SOLICITATION NOTICE
B -- Risk Factors for Bladder Cancer in The New England Study of Environmental Health
- Notice Date
- 8/28/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541380
— Testing 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, MD, 20852, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-NCI-70144-NV
- Response Due
- 9/11/2007
- Archive Date
- 9/26/2007
- Description
- In accordance with Simplified Acquisition procedures, the National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Occupational Epidemiologic Branch (OEB), plans to procure, on a sole source basis, for the analysis of the mutational spectrum of exons 5-8 of the p53 gene from the case-control study of bladder cancer among men and women ?New England Study of Environment and Health (NESEH)? from Transgenomic, Inc., 12325 Emmet Street, Omaha, NE 68164. The North American Industry Classification System Code is 541380 and the business size standard is $11M. The purpose of the study is to investigate a number of environmental, occupational, and personal risk factors for bladder cancer. OEB has collected formalin fixed paraffin embedded (FFPE) tissue blocks which were sectioned onto slides in preparation for microdissection and DNA extraction from each subject with an incident diagnosis of bladder cancer. OEEB is planning to pilot test molecular analyses using DNA from these cases to determine if the quality and quantity of DNA is suitable for mutational spectrum and epigenetic assays. Pathology tissue from cancer patients provides increasing opportunities for the study of biological questions relevant to tumor etiology and for detecting early markers of disease and progression. Pathology specimens provide a resource for examining DNA, proteins and RNA in tissue and can be used to compare tumors that are associated with different risk factors, thus strengthening associations that might be made between exposures and disease to strengthen causal inference and identify determinants of survival. Transgenomic will complete the following tasks: 1) DNA shall be isolated and quantitative PCR measurements analyzed using three 5-micron tissue sections on slides that were sectioned from formalin fixed paraffin embedded tissue blocks that have been microdissected and placed in 1.5ml tubes; 2) DNA shall be quantitated using quantitative PCR technology and the amount of non-degraded, PCR amplifiable DNA will be measured and reported; 3) Mutation screening of exons 5-8 of the p53 gene shall be screened using Surveyor endonuclease. Digests by capillary electrophoresis, double stranded sequencing, and sequence analysis shall be conducted and analyzed by the contractor; 4) For mutant samples, the specific exon, codon, and type of mutation (amino acid change, deletion, and insertion) shall be reported to the PO in an electronic format using MS Excel. Samples without mutations shall be reported as not having mutations. The reports shall be provided three months after receipt of samples; 5) All chromatograms and sequencing traces shall be included as electronic files with all reports; and 6) If samples fail to sequence, re-amplification at no additional charge to the government shall be completed at least two times if sufficient DNA is available or can be provided by the PO. Transgenomic, Inc. is the only contractor known to the NCI that is uniquely qualified to carry out this effort because they have developed a unique technological approach using a combination of Surveyor Endonuclease, an optimized derivative of Cel I endonuclease and the patented WAVE? system to separate fragments based upon size which make this method uniquely suitable for high-throughput analysis of large numbers of samples. The quality control and their technological approach are best for the mutation detection of large numbers of samples. The sensitivity and specificity of the technology used by Transgenomic will provide results that are more informative in a timely manner. This is not a request for competitive quotation. However, if any interested party believes it can perform the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other furnished information must be in writing and must contain material in sufficient detail to allow NCI Researcher to determine if the party can perform this requirement. Capability statements must be received in the contracting office by 1:00 PM EDT September 11, 2007. Faxed and emailed capability statements are NOT authorized. Questions must be submitted in writing to Deborah Moore, Contract Specialist, at dm170b@nih.gov or faxed to 301-402-4513. 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 Application (ORCA). Please cite reference number NCI-70144-NV on all correspondence.
- Record
- SN01387261-W 20070830/070828220424 (fbodaily.com)
- Source
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