SOLICITATION NOTICE
B -- HPV in Lung Cancer Tumors
- Notice Date
- 8/12/2009
- 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-90157-MM
- Archive Date
- 9/11/2009
- Point of Contact
- Melissa P Marino, Phone: 301-402-4509, Caren N Rasmussen, Phone: (301) 402-4509
- E-Mail Address
-
marinome@mail.nih.gov, cr214i@nih.gov
(marinome@mail.nih.gov, cr214i@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG) Genetic Epidemiology Branch (GEB) plans to procure on a sole source basis with Ohio State University Medical Center, 690 Tzagournis Research Facility, 420 W. 12th Avenue, Columbus Ohio 43210 services regarding Human Papillomavirus in lung cancer tumors. The North American Industry Classification System Code is 621511 and the business size standard is $13.5M. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). Only one award will be made as a result of this notice. This will be awarded as a firm fixed price type contract. The period of performance is twelve months. Lung cancer is the leading cause of cancer death worldwide. The Genetic Epidemiology Branch (GEB) conducts intramural research in the areas of genetics (human and infectious) and cancer, as well as cancer and prevention. The GEB, Division of Cancer Epidemiology and Genetics (DCEG), NCI is currently examining the hypothesis that human papillomavirus (HPV) is involved in lung cancer. To estimate the prevalence of HPV infections in lung cancer cases from GEB's Environmental And Genetic Lung cancer Etiology (EAGLE) study, the branch requires services for measurement of HPV DNA in paraffin-embedded tissue. The purpose of this procurement is to test and obtain data on HPV prevalence in lung tumor fixed tissue specimens using sensitive and specific PCR. This data will aid the GEB in the execution of a case series study of lung cancer in EAGLE. Understanding if HPV plays a role in lung cancer could have public health implications. The contractor shall test 450 paraffin-embedded lung tumor tissues for HPV16 and 18 using PCR with type-specific primers for the E6 region and provide requested data (information on HPV DNA status (positive or negative), HPV type (HPV16 or 18), quality control data, and details on methods) The current acquisition is based on the need to generate new data consistent with our existing data using the most sensitive, accurate, and appropriate method available. The Ohio State University Comprehensive Cancer Center-James Cancer Hospital and Solove Research Institute is one of only 41 NCI-designated Comprehensive Cancer Centers in the United States and is ranked among the top 20 cancer hospitals in the nation. The Ohio State University has an aggressive and ongoing strategy to recruit the world's best and brightest cancer researchers and clinicians, which has recently included Dr. Maura Gillison. Dr. Gillison was the first to identify HPV infection as the cause of certain oral cancers and identified multiple sex partners as the most important risk factor for these cancers. Because of her experience, Ohio State University is now one of the world's leading institutions for the evaluation of HPV in the aerodigestive tract. Preliminary analysis and sample preparation has been conducted according to methods that optimize the measurement of HPV DNA in paraffin-embedded tissue. Dr. Gillison of Ohio State University adapted this methodology for use in non-cervical tissues such as the lung. To maintain consistency with the existing data that was generated from the EAGLE specimens, services are needed from Ohio State University to test the remaining samples. EAGLE specimens are extremely precious samples obtained from highly characterized and representative cases of lung cancer. Unlike the vast majority of pathological specimens that exist on lung cancer, these specimens are linked to an extensive database of epidemiological, clinical, genetic, laboratory and behavioral information. There are only a limited number of slides available from each patient. Also, most of the patients are now deceased, meaning no further material can ever be obtained. Therefore, the analytic technique used to prepare the material from the slides for the HPV assay must be precisely adapted to the exact assay to be performed. There can be no second opportunity since the assay techniques consume the material on the slide. If the assay fails or if quality control is inadequate, both the sample and test result will be lost. Since the HPV DNA purification method is critical for HPV detection, these specimens must be tested using the methods optimized specifically for them. Each step in the technical procedure must be performed with careful attention to the detail of the protocol. If the DNA on the slides is not extracted in a precise manner requiring the skill and experience of this team in performing these assays on this type of tissue, the ability to detect HPV in the lung cancer specimens will be compromised, and the unique opportunity offered by these irreplaceable samples will be lost. Ohio State University and the lab of Dr. Gillison is the only institution in the world with already optimized HPV DNA extraction, purification, and testing methods for EAGLE specimens. Thus, Ohio State University is the only institution qualified to continue the HPV DNA testing for this study to accurately and precisely follow the demonstrated successful procedure which is integral to successfully accomplishing the scientific goal of this study. 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 researcher to determine if the party can perform this requirement. An original and one copy of the capability statement must be received in the contracting office on or before 11:00 am ET on August 27, 2009 to Melissa Marino, Contract Specialist. All questions must be in writing and can be faxed to 301-402-4513 or sent via email to marinome@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, contractors must be registered in and have valid certifications in the Central Contractor Registration (CCR), www.ccr.gov and the Online Representations and Certifications Application (ORCA) www.orca.bpn.gov. Please reference NCI-90157-MM on all correspondence.
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