SPECIAL NOTICE
B -- human papillomavirus (HPV) 4-Serotype Competitive Luminex Immunoassay (cLIA) to evaluate the antibody response pre-and post-vaccine licensure to HPV types 16, 18, 6 and 11
- Notice Date
- 7/24/2010
- Notice Type
- Special Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2010-Q-12609
- Archive Date
- 8/21/2010
- Point of Contact
- Gary L. Morgan, Phone: (770) 488-2639, Jeff A Miller, Phone: 770-488-2651
- E-Mail Address
-
glm5@cdc.gov, afx2@cdc.gov
(glm5@cdc.gov, afx2@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- The Centers for Disease Control and Prevention intends to issue a sole source purchase order to Pharmaceutical Product Development, Inc. (PPD), Vaccines and Biologics Laboratory, 466 Devon Park Drive, Wayne, PA 19087-1816, for testing services using the human papillomavirus (HPV) 4-Serotype Competitive Luminex Immunoassay (cLIA) to evaluate the antibody response pre-and post-vaccine licensure to HPV types 16, 18, 6 and 11 in samples from the National Health and Nutrition Examination Survey (NHANES) and the HPV Sentinel Surveillance Study. HPV is the most commonly sexually transmitted infection and because of its etiologic role in cervical cancer, is a significant public health issue. HPV is not a single virus, but is a family of more than 100 closely related viruses. High-risk types such as HPV-16 and-18 are associated with cervical cancer where as low-risk HPVs such as HPV-6 and -11 are associated with the production of benign genital warts. In clinical trials vaccines against HPV have been shown to be effective in preventing infection and genital cancer precursors associated with the targeted types. HPV vaccination is now recommended in the US, and monitoring the impact of this vaccine is a key priority. HPV serology is an important tool to determine the baseline exposure of the US population to the vaccine types. The CDC requires a high-throughput assay to measure the type-specific antibody response to the four HPV types targeted by current vaccine formulations; HPV 16 and 18 (Gardasil and Cervarix) and 6 and 11 (Garadasil). Due to limitations in sample volume, the assay must be in a multi-plex format. Additional requirements are that the results be quantitative and measure neutralizing epitopes on L1 viral like particles (VLPs). The competitive Luminex Immunoassay (cLIA), a high-throughput multiplex assay that allows for quantitative measurement of 4 HPV type-specific antibodies against neutralizing epitopes meets this requirement. At this time the CDC laboratory does not have an assay of this capability and therefore the services of a CRO capable of performing cLIA in a time efficient and standardized manner would be greatly beneficial in testing the serum samples collected for various epidemiological studies pre and post vaccine licensure. The reliability of this assay is recognized as it was used in clinical trials determining the safety and efficacy of one of the current licensed HPV vaccines, Gardasil. This procurement will be processed under the authority of FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. The North American Industry Classification System (NAICS) code for this requirement is 541990. No solicitation is being issued. Note 22 applies herein. Interested persons may identify their interest and capability to respond to this requirement. This procurement is not set-aside for small business. For contractual questions no calls will be addressed, please e-mail gmorgan1@cdc.gov to contact Gary Morgan.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2010-Q-12609/listing.html)
- Place of Performance
- Address: Atlanta, Ga 30341, Atlanta, Georgia, 30341, United States
- Zip Code: 30341
- Zip Code: 30341
- Record
- SN02216915-W 20100726/100724233214-2e782d0841966a09721ca2e3fd29b7ee (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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