Identifying miRNA Signatures as Biodosimetry Biomarkers

Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive Room 1E154 Bethesda, MD 20892 Description: The National Cancer Institute (NCI), Center for Cancer Research (CCR), Radiation Oncology Branch (ROB) plans to procure on a sole source basis analysis of samples using Agilent mRNA and miRNA microarray from GenUs Biosystems, 1807 Janke Drive, Unit M, Northbrook, IL 60062 The products herein are being procured in accordance with the simplified acquisition procedures as authorized by FAR Part 13.106-1 (b) (1). The North American Industry Classification System code is 541380 and the small business standard is $14 million. Only one (1) award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. It has been determined there are no opportunities to acquire green products or services for this procurement. Period of Performance shall be from award through two (2) months. The CCR/ROB has had a long-standing interest in radiation modifiers, particularly on aspects of the stress response. The NCI lab analyzed miRNA expression in LNCaP, PC3 and DU145 prostate cancer cells treated with single-dose (SD) and multi-fraction (MF) radiation by microarray to identify miRNA biomarker signatures for predicting the radiation therapy prognosis/outcome. MF radiation significantly altered more miRNAs compared to SD indicating possible involvement of different pathways in these two methods of treatment. Clearly, expression of miRNAs varies depending on parameters like cell type, time after radiation and radiation dose. Based on the miRNA alteration in tumor cells, the NCI studied the effect of radiation in normal human coronary artery endothelial cells (HCAEC), normal prostate epithelial cells (RWPE1), and normal human fibroblast cells (MRC9). Ultimately, a combined approach of identifying plasma-based biomarkers by assessing functional miRNA, target mRNAs and the resulting proteins to assess radiation exposure after mass-casualty incidents could provide a valuable tool in developing and implementing effective and timely medical countermeasures. This particular work is a continuation of the previous study using the mRNA, miRNA and proteomic analysis in LNCaP, PC3 and DU145 prostate carcinoma cell lines. Hypothesis: Radiation response involves different pathways for different doses of radiation hence different miRNA expression profiles are induced. To determine the time- and dose-response kinetics of differentially expressed miRNA profiles in blood of whole-body irradiated mice: Ionizing radiation induces DNA double strand breaks, which activate signal transduction processes that lead to cell cycle arrest, apoptosis or DNA-repair. Numerous proteins are involved in these multiple pathways at different levels. Recent studies focused on changes in miRNA profiles given that a single miRNA can modulate the expression of several hundred proteins involved in radiation response. A key miRNA, miR-34 has been implicated in radiation response in several studies. The NCI's preliminary studies with prostate cancer cells also indicate that miR-34a is induced after radiation. The NCI hopes to identify additional potential radiation induced miRNAs for developing biomarker signatures to assess radiation dose. These could be investigated in endothelial cells and fibroblasts as the former are long-lived and obviously exposed to the blood and the latter are active in tissue response including wound healing and therefore, would be potential contributors to the miRNA profile in blood. GenUs is a company that provides full service gene expression analysis using the Agilent Bioarray technology. GenUs uses GeneSpring analysis software from Agilent for data analysis allowing for the comparison of current and future experiments with past experiments conducted at GenUs. The company provides amplification of the RNA provided by the NCI laboratory, probe synthesis, hybridization to Agilent microarrys, scanning of the microarrays, and data analysis. GenUs is the only lab that the NCI is aware of that provides high performance microarray metrics for sensitivity, dynamic range, and reproducibility with extremely small amounts of starting material. The analysis is conducted using GeneSpring software, which is one of the leading microarray data analysis packages available today. Since accuracy, reproducibility, and continuing access to GenUs' data analysis expertise are critical to the NCI's drug discovery and development programs, the NCI has chosen GenUs services and Agilent microarrays to meet the NCI's requirements. Due to variability and limited size of samples, the ability to generate consistent results from difficult sample conditions is a requirement. In order to be able to expand and complete the ongoing research using established treatments, the microarray analysis must be compatible with previous experiments. Changing variables at this time will be detrimental to current gene expression analysis being performed in the NCI laboratory. This is not a solicitation for competitive quotations. However, if any interested party, particularly 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. An original and one copy of the capability statement must be received in the NCI contracting office on or before 11:00 AM EST on August 27, 2013. No electronic capability statements will be accepted (i.e. email or fax); an original and one copy must be sent to the NCI contracting office to the address stated above. All questions must be in writing and can be faxed (240)-276-5401 or emailed to Anh-Huy Nguyen, 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 System for Award Management (SAM) at www.sam.gov. No collect calls will be accepted. Please reference solicitation number NCI-130120-HN on all correspondences.