SOLICITATION NOTICE
Q -- Pilot Study of Epigenetic Variation and Prostate Cancer Risk
- Notice Date
- 7/10/2013
- 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
- N02CP32513-59
- Archive Date
- 8/9/2013
- Point of Contact
- Afua Serwah- Asibey, Phone: 240-276-6991
- E-Mail Address
-
serwahasibeya@mail.nih.gov
(serwahasibeya@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive RM 1E142, Rockville, MD 20892. Description The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), plans to procure on a sole source basis with Epigendx, Inc., 96 South Street, Hopkinton, MA 01748, to conduct 10 pyrosequencing assays to quantify DNA methylation levels at CG dinucleotides (CpG sites) in the chromosome 8q24 region for a total of 736 bisulfite-treated genomic DNA samples. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). The North American Industry Classification System code is 541380 and the business size standard is 500 employees. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. Period of Performance: Performance shall be for 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 is conducting a pilot study in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial to evaluate the association between DNA methylation levels at chromosome 8q24 in peripheral blood and prostate cancer risk. The proposed contractor will carry out the laboratory analysis to measure DNA methylation using pyrosequencing. Epigenetic variation may play a role in the etiology and pathogenesis of prostate cancer. Chromosome 8q24 has emerged as an important region for genetic susceptibility to cancer, particularly prostate cancer. Although substantial work has been done to study the role of single nucleotide polymorphisms (SNPs), little research has been conducted to explore the contribution of epigenetic variation in this region to cancer risk. This pilot study in the PLCO Cancer Screening Trial aims to evaluate the association between DNA methylation levels at chromosome 8q24 in peripheral blood and prostate cancer risk, which has not been previously studied. DNA methylation will be quantified at specific CpG sites across the 8q24 region using pyrosequencing, which is a high-throughput, quantitative method that is considered highly reproducible and sensitive to quantify differences in DNA methylation between individuals. The results of this study will provide important insights about the role of epigenetics at chromosome 8q24 in the etiology of prostate cancer. The Contractor shall perform the following tasks: the bisulfite-treated genomic DNA shall be PCR amplified within the chromosome 8q24 region. Sequencing shall be performed using pyrosequencing technology and the methylation levels analyzed. The Contractor shall provide one no template negative control sample, as well as three positive control samples [unmethylated (0%), hemimethylated (50%), and completely methylated (100%) respectively], that shall be included on each plate analyzed. The percent of methylation shall be expressed for each DNA locus as percent 5-methyl cytosine (5MeC) divided by the sum of methylated and unmethylated cytosines. All Pyrograms and sequencing traces used to determine methylation levels shall be provided to the NCI, 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 bisulfite treated DNA is available or additional genomic DNA can be provided by NCI. Milestone and/or phasing charts illustrate a logical sequence of proposed events. These shall be provided to the NCI Project Officer at the beginning of the study. Any remaining, unmodified DNA samples shall be shipped on dry ice and returned to the NCI biorepository in Frederick, Maryland upon request if not used for the molecular analyses described above. Samples shall be shipped on dry ice to the biorepository within three weeks of contract completion along with the electronic manifest of sample IDs and % methylation for each CpG site included in the assays. The proposed contractor, Epigendx, Inc., is able to provide services using the pyrosequencing method, which is a high-throughput, quantitative method that is considered highly reproducible and sensitive to quantify differences in DNA methylation between individuals. NCI previously conducted a pilot study with EpigenDx to develop and validate targeted pyrosequencing assays to quantify DNA methylation levels at specific CpG sites at chromosome 8q24. NCI plans to apply these assays in the current proposed study. If a different contractor is used, then NCI will need to re-develop and pilot the assays again to ensure that quality results can be obtained. In addition, the DNA samples for the current study are already residing at EpigenDx. If a different contractor is used, then NCI will need to aliquot additional DNA samples and ship them to the contractor, which will increase costs and use up more valuable samples. The samples used in this study are pre-diagnostic and an extremely precious resource for NCI. Thus, Epigendx, Inc. is the only known source to analyze the current samples to ensure quality results with the minimal use of valuable samples. This is not a solicitation for competitive quotations. However, if any interested party, especially small businesses, believes 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. The capability statement must be received at the NCI Office of Acquisitions on or before 11:00 AM EST on July 25, 2013. All responses and questions must be in writing and can be faxed (240)276-5401 or emailed to Afua Serwah- Asibey, Contract Specialist at afua.serwah-asibey@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 in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA), through sam.gov. No collect calls will be accepted. Please reference solicitation number N02CP32513-59 on all correspondence.
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