SOLICITATION NOTICE
B -- Epidemiology Study of True Immunity to HPV Infection Using a Novel Serology Assay
- Notice Date
- 8/25/2009
- 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, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-90215-KM
- Archive Date
- 9/24/2009
- 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
(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), plans to procure on a sole source basis an Epidemiology Study of True Immunity to HPV Infection Using a Novel Serology Assay from PPD Vaccines & Biologics, 466 Devon Park Drive, Wayne, PA 19087. 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 $12 M. The period of performance shall be twelve (12) months from date of award. The purpose of the procurement is to study the epidemiology of true immunity to human papillomavirus (HPV) infection in relationship to risk of cervical intraepithelial neoplasia (CIN) in NCI cohort studies, using a newly available serology assay to test archived specimens. Previous assays were inaccurate measures of exposure (<50% seroconversion among women known to be exposed), and did not indicate immunity to subsequent infection or CIN. The NCI stopped using HPV serology for natural history studies and banked the blood specimens from NCI cohort studies awaiting better assays. The Esser Laboratory at PPD has made commercially available a competitive immunoassay that can detect immunity to subsequent HPV infection by measuring neutralizing antibodies that are part of the polyclonal immune response. Far fewer women are positive in this assay than in the serology assays we have used before. Unpublished data from unvaccinated women in the control group of the Merck vaccine trials demonstrate that unvaccinated women testing positive on the Esser assay are at extremely low risk of subsequent HPV infection and CIN for the 4 HPV types (HPV 6, 11, 16, 18) covered by the assay. Thus, this is the first known measure of true immunity to HPV infection and its sequelae (although it is not sensitive for exposure to HPV). This project will study the epidemiology of true immunity to HPV infection and CIN in NCI cohort studies, using a newly available serology assay. Specifically, the contractor shall test 911 archived plasma specimens from the Guanacaste Study, a natural history cohort study of HPV and cervical neoplasia. The first 100 specimens will be used to validate the method to be used in converting plasma to serum for the assay; the remaining 811 specimens will be less expensive to test because the assay conditions will be established. All 911 specimens have been chosen in a nested case-control manner to permit multiple epidemiologic analyses related to determinants of HPV seroconversion, and relationship of seropositivity to subsequent risk of new HPV infection and its sequelae. The Esser Laboratory, while a part of Merck, before the sale to PPD, invented the assay needed for the project, and PPD now has intellectual property rights for its use. No other laboratory is permitted to use the assay, and the NCI has no other means to perform the work scope. At a recent International HPV Workshop, it was confirmed that no other laboratory offers a comparable assay. Accordingly, PPD Vaccines & Biologics is the only source available from the NCI to acquire the novel serology assay needed to complete this project. 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 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. EST on September 9, 2009. All questions must be in writing and can be faxed to 301-402-4513 or sent via email to Karri Mares maresk@mail.nih.gov. It is the vendor’s responsibility to ensure questions have been received by the contract specialist. 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, updated registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Application (ORCA). Please reference solicitation No. NCI-90215-KM on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/NCI-90215-KM/listing.html)
- Record
- SN01925734-W 20090827/090826000900-004a5e6a250cdaae6ae7e305c2ec283c (fbodaily.com)
- Source
-
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