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Biomarkers of progression of oral leukoplakia to oral cancer.

General Information

Document Type:PRESOL
Posted Date:Aug 24, 2017
Category: Special Studies and Analyses - Not R&D
Set Aside:N/A

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States


Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E224, Bethesda, MD 20852, UNITED STATES. Description The National Cancer Institute (NCI), Division of Cancer Epidemiology & Genetics (DCEG), Epidemiology and Biostatistics Program (EBP), Infections and Immunoepidemiology Branch (IIB) plans to procure on a sole source basis services to test plasma samples for 1,150 subjects from the NCI Ghana and EMBLEM Burkitt Lymphoma studies for malaria antibodies with the Center for Medical Parasitology, University of Copenhagen, 1014 Copenhagen K, Denmark. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1 (b)(1) using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System (NAICS) code is 541990 and the business size standard is $15.0 Million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance shall be as follows: 12-months from date of award. It has been determined that there is no opportunity to acquire green products or services under this contract. The purpose of the procurement is to test plasma samples for 1,150 subjects from the NCI Ghana and EMBLEM Burkitt Lymphoma studies for malaria antibodies. Specifically, to use a custom-built Luminex bead assay to evaluate serological responses to 15 nominated Plasmodium falciparum erythrocyte membrane protein 1 (PfEMP1) antigens, 6 previously evaluated malaria antigens (AMA1, MSP1, CSP1/GLURP, SERA5, HRP-2, and 6NANP) and 2 irrelevant antigens (Tetanus, & BSA) among 1,150 samples provided by the NCI. An additional 115 vials will be provided as quality control samples. Although Plasmodium falciparum (Pf) malaria is an important risk factor for endemic Burkitt lymphoma (BL), the evidence for carcinogenicity remains incomplete. The major limitations include the small number of epidemiological studies conducted to evaluate malaria infection in children with and without BL. These studies have evaluated antibodies to three antigens, none of which are associated with malaria virulence. Specifically, the severity of malaria is linked to the expression of specific parasite derived adhesion proteins, called Pf erythrocyte membrane protein 1 (PfEMP1), which are expressed on cell surface of infected red blood cells. These proteins bind to human endothelial membrane cell receptors and cause adherence and sequestration of infected red blood cells. This binding causes vascular blockage and increases local inflammation, which is responsible for the symptoms of severe malaria, such as severe anemia or cerebral disease (coma). The development of antibodies to these proteins reduces the severity of malaria symptoms and ultimately reduces the instances of asymptomatic malaria. While serological profiles for PfEMP1 have been evaluated for severe malaria, it has not been assessed in children with or without BL. Better understanding of the serological profiles to these virulent malaria proteins would enable a rational approach to malaria intervention to reduce mortality of BL in endemic populations. This procurement requires malaria immunology expertise, particularly with respect to the PfEMP1 antigens. This expertise involves the production of the antigens in insect cell-based expression systems, coupling those antigens to spheres and then evaluating serological reactivity in human plasma samples. The University of Copenhagen is a world-leading expert on PfEMP1 antigens whose lab has characterized these antigens in malaria samples and evaluated serological patterns in human populations internationally. The Contractor has developed and validated the Luminex assay that will be used in this work. For these reasons the Contractor is the only known sole source for this procurement. The Contractor shall provide the following tasks: - The Contractor shall manufacture the PfEMP1 Luminex bead assay kits comprising 15 PfEMP1 proteins, as agreed upon between the NCI and University of Copenhagen, 6 previously characterized malaria antigens (AMA1, MSP1, CSP1/GLURP, SERA5, HRP-2, and 6NANP) and 2 irrelevant antigens (Tetanus, & BSA). - The Contractor shall purchase and couple to Luminex sphere and validate the assay. Test up to 1,150 patient samples provided by the NCI, 115 quality control samples, and any appropriate internal positive and negative quality control samples using the Luminex bead assay kits manufactured above. The Contractor shall review the results and assist in bioinformatics analysis of the results. Government responsibilities The NCI investigators will work with the Contractor to finalize the selection of PfEMP1 and irrelevant antigens for inclusion in the assay. The NCI investigators will provide advice on statistical models and review interim results. Reporting requirements and deliverables Each deliverable shall be provided in electronic form by email to the Project Officer. Files listing subjects or samples shall be provided as Excel files. Other reports shall be provided as Word documents. Deliverable: Shall include an excel spreadsheet of the results for the antigens included in the Luminex assay and a detailed report about assay performance. Due date: 12 months from date of award. Inspection and acceptance criteria 1. The Government will have 30 days for inspection of each deliverable. 2. The Government will issue payment for each deliverable following acceptance of the deliverable. This is not a solicitation for competitive quotations. However, if any interested parties, especially small businesses, believe 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. A copy of the capability statement must be received in the NCI Office of Acquisition on or before 11:00AM EST on September 1, 2017. All questions must be in writing and can be faxed (240) 276-5401 or emailed to Kathy Elliott, Contract Specialist at Elliottk@mail.nih.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 on Sam.gov, www.sam.gov. No collect calls will be accepted. Please reference solicitation number N02CP72671-61 on all correspondence.

Original Point of Contact

POC KATHY D. ELLIOTT, Phone: 240-276-5570, Reyes Rodriguez, Phone: 240-276-5442

Place of Performance

9609 Medical Center Drive, Rockville, Maryland, 20850, United States
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