites include the parent estrogens (estrone and estradiol); metabolites in the 2-hydroxylation pathway (2-hydroxyestrone, 2-methoxyestrone, 2-hydroxyestradiol, 2-methoxyestradiol, and 2-hydroxyestrone-3-methyl ether); metabolites in the 4-hydroxylation pathway (4-hydroxyestrone, 4-methoxyestrone, and 4-methoxyestradiol); and metabolites in the 16-hydroxylation pathway (16a-hydroxyestrone, estriol, 17-epiestriol, 16-ketoestradiol, and 16-epiestriol). Laboratory and clinical studies have suggested that specific estrogen metabolism profiles and/or specific estrogen metabolites may play a role in breast cancer etiology. Development of the LC-MS/MS assay allowed for the first time robust tests of these hypotheses about estrogen metabolism in population studies. NCI investigators and collaborators have now published several important epidemiologic studies of breast cancer risk that utilize the serum estrogen/estrogen metabolite assay; these studies suggest that estrogen metabolism may indeed contribute to breast cancer risk. NCI now wants to replicate and extend these findings in another large, well-designed cohort with carefully stored prospectively collected Heparin Plasma blood samples and detailed information on breast cancer outcomes and risk factors. The NCI assay is currently available only for the use of serum samples not Heparin Plasma samples. The contractor shall 1). demonstrate laboratory capabilities to measure conjugated+unconjugated concentrations of 15 estrogens/estrogen metabolites, including reproducibility, accuracy, and sensitivity, using a run-in of 34 heparin-plasma samples from Nurses' Health Study I cohort and 2). assay conjugated+unconjugated concentrations of 15 estrogens/estrogen metabolites in 1150 heparin-plasma samples (sample volume=0.3 mL) from a nested case-control study of postmenopausal breast cancer in Nurses' Health Study I cohort. Results from each batch of analyses shall be transmitted to the COR within three working days of completion of the assays. Each assay batch must include samples with certified estradiol values from the Centers for Disease Control Hormone Standardization Program Craft Technologies is the only known source that has developed an assay for the 15 circulating estrogens and estrogen metabolites (in either conjugated+unconjugated or only in unconjugated form) using heparin-plasma samples. The Craft Technologies assay can provide results with 1) sensitivity adequate to measure all 15 estrogens and estrogen metabolites in postmenopausal women, 2) high reproducibility (? 10% coefficients of variation, including all steps of the procedure, for estrone, estradiol, and most of the estrogen metabolites), 3) demonstrated accuracy, based on calibration of the estradiol measurements with the Centers for Disease Control Hormone Standardization Program, and 4) low volume requirements (? 0.3 mL for each assay). 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 responses 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 11:00 AM EST, on September 12, 2013. All responses and questions must be in writing and faxed +1 (555) 000-0000 or emailed to Terry Galloway, Contracting Officer via electronic mail at contact@example.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 Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through sam.gov. Reference: NCI-130149-TG on all correspondence.