mRNA and microRNA Microarray Profiling Services for the Prediction of Radiation Therapy Outcomes

The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Radiation Oncology Branch (ROB) plans to procure, on a sole source basis, the continuation of previous studies to understand gene expression changes in MEF cell lines from: GenUs BioSystems Inc 1808 Janke Drive Northbrook, IL 60062 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 code is 541380 Testing Laboratories and the business size standard is $16.5 million. SCOPE See attached Statement of Need (SON). The core strength and sole focus of the vendor GenUs BioSystems Inc is full-service gene expression profiling services on microarrays, using unique and proprietary protocols and systems developed to provide highly sensitive and reproducible results. The vendor's first proprietary processing tier involves a single round of amplification with extremely small amounts of total RNA (50 picogram) to generate enough labeled material to hybridize to microarray platforms. Their second proprietary processing tier utilizes a double amplification process which generates sufficient labeled material for running multiple technical replicates. Extensive qualification and quantification processes ensure high quality results from difficult sample conditions in terms of variability and amount. In addition, this vendor provides comprehensive gene expression data analysis and data interpretation services. To NCI's knowledge, the protocols and systems gene expression profiling services are propriety, unique in nature, and thus solely available through GenUs BioSystems Inc. Furthermore, the NCI has already performed several irradiation biomarker signature studies in different models (mouse, mini pig, whole blood), utilizing GenUs BioSystems gene expression profiling services. Changing variables would be detrimental to ongoing gene expression studies. In order to be able to expand and complete the ongoing research, maintaining consistency utilizing the same analysis protocols and platforms must be used. Only this will allow the NCI to compare the new data with previous results and to integrate them into previous microarray analyses.