PRESOL | A | Services in support of Human Papilomavirus prevalence in Lung Cancer Tumors

FBO DAILY ISSUE OF AUGUST 16, 2008 FBO #2455
SOLICITATION NOTICE

A -- Services in support of Human Papilomavirus prevalence in Lung Cancer Tumors

Notice Date: 8/14/2008
Notice Type: Presolicitation
NAICS: 541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
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-80188-KM
Archive Date: 9/13/2008
Point of Contact: Karri L. Mares,, Phone: 3014357774, Caren N Rasmussen,, Phone: (301) 402-4509
E-Mail Address: maresk@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 services in support of Human Papilomavirus prevalence in Lung Cancer Tumors from Johns Hopkins University, Departments of Oncology & Epidemiology; 1650 Orleans Street, CRB G91 Baltimore, MD 21231. 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 541712 the business size standard is $7 million. The purpose of this contract is to determine the prevalence and functionality of HPV in lung cancer fixed tissue specimens. This data will aid the The Genetic Epidemiology Branch (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 important public health implications. 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,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 contractor shall provide services for measurement of HPV DNA in paraffin-embedded tissue. The DNA detection methods must be sensitive and specific for the detection of a broad range of HPV types, and in particular for HPV16, which causes most HPV-associated cancers, and in situ hybridization must be used to confirm the presence of the virus in the tumor cells as only this approach provides localizing spatial information that may support etiologic involvement of HPV. Information on HPV integration and HPV oncogene expression shall also be provided as an indication of the functionality of any HPV detected. The period of performance shall be one year from date of award. The vendor shall:  1.  Test 450 paraffin-embedded lung tumor tissues for a range of carcinogenic and non-carcinogenic HPV types using PCR with PGMY primers.  2.  Test 450 paraffin-embedded lung tumor tissues for HPV16 using PCR with type-specific primers for the E6 region.  3.  Confirm the presence of HPV in any PCR-positive samples (based on studies performed under No. 1 and No.2) using in situ hybridization (ISH) and evaluate HPV integration based on the ISH staining pattern.  4.  Test for HPV oncogene expression, as measured by p16-overexpression, in all HPV DNA-positive cases (defined by positivity in No. 1 and No. 2) and an age-smoking-gender matched set of HPV-negative cases.  5.  Provide regular updates at EAGLE meetings, data for manuscripts, talks, and discussions with the EAGLE collaborators. Services shall be provided by Johns Hopkins University departments of Oncology and Epidemiology and the laboratory of Dr. Maura Gillison. Dr. Gillison was trained in the laboratory that developed the PGMY09/11 system, a sensitive and specific method to detect a wide range of HPV types. This system is preferable to other PCR assays because it has increased ability to detect specific HPV types, particularly when multiple infections are present, in comparison to other HPV DNA detection methods. The laboratory has experience with lung cancer, as well as cervical and other non-cervical HPV-associated cancers. The work has established Dr. Gillison’s credibility in HPV detection among the HPV experts. Credibility is essential to the success of this project given that many HPV experts simply do not believe study results that have reported high HPV prevalences in lung tumors. Johns Hopkins Laboratory has the necessary equipment to perform all of the assays required: PCR tests for both a broad range of HPV types using PGMY primers and for HPV16 E6 DNA, which is a key step given concerns that disruptions or deletions in the L1 region may lead to false-negative results from L1-based primers; in situ hybridization, and p16-over expression. The JH Laboratory allows completion of all testing in a single, established, credible laboratory. It is critical to contract with one laboratory in order to maximize efficiency, avoid potential errors involved in splitting/combining data and specimens, establish consistent, uniform quality control for all assays, and make the best use of the strictly limited number and irreplaceable nature of the available tissue specimens, as well as to minimize the potential for contamination. The Johns Hopkins Laboratory is the only known laboratory that can verify PGMY and E6 PCR-positive assays with in situ hybridization and has also had experience in processing and testing paraffin-embedded head and neck specimens for HPV. The HPV DNA purification method is critical for HPV detection in head and neck specimens,  and may influence HPV detection in lung cancer specimens as well. This is not a solicitation for competitive quotations. However, if any interested party believes they can meet the above requirement, 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 NCI contracting office by 11:00 AM ET on August 29, 2008. All questions must be in writing and can be faxed (301) 402-4513 or emailed to Karri Mares, Contract Specialist at maresk@mail.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) www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov. No collect calls will be accepted. Please reference NCI-80188-KM on all correspondence.
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A -- Services in support of Human Papilomavirus prevalence in Lung Cancer Tumors