H. pylori multiplex serology testing

Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions9609 Medical Center Dr RM 1E144, Bethesda, MD 20852, UNITED STATES. Description The National Cancer Institute (NCI) plans to procure on a sole source basis with Deutsches Krebsforschungszentrum Im Neuenheimer Feld 280, D-69120 Heidelberg for H. pylori multiplex serology testing. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The North American Industry Classification System code is 541380 and the business size standard is $12 million. It has been determined that there is no opportunity to acquire green products or services under this contract. Helicobacter pylori infection is the strongest known risk factor for gastric cancer. The discrepancy between the large number of people infected with H. pylori and the minority of individuals who develop related malignancies is thought to relate to a complex interplay of environmental and host susceptibility factors as well as differing virulence among H. pylori strains. H. pylori is a particularly heterogeneous and highly adaptable bacterium. Virulence can vary greatly from strain to strain, and strains vary greatly in different geographical locations. A number of bacterial virulence factors have been associated with particular gastric pathologies and the severity of these pathologic conditions. Cytotoxin-associated gene A (CagA) and vacuolating toxin (VacA) have long been established factors associated with more severe disease; recent comparative and immunoproteomic studies have suggested additional H. pylori antigens which may be associated with malignant potential. Deutsches Krebsforschungszentrum (DKFZ) has recently developed a new multiplex serologic assay (based on Luminex fluorescent bead technology) for detecting host antibodies generated against CagA and 14 other H. pylori protein antigens, and has reported data from one cross-sectional study that suggests that some of the other H. pylori proteins may also be significant virulence factors. Finding additional significant virulence factors could be important both for understanding the mechanism of H. pylori - induced carcinogenesis and for better risk-stratification of H. pylori infected individuals. NCI plans to assess the relationship between H. pylori seropositivity in 946 cases and controls from the GEMINI study using both standard ELISA for whole cell H. pylori and a multiplex serology assay. There is existing multiplex serology data for 446 of these cases and controls, while this data is outstanding for 500 cases and controls. There is no prior data on whole cell H. pylori (measured by ELISA) seropositivity for the 946 people, as such, H. pylori whole cell ELISA will be measured for all 946 cases and controls. DKFZ has staff with extensive experience conducting Luminex serological assays, and has designed and optimized the proprietary multiplex Luminex assay for detection of antibodies against 15 H. pylori antigens. Thus, it is THE ONLY SOURCE that can supply the services required in this procurement. This is not a solicitation for competitive quotations. However, if any interested party believes they can meet the above requirement, they may submit a statement of capabilities. All information furnished must be in writing and must contain sufficient detail 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 NCI Office of Acquisitions on or before 11:00 AM EST on June 25, 2013. No electronic capability statements will be accepted (i.e. email or fax), an original and one copy must be sent to the NCI Office of Acquisitions at the address stated above. All questions must be in writing and can be faxed +1 (555) 000-0000 or emailed to Erin Breedlove, Contract Specialist at contact@example.gov. 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, contractors must have valid registration and certification in the Central Contractor Registration (CCR) www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov. No collect calls will be accepted. Please reference solicitation number NCI-130073-EB on all correspondence.