The National Cancer Institute (NCI), Division of Cancer Epidemiology (DCEG), Hormonal and Reproductive Epidemiology Branch (HREB), plans to enter into a sole source procurement for the Measuring of Humoral Immune Responses Against HPV in the Guanacaste Natural History Cohort and the ASCUS LSIL triage study (ALTS) using archived specimen from two NCI Studies with Deutsches Krebsforschungszentrum (DKFZ), German Cancer Research Center, Technologietransfer; Im Neuenheimer Feld 280; D-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 541711 and the business size standard is 500 employees. The period of performance shall be twelve (12) months from date of award. Two DCEG-based studies, the Guanacaste Natural History Study (NHS) and the ASCUS-LSIL triage study (ALTS) allow analyzing the determinants of seroconversion and antibody-mediated protection. NHS is a population-based cohort of 10,000 women that were followed over seven years with annual cytology, HPV testing, and blood sampling. NHS allows determining factors relevant for seroconversion and studying the protective effect of natural (non vaccine-induced) HPV antibodies. ALTS is a randomized clinical trial of over 5,000 women referred with abnormal cytology results to three management strategies. Follow-up was done over 2 years with cytology and HPV testing every 6 months. Blood samples are available from half of the women (about 2800) at the baseline visit. Due to the high prevalence of disease in a referral population, ALTS complements the efforts in NHS to focus on antibody responses associated with prevalent precancers. Thus, NCI can study the potential protection of women with antibody titers and the induction of antibodies against viral oncoproteins in precancers. The specific objective of the procurement is to determine antibody levels directed against the viral L1, E6, and E7 proteins from the HPV types 16, 18, 31, 33, 35, 45, 52, and 58 in 17,900 plasma samples from archived specimens of two NCI-based studies. The German Cancer Research Center, Heidelberg, has developed a reliable high throughput multiplex assay to measure antibody responses against multiple human papillomavirus proteins, including the 8 most frequent carcinogenic types. This assay detects antibodies directed against 24 HPV epitopes from as little as 50ul serum or plasma. The assay is very sensitive and gives quantitative results over a wide dynamic range. Currently, there is no other assay available that can measure antibodies directed against the L1, E6, and E7 proteins from HPV16, 18, 31, 33, 35, 45, 52, and 58. There are other assays for HPV16 and 18, but they only target the L1 protein and lack the other types. Thus, the German Cancer Research Center, Heidelberg, is the only source to perform the required analyses. At the recent International HPV meeting attended by more than 2000 delegates and multiple companies from around the world, including all scientific and commercial leaders in the HPV field, it was confirmed that no comparable assay was available elsewhere. This is not a solicitation for competitive quotations. However, if any interested party believes it can perform the requirement as detailed they may submit a statement of capabilities. All information furnished shall be in writing and must contain sufficient details 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 contracting office on or before 11:00 am ET, on September 3, 2009. All questions must be in writing and must be emailed to Karri Mares, [email protected] or faxed to (301) 402-4513. 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 from the NCI, contractors must be registered in the Online Representations and Certifications Applications (ORCA). Please refer to http://orca.bpn.gov In addition; contractors must be registered in the Central Contractor Registration (CCR) www.ccr.gov. No collect calls will be accepted. Please reference NCI-90194-KM on all correspondence.

Bid Protests Not Available