SOLICITATION NOTICE
B -- DNA Samples for Risk Factors for Bladder Cancer
- Notice Date
- 7/30/2008
- Notice Type
- Combined Synopsis/Solicitation
- 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, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-80147-MM
- Archive Date
- 8/29/2008
- Point of Contact
- Malinda L Holdcraft,, Phone: (301) 402-4509, Caren N Rasmussen,, Phone: (301) 402-4509
- E-Mail Address
-
holdcram@exchange.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 analysis of p53 mutations of approximately 200 DNA samples extracted from formalin fixed paraffin embedded tissue block samples for the Risk Factors for Bladder Cancer in the New England Study of Environmental Health with Transgenomics Discovery Services, 12325 Emmet Street; Omaha NE 68164. 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 541380 and the business size standard is $12M. The National Cancer Institute conducted a case-control study of bladder cancer among men and women in New England (02212). The purpose of the New England Study of Environment and Health (NESEH), is to investigate a number of environmental, occupational, and personal risk factors for bladder cancer. The NCI enrolled patients with bladder cancer who were identified in Maine, New Hampshire, and Vermont, between 2001 and 2004. Formalin fixed paraffin embedded (FFPE) tissue blocks were sectioned onto slides in preparation for microdissection and DNA extraction from each subject with an incident diagnosis of bladder cancer who provided consent for the collection of tissue and medical records. We are now planning to pilot test using DNA extracted from these cases for PCR-based molecular analyses from a subset of cases to determine if the quality and quantity of DNA is suitable for mutational spectrum and epigenetic assays. Contractor Requirements: 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. DNA shall be quantitated using quantitative PCR technology and the amount of non-degraded, PCR amplifiable DNA will be measured and reported. 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. For mutant samples, the specific exon, codon, and type of mutation (amino acid change, deletion, and insertion) shall be reported 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. All chromatograms and sequencing traces shall be included as electronic files with all reports. 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. Milestone and/or phasing charts illustrate a logical sequence of proposed events. These shall be provided at the beginning of the study. Period of performance shall be 12 months from date of award. Transgenomics is the only source known to the NCI that is currently the only company to provide this specific type of high-throughput, and sensitive sequencing services utilizing Surveyor endonuclease, an optimized derivative of Cel I endonuclease and the patented WAVE® system to separate fragments based upon size. Transgenomic, Inc. is uniquely qualified to carry out this effort because they are the only laboratory that analyzes promoter hypermethylation using bisulfite treated DNA and sequence analysis. Additionally, Transgenomic previously performed VHL mutational spectrum analysis and a pilot study of VHL promoter hypermethylation for the Central and Eastern European RCC study with high throughput that will allow for comparability of the results from these analyses to the previous study. 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 detail 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 by 1:00 pm EDT, on August 14, 2008. All questions must be in writing and must be emailed to Melissa Marino at marinome@mail.nih.gov 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-80147-MM on all correspondence.
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