SOLICITATION NOTICE
Q -- Study to Measure Estrogens and Estrogen Metabolites in Concurrently Collected Serum and Urine Samples from Premenopausal and Postmenopausal Women
- Notice Date
- 8/3/2018
- Notice Type
- Presolicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CP82617-73
- Point of Contact
- Ronette P. Collins, Phone: 2402765745, Reyes Rodriguez, Phone: 240-276-5442
- E-Mail Address
-
ronette.collins@nih.gov, reyes.rodriguez@nih.gov
(ronette.collins@nih.gov, reyes.rodriguez@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E132, Bethesda, MD 20852, UNITED STATES. Description The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Epidemiology and Biostatistics Program (EBP) plans to procure on a sole source basis services to measure estrogens and estrogen metabolites in a single low-volume sample of serum or urine with a LC-MS/MS method from Eurofins Craft Technologies 4344 Frank Prince Church Road Wilson NC 278993. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1 (b)(1), using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System code is 541380 and the business size standard is $15 million. Only one award will be made as a result of this solicitation. This will be awarded as a severable firm fixed price type contract. Period of Performance shall be 12 months after date of award. It has been determined that there is no opportunity to acquire green products or services under this contract. The National Cancer Institute (NCI) has developed a stable isotope dilution liquid chromatography/tandem mass spectrometry (LC-MS/MS) assay for measuring concurrently 15 estrogens and estrogen metabolites in human serum with high sensitivity, validity, and reproducibility (Xu X et al, Anal Chem 2007 79:7813-21). NCI has also developed a comparable LC-MS/MS assay for measuring the same 15 estrogens and estrogen metabolites in urine (Xu X et al, Anal Chem 2005 77:6646-54). Both total (unconjugated+conjugated) and unconjugated concentrations are measured in serum, but only total concentrations are measured in urine since nearly all estrogens/estrogen metabolites in urine are conjugated. The specific estrogens and estrogen metabolites measured 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 these LC-MS/MS assays for estrogens/estrogen metabolites allowed for the first-time robust tests of these hypotheses about estrogen metabolism in population studies. NCI investigators and collaborators have now published five cohort-based epidemiologic studies of breast cancer that utilize either the serum or urine estrogen/estrogen metabolite assay. Even though the detailed results of the individual studies differ, each of these studies suggests that estrogen metabolism may indeed contribute to breast cancer risk. Specifically, increased 2-hydroxylation of parent estrogens is significantly associated with reduced risk, possibly by promoting excretion of parent estrogens and bioactive estradiol. However, little is known about the interrelationships of circulating and urinary parent estrogens and of circulating and urinary estrogen metabolism patterns. NCI proposes to explore these relationships using concurrently collected serum and urine samples. Results will clarify whether an individual's estrogen metabolism profile is similar in serum and urine and whether specific serum estrogen metabolism profiles are associated with enhanced excretion of parent estrogens and estradiol. Results will also help integrate and interpret the various cohort studies of estrogen metabolism and breast cancer that relied on either serum or urine samples. The NCI will measure by LC-MS/MS method estrogens and estrogen metabolites in serum and urine samples that were collected at the same time. Initially NCI planned to include a total of 125 postmenopausal women and 75 premenopausal women, at different phases of the menstrual cycle. None of the women will have taken exogenous hormones or been pregnant or lactating in the last 12 months. Participants will be from the Harvard Nurses cohorts (Caucasian), the Johns Hopkins Medical Institutions breast and ovarian cancer screening program (Caucasian and Black), and the Shanghai Physical Activity Study (Chinese). Both total (conjugated+unconjugated) and unconjugated concentrations of estrogens/estrogen metabolites will be measured in serum; only total concentrations will be measured in urine since unconjugated forms are rare in urine. NCI will investigate the interrelationships, in serum and urine, of total estrogen, individual estrogens and estrogen metabolites, and estrogen metabolic pathway groupings. Absolute concentrations, ratios, and percent of total estrogen will be explored. The influence of menopausal status, age, BMI, and race will be assessed. NCI anticipates that unusually accurate and precise data will facilitate disentangling these complex relationships. Recently NCI decided to expand the study by an additional 25 postmenopausal women and 55 premenopausal women. This will enable the NCI to calculate more precise estimates of the interrelationships among estrogens and estrogen metabolites in serum and urine, as well as calculate more precise estimates in racial subgroups. It will also enable to investigate whether the interrelationships vary by menstrual cycle phase in premenopausal women. To the NCI knowledge, Eurofins Craft Technologies is the only known laboratory that has developed an assay for the estrogens and estrogen metabolites in serum and urine with the following characteristics: 1) sensitivity adequate to detect at least 15 estrogens and estrogen metabolites in postmenopausal women; 2) high reproducibility (≤ 10% coefficients of variation, including all steps of 6e procedure, for estrone, estradiol, and most of the estrogen metabolites); 3) demonstrated accuracy, based on calibration of the estradiol measurements with the CDC Hormone Standardization Program; and 4) low volume requirements (≤ 0.3 mL for each assay). Approximately 40 samples can be assayed in a week. Therefore, the assay is rapid enough to be used with the multiple samples required by a large epidemiologic study. Additionally, NCI awarded a contract previously to Craft Technologies for the development and validation of a LC/MS/MS assay for measuring estrogens and estrogen metabolites in serum and urine samples. Contract Requirements: The Contractor shall: 1) Provide updated performance characteristics of the LC-MS/MS estrogen/estrogen metabolite assay in serum and urine, including accuracy, reproducibility, and sensitivity. 2) Measure unconjugated estrogens/estrogen metabolites and total (unconjugated+conjugated) estrogens/estrogen metabolites in 90 serum samples using an accurate, precise, sensitive LC-MS/MS method. 3) Measure total (unconjugated+conjugated) estrogens/estrogen metabolites in 90 urine samples using an accurate, precise, sensitive LC-MS/MS method. 4) Provide the results of the assays to the NCI Technical Point of Contact (TPC). Results shall be provided within one month of completion of the assays. Reporting Requirements and Deliverables: The Contractor shall provide: Estrogen/estrogen metabolite concentrations for each of the 90 serum and 90 urine samples within one month of completing the assays. Total and unconjugated concentrations shall be provided for the serum samples; total concentrations shall be provided for the urine samples. The report shall be submitted in a Microsoft-compatible electronic format to the technical point of contact (TPC). Provide a description of any problems that develop during the assay procedures. Provide a brief updated description of the LC-MS/MS estrogen/estrogen metabolite assay methods, in serum and urine, and the current performance characteristics, including accuracy, reproducibility, and sensitivity. No residual sera need to be returned to the NCI. This is not a solicitation for competitive quotations. However, if any interested parties, especially small businesses, believe they can meet the above requirement, they may submit a statement of capabilities. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. A copy of the capability statement must be received in the NCI Office of Acquisition on or before 4:00 PM EST on August 13, 2018. All questions must be in writing and can be faxed (240) 276-5401 or emailed to Ronette Collins, Contract Specialist at ronette.collins@nih.gov. A determination by the Government not to compete this proposed contract 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 on Sam.gov, www.sam.gov. No collect calls will be accepted. Please reference solicitation number N02CP82617-73 all correspondence.
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