Inactive

The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Infections and Immuno... The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Infections and Immunoepidemiology Branch (IIB) intends to procure, on a sole source basis, the immune profiling of assays on 800 blood samples from Arizona State University (ASU), 660 S MILL AVE STE 312, Tempe, AZ 85281-3670. The response close date of the notice for this requirement is in accordance with FAR 5.203(b). This acquisition will be processed under FAR Part 12 – Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1(b)(1); and is exempt from the requirements of FAR Part 6. The North American Industry Classification System (NAICS) code is 541380 and the business size standard is $16.5 million. 1.0 BACKGROUND The Epstein-Barr virus (EBV) is implicated in gastric carcinogenesis, as about 10% of gastric tumors contain viral nucleic acids and exhibit demographic and clinicopathologic differences from EBV-negative tumors. Humoral profiles of Helicobacter pylori and EBV may reveal infectious, environmental and/or host factors underlying the roles of these pathogens in gastric carcinogenesis. A novel protein microarray technology, called Nucleic Acid-Programmable Protein Array (NAPPA), is a type of cell-free protein array technology which enables more rapid and comprehensive analysis of antigens by performing in vitro synthesis of the target proteins from their DNA templates replacing the conventional complex protein purification process. 1.1 OBJECTIVE The primary objective of the study is to confirm and extend anti-EBV antibody profiles that characterize EBV-positive and EBV-negative gastric tumors and premalignant lesions. 2.0 SCOPE The Contractor shall immune-profile antibody levels in 800 blood samples using NAPPA assays according to the tasks outlined in Section 3.0 below. 3.0 PURCHASE ORDER REQUIREMENTS Task 3.1 The Contractor shall construct NAPPA microarrays by in situ transcription and translation of a total of 340 EBV and H. pylori antigens from DNASU clones in a NAPPA compatible pANT7-cGST expression vector. Expression levels of all microbial proteins shall exceed no DNA wells (mean+3 standard deviations), as confirmed by a monoclonal mouse anti-GST antibody. Task 3.2 Using these arrays (Task 4.1), the Contractor shall evaluate specific antibodies in 800 blood samples to be provided by NCI. Arrays shall be probed with 1:100 diluted plasma followed by incubation with 1:200 diluted Alex647 labeled Goat anti-human IgG (H+L) and 1:200 diluted Cy3 labeled Goat anti-human IgA (Jackson ImmunoResearch Labs, PA, USA), to evaluate specific anti-EBV and -H. pylori IgG and IgA antibodies. Antibody binding signals shall be detected with a bi-color Tecan PowerScanner (Tecan Group Ltd., Männedorf, Switzerland) at 635 nm and 532 nm as two separate images and further analyzed with ArrayPro Analyzer Software (Media Cybernetics, Inc., MD, USA) to generate raw fluorescence intensity data. A pooled plasma that combines all samples shall be probed along with individual samples on each run day to determine array reproducibility. The inter-slide correlation coefficient r for pooled samples shall be at least 0.95 or the assay shall be repeated using residual sample material at no additional charge. Task 3.3 Antibody responses on NAPPA shall be analyzed as Median Normalized Intensity (MNI) via dividing by the median signal intensity of all proteins within each array. Seropositive responses shall be defined as MNI ? 2.0. Test results shall be reported as both quantitative MNI and qualitative seropositivity for each antigen. Task 3.4 When the final deliverable is received and accepted by NCI, the Contractor shall return any remaining sample material on dry ice, to be shipped by a commercial carrier at the Government’s expense. 4.0 TYPE OF ORDER This is a firm fixed price purchase order for non-severable services. The services specified in each contract line item (CLIN) have been determined to be non-severable services - a specific undertaking or entire job with a defined end product of value to the Government. 5.0 PERIOD OF PERFORMANCE The anticipated period of performance shall be for twelve (12) months from the date of award. 6.0 PLACE OF PERFORMANCE All work shall be performed at the Contractor’s facility. 7.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE The Contractor shall submit the test results in a Microsoft Excel-compatible file for review, comment, and approval by the NCI Technical Point of Contact (TPOC). Final copies of the approved draft(s) shall be delivered to the TPOC within five (5) business days after receipt of the Government’s comments. If no comments or requests for revisions are provided within 14 business days, the deliverables shall be considered acceptable. Deliverable #1 – Due ten (10) months after date of award: Electronic data file with NAPPA test results for submitted samples in accordance with Section 3.0 above. Deliverable #2 - Within two (2) weeks of the approved final report The Contractor shall coordinate with the TPOC to send the residual samples to the NCI repository (address below) on dry ice using overnight shipping. Return shipping and handling costs are not included in the purchase order. NCI at Frederick Central Repository American Type Culture Collection (ATCC) 4600 Wedgewood Blvd, Suite H & K 8.0 UNIQUE QUALIFICATIONS OF THE CONTRACTOR Under previous awards HHSN261201800436P and 75N91020P00657, ASU developed and validated novel assays for antibodies directed against EBV. These assays were further characterized using informative samples from patients with EBV positive and negative cancers. The current requirement is a continuation of this line of NCI research and Contractor services, exploiting these assays to investigate viral etiology of gastric cancer and other malignancies. It is critical to use the same laboratory, equipment, DNA sample handling approach, quality control approach, and data processing to ensure the scientific comparability of the new data with the previous data. Any deviation from the proposed acquisition strategy would result in the NCI being unable to combine the results provided under the subsequent award with the results provided under the previous award numbers HHSN261201800436P and 75N91020P00657, as the findings would not be scientifically comparable. 9.0 RESPONSE INSTRUCTIONS This notice is not a request for competitive quotations. However, if any interested party, especially a small business, believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in enough detail to allow NCI to determine if the party can perform the requirement. All responses must be submitted via email to Contracting Officer, Adam Hernandez, at adam.hernandez@nih.gov. Responses are due no later than 11:00 A.M. ET Wednesday, June 02, 2021 (06/02/2021). 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 determining whether to conduct a competitive procurement. To receive an award, Contractors must be registered and have valid certification in the System for Award Management (SAM) through SAM.gov, and have Representations and Certifications filled out. Reference 75N91021Q00104 on all correspondence.