SOLICITATION NOTICE
H -- HPV Testing by Linear Array
- Notice Date
- 6/2/2006
- Notice Type
- Solicitation Notice
- 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, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- Reference-Number-NCI-60073-NV
- Response Due
- 6/13/2006
- Archive Date
- 6/28/2006
- Description
- The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Hormonal and Reproductive Epidemiology Branch (HREB) plans to procure on a sole source basis with John Hopkins University, 615 N. Wolfe St., Baltimore, MD 21205 for continued laboratory services to perform assay testing for several large studies. The HREB is working on a series of projects to evaluate new human papillomavirus (HPV) DNA diagnostics for cervical cancer screening and epidemiologic/clinical/prevention studies of cervical cancer that require HPB DNA testing. The projects include: Project 1. AMPLICOR and Linear Array for the triage of equivocal Pap smears (ASCUS and LSIL Triage Study [ALTS]). John Hopkins University shall evaluate the clinical performance of LA and AMPLICOR for detection of CIN3+ and confirm HPV16 positivity as a biomarker of high-risk of CIN3+ among women who have ASCUS cytology; Project 2. Evaluation of SPF10/LIPA assay for the Costa Rica HPV16 and HPV18 L1 VLP Vaccine Trial. John Hopkins shall verify the analytic sensitivity of SPF/LIPA for detection of HPV DNA and compare to LA.; and Project 3. HPV Testing to Improve Cervical Cancer Screening in the Mississippi Delta: The Mississippi Delta Project (MDP). MDP is a demonstration project to examine the technical feasibility of combining self-collection with HPV DNA testing as a clinically acceptable alternative to cytology for women living in the Mississippi Delta, a medically underserved population and John Hopkins shall HC2 test specimens collected by new sampling devices to determine whether these devices provide any apparent advantage over Dacron swabs for detection of HPV, Provide HC2 and AMPLICOR testing of MDP specimens in accordance with the main objectives of the study, which is to evaluate whether self-collection and HPV DNA testing achieves at least similar clinical performance to cytology-based methods, and use LA to understand test positivity in MDP and adjudicate discordant test results for the two tests. John Hopkins University was one of the developers of the PGMY09/11 assay that became the Linear Array and they are uniquely able to interpret and trouble-shoot this assay. They have an automated DNA extraction robot that is required and compatible with the PCR-based assays being used in this project. Since a lot of this testing is extremely complex, including the real time testing of some specimens, the NCI and support-contract personnel need to be able reach the testing lab on short notice and with ease. The proximity of the Hopkins lab makes this possible. Johns Hopkins University has been a collaborator with the NCI on HPV-related projects since the early 1990?s. To introduce another testing laboratory at this time would be detrimental to the continuity of the research in progress. John Hopkins University is the only vendor known to the HREB that can process these samples without the introduction of new variables into ongoing research. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.5 to use simplified procedures for commercial acquisitions. This is not a solicitation for competitive quotations. However, if any interested party believes it can provide the above service, without introducing new variables into an ongoing research experiments 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 NCI to determine if the party can perform the requirement. An original and one copy of the capability statements must be received in the contracting office by 1:00 p.m. EDT, on June 13, 2006. Faxed and emailed capability statements are NOT authorized. All questions must be in writing and can be faxed to (301) 402-4513 or emailed to dm170b@nih.gov. It is the vendor's responsibility to call (301) 402-4509 to verify 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. In order to receive an award from the NCI contractors must be registered in the Online Representations and Certifications Applications (ORCA). Please refer to http://orca.bpn.gov in order to register. In addition, contractors must be registered in the Central Contractor Registration (CCR) www.ccr.gov. No collect calls will be accepted. NAICS 541380. Size Standard 6M
- Record
- SN01061309-W 20060604/060602220456 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |