MODIFICATION
B -- Luminex multiplex HPV serological assay testing services
- Notice Date
- 8/31/2009
- Notice Type
- Modification/Amendment
- 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-90125-KM
- Archive Date
- 9/29/2009
- 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), Nutritional Epidemiology Branch (NEB) plans to procure on a sole source basis Luminex multiplex HPV serological assay testing services from Deutsches Krebsforschungszentrum (DKFZ), Im Neuenheimer Feld 280, 69120 Heidelberg, Germany. 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 $13.5 million. The period of performance shall be twelve (12) months from date of award. The Nutritional Epidemiology Branch (NEB), Division of Cancer Epidemiology and Genetics (DCEG), NCI conducts intramural research in areas related to nutrition and cancer aimed at lowering human cancer risk. One focus of NEB research is esophageal cancer, especially esophageal squamous cell carcinoma (ESCC). Human papillomavirus (HPV) is an established cause of squamous cell cancers of the cervix, vulva, anus, penis, tonsil, and oropharynx, but its role in the etiology of ESCC remains unclear. Serological studies have reported ORs of 0.8 to 14.6, and PCR-based studies of case series have reported the prevalence of HPV DNA in ESCC tumor tissue to range from 0 percent to 100 percent. With the new potential to prevent HPV-related diseases by vaccination, it is especially important to determine if this virus is, in fact, involved in ESCC carcinogenesis. Possible sources of variation in serological study results include differences in study design, differences in the serological tests used, and true variation among populations. One way to minimize variations in study design and serological tests is to do one large study in diverse populations using standardized methods and tests. Thus, the NCI recently joined the InterSCOPE Study, a collaboration of ESCC case-control studies from both high- and low-risk populations, to evaluate the association of HPV seropositivity and ESCC risk in approximately 2,000 cases and 5,000 controls from Australia, China, Iran, South Africa, Europe, and South America. All testing will be done by a single lab with a single assay, a Luminex multiplex assay that can identify antibodies to the L1, E6 and E7 proteins of the 8 high risk HPV types that are the most prevalent in cervical and oropharyngeal cancer (16, 18, 31, 33, 35, 45, 52, and 58). All test results will be adjusted for smoking, alcohol consumption and other covariates in a standardized manner. The purpose of this collaborative study is to measure the association between the above HPV serological markers and risk of ESCC in a standard way in both high- and low-risk populations from around the world. This will be the largest and most definitive serological study of this hypothesis ever performed. The purpose of this procurement is to conduct the needed serological tests on the serum samples contributed to the collaboration by DCEG/NCI, including (a) 300 ESCC cases and 300 controls from the Esophageal Cancer Genetics Studies’ Case-Control Study in Shanxi, China, and (b) 300 ESCC cases and 571 controls from the GEMINI Case-Control Study in Golestan, Iran. Specifically, the contractor shall perform Luminex multiplex serological testing for antibodies to the major capsid protein L1 and the oncoproteins E6 and E7 of the following eight high risk mucosal HPV types: 16, 18, 31, 33, 35, 45, 52, and 58, on 1471 serum samples provided by the Government. The contractor shall perform this testing using the same methods that it currently uses to test all serum samples from all studies collaborating in the InterSCOPE Study. The Infections and Cancer Program (F020) at the Deutsches Krebsforschungszentrum (DKFZ), under the direction of Dr. Michael Pawlita, is the only major research laboratory with extensive experience conducting the desired Luminex multiplex HPV serological assays. It is the laboratory that is currently testing all serum samples from all other studies collaborating in the InterSCOPE Study; and thus is the only source that can supply the services required in this procurement. 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 14, 2009. All questions must be in writing and can be faxed to 301-402-4513 or sent via email to Kerri Mares at maresk@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-90125-KM on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/NCI-90125-KM/listing.html)
- Record
- SN01934953-W 20090902/090901003404-c5101aa64d44fc29048acc5e7bff49ed (fbodaily.com)
- Source
-
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