SOLICITATION NOTICE
B -- A measurement of telomere length and its association with the risk of melanoma and dysplatic nevi in melanoma families with and without CDKN2A mutations
- Notice Date
- 9/1/2009
- 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-90227-AV
- Archive Date
- 9/26/2009
- Point of Contact
- Ashley L. Virts,
- E-Mail Address
-
virtsa@mail.nih.gov
(virtsa@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG) plans to procure on a sole source basis a measurement of telomere length and its association with the risk of melanoma and dysplatic nevi in melanoma families with and without CDKN2A mutations from Brigham and Woman's Hospital, Inc., 75 Francis Street, Boston, MA 02115-6110. The 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 is $13 M. The period of performance shall be twelve (12) months from date of award. Telomeres are ribonucleoprotein structures that protect the end of linear chromosomes from recognition as DNA double-stranded breaks and activation of a DNA damage response. In normal somatic cells, telomere shortening occurs with each cell division. When telomeres shorten to a critical length, the cells undergo senescence, apoptosis, or genomic ally unstable. Shorter telomere length (TL) has been linked to the increased risk of a variety of cancers. A recent prospective study found that shorter TL was associated with a decreased number of moles, a decreased risk of melanoma, but an increased risk of basal-cell carcinoma (BCC). Similarly, another study demonstrated that TL was positively correlated with total number of moles. Further, shorter TL was observed among p53 germline mutation carriers affected with Li-Fraumeni syndrome compared to unaffected carriers and wild-type controls. These findings suggested that TL might play an important role in familial melanoma/nevi syndrome, particularly among carriers with CDKN2A mutations. The CDKN2A gene is the major high-risk melanoma susceptibility gene identified to date. Although germline CDKJ\J2A mutations are associated with high risk of cutaneous malignant melanoma (CMM), the penetrance of this gene is incomplete and varies by age and geographic location. Further, phenotypic manifestations, such as age at diagnosis, presence/number of dysplastic nevi (DN), number of melanomas, and co-segregation of pancreatic cancer, vary significantly among mutation carriers even within a single family. These findings suggest that other factors may modify the effect of CDKN2A. The NCI has been conducting genetic linkage and association analyses (NHL OPA and iSelect) using data from the CMM-prone families collected from, and followed up for over 30 years to identify modifier genes for CDKN2A. In parallel to these conventional approaches, the NCI is also exploring copy number variations (CNVs) as an alternative approach to search for CMM susceptibility genes. The goal of this procurement is to determine TL in the melanoma families with and without CDKN2A mutations and to correlate TL with CMM, DN, mutation status, and genomic instability measured by CNVs. The objective of this procurement is to measure telomere length in genomic DNA extracted from blood samples of participants in CMM families with and without CDKN2A mutations. Specifically, TL in 600 DNA samples from 53 families with and without CDKN2A mutations, as well as an additional 100 blinded quality control samples, will be measured by quantitative-PCR (q-PCR). The laboratory of Dr. Immaculata DeVivo at Brigham and Women's Hospital is uniquely qualified to perform this work. Traditional methods for measuring TL including Southern blot and FISH require a large amount of DNA samples (5-10 ug) and laborious, which are not suitable for large scale molecular epidemiologic studies. The De Vivo Laboratory has validated and implemented the use of real time quantitative PCR to evaluate relative telomere length in large epidemiological studies which is critical since the assay is PCR-based, and high-throughput (384-well format on an ABI 7900HT platform). Large sets of samples are analyzed within a limited time span. In addition, it takes a small amount of DNA. The De Vivo laboratory has successfully completed projects for numerous researchers throughout the country including those in DCEG and published a number of papers on telomere length and risk of cancers such as prostate, breast, skin, bladder, and etc. The inter-assay coefficient of variation for their assay is extremely small, which is critical for the success to detect a small difference in TL in blood cells between cases and controls. The DNA samples used in this contract are precious since they were obtained from melanoma families that the NCI has collected and followed-up for years. The NCI may not have replacement for a subset of cases if they are deceased. Therefore, it is imperative that the laboratory performing IL assays for this project has a demonstrated capacity for achieving success with this material. In short, the De Vivo laboratory possesses expertise and resources for measuring TL in a consistent and timely manner, which is critical for the success of ongoing efforts to identify modifying factors for CMM and DN in melanoma families. This is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can meet this requirement. One (1) original and one (1) copy of the capability statement must be received in the contracting office by 11:00 a.m. ET on September 11, 2009. All questions must be in writing and can be faxed to 301-402-4513 or sent via email to Ashley Virts at virtsa@mail.nih.gov. It is the vendor's responsibility to ensure questions have been received. 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, contractor must have valid registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Application (ORCA). Please reference NCI-90227-AV on all correspondence.
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