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FBO DAILY ISSUE OF AUGUST 28, 2009 FBO #2834
SOLICITATION NOTICE

B -- Study of the relationship between urinary F2-isoprostanes and gastric cancer risk

Notice Date
8/26/2009
 
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-90169-KM
 
Archive Date
9/25/2009
 
Point of Contact
Karri L. Mares, Phone: 3014357774, Caren N Rasmussen, Phone: (301) 402-4509
 
E-Mail Address
maresk@mail.nih.gov, cr214i@nih.gov
(maresk@mail.nih.gov, cr214i@nih.gov)
 
Small Business Set-Aside
N/A
 
Description
The National Cancer Institute (NCI) plans to enter into a sole source procurement for the study of the relationship between urinary F2-isoprostanes and gastric cancer risk from Vanderbilt University Medical Center; 526 Robinson Research Building; 23 rd Avenue South at Pierce Avenue; Nashville, TN 37232-6602. The supplies and 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 $13.5 million. The period of performance shall be for twelve (12) months from date of award. Elevated generation of reactive oxygen species or free radicals results in oxidative stress. Oxidative stress contributes to carcinogenesis potentially through direct DNA damage, lipid peroxidation, and protein modification. Oxidative stress, as a result of H. pylori infection and other sources, is a well hypothesized risk factor for gastric cancer. F2-isoprostanes are secondary end products of lipid peroxidation of arachidonic acid, and have been utilized as clinical markers of chronic inflammatory diseases. Recently, isoprostanes have been classified as a reliable biomarker of lipid peroxidation and the quantification of plasma or urinary F2-isoprostanes as the most accurate method of assessing in vivo oxidative stress status. The purpose of this procurement is to quantify the levels of urinary F2 isoprostane (15-F2-Isop) and its primary metabolite (15-F2-IsopM) using a GC/MS assay in a nested case-control study of 199 gastric cancer cases, 398 controls, and an additional 65 blinded quality control samples; 662 samples assay F2-isoprostanes, 662 samples assay F2-isoprostane Metabolite. In this study, NCI proposes to measure urinary isoprostanes by GC/MS in gastric cancer cases and controls from a nested case-control study. Cases and controls will be drawn from the Shanghai Women’s Health Study (SWHS). The purpose of this study is to investigate whether urinary isoprostane levels are associated with gastric cancer risk. In order to allow direct comparison of data from another study conducted within the SWHS, it is necessary for urinary isoprostanes by GC/MS to be performed in the same laboratory. Vanderbilt University, has created and further refined an operating assay that is capable of measuring levels of isoprostanes and isoprostane metabolites in biological fluids, including urine. There has been an attempt to develop other techniques to measure isoprostanes using ELISA assays as they would require less time, but thus far, these other methods have not demonstrated very high sensitivity or specificity and are not a suitable replacement for the GC/MS method that Vanderbilt University’s laboratory performs. The requested scope of the work can only be reasonably achieved with this novel assay, as alternative methods like ELISAs would not provide isoprostane levels that were accurate. Vanderbilt University has a leading molecular laboratory which has demonstrated both the expertise and resources for conducting isoprostane measurements in large epidemiologic studies. This laboratory has conducted analysis of isoprostane levels in relation to breast cancer risk in this same study population for another primary investigator of the Shanghai Women’s Health Study. To simplify the control of laboratory operations and guarantee standardized quality control procedures among studies from this study population, it is essential to conduct the isoprostane assays at the same lab. For these reasons, Vanderbilt University is the only known vendor to the NCI that can perform the required tasks. This is not a solicitation for competitive quotations. However, if any interested party believes it can perform the requirement as detailed they may submit a statement of capabilities. All information furnished shall be in writing and must contain sufficient details to allow the NCI to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement must be received in the contracting office on or before 11:00 am ET, on September 10, 2009. All questions must be in writing and must be emailed to Karri Mares maresk@mail.nih.gov or faxed to (301) 402-4513. 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 from the NCI, contractors must be registered in the Online Representations and Certifications Applications (ORCA). Please refer to http://orca.bpn.gov In addition; contractors must be registered in the Central Contractor Registration (CCR) www.ccr.gov. No collect calls will be accepted. Please reference NCI-90169-KM on all correspondence.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/NCI-90169-KM/listing.html)
 
Record
SN01927396-W 20090828/090827000736-55abb038f3df67b780a757813c739b66 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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