The National Institute on Drug Abuse (NIDA), Office of Acquisitions, Station Support Simplified Acquisitions Branch on behalf of the National Institute of Neurological Disorders and Stroke (NINDS) plans to procure, on a non-competitive basis, DNA Analysis of Biomarkers from patients in an MS study from Translational Genomics Research Institute (TGen), 445 N. 5th Street, Phoenix, AZ 85004. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority of FAR 13.106-1(b)(1) and FAR 13.501 (a)(1) to use Simplified Acquisition Procedure for commercial items. The North American Industry Classification System Code for this acquisition is 541711 and the business size standard is 500 employees. The NINDS Division of Intramural Research (DIR)-Viral Immunology Section (VIS) works to identify biomarkers by single nucleotide polymorphism (SNP) haplotype determination and link these with clinical and MRI phenotypes in a large cohort of relapsing-remitting (RR-) MS patients and to identify biomarkers that separate MS patients and healthy, matched controls. Up to 1,000 patients have been enrolled in and treated under a multi-center trial of combination therapy (MS-CombiRx) using two approved disease-modifying therapies (interferon-beta, IFN-b, Avonex; glatiramer-acetate, GA) as single treatments or in combination. In addition, 200 healthy, matched control individuals are also being recruited. The results of the biomarker studies will be assessed in relationship to both the clinical and MRI phenotype at baseline and to change in disability, relapse rate, response to therapy and change in MRI measures of disease during the 3-year treatment period. Each of the biomarker study components will be analyzed with respect to biomarkers that discriminate between MS patients and controls. Similar to rheumatoid arthritis or autoimmune diabetes, multiple sclerosis (MS) is considered a complex disease with autoimmune pathogenesis as well as vulnerability of the target tissue, i.e. the central nervous system (CNS). The results of the biomarker study should provide a better understanding of the disease pathogenesis, of the inter-individual disease heterogeneity, and finally identify biomarkers such as gene signatures and individual genes that are correlated with responsiveness or non-responsiveness to single drug treatment or the combination of the two drugs. Initial studies examining the value of genome wide analysis in multiple sclerosis using samples obtained from the BiomarkerMS project was approached as a collaboration between investigators in Barcelona and the BiomarkerMS project as well as investigators at TGen. Several hundred NIH samples were provided for this analysis. The approaches involved a pooled genome wide scan of 500,000 SNPs. The results were published in PLoS One 2008;3(10):e3490. The results indicated that in addition to SNP rs3129934 on chromosome 6 in the MHC region the next strongest association was found for a SNP on chromosome 13. The region identified on chromosome 13 has not been previously identified. The findings support the approach used in this preliminary collaboration. Because of the success of this preliminary work, it is determined that the analysis of the entire BiomarkerMS data set to be continued with investigators at TGen. It is important that the future results be as consistent as possible with the preliminary results obtained to date. TGen is the world leader in analyzing single nucleotide polymorphisms (SNPs) to identify disease-causing genes, associations, and DNA signatures, all of which have profound implications for detection, prognosis and therapeutic intervention. The TGen SNP Genotyping Center offers innovative solutions that address the requirements for flexibility, simplicity, throughput, economy, and accuracy. TGen has successfully completed a pilot project of 100 samples obtained from the MS-CombiRx study. SNP analysis was performed on an Illumina Infinium Human Omni1 platform. This pilot program was done in a timely and efficient manner and it is clearly that TGen can provide the necessary bioinformatic support for the on-going study. Based on this preliminary and encouraging findings of this pilot program as well as the expertise and world class reputation that TGen has in this field of investigation, it is imperative that TGen complete the analysis of the remaining samples in the MS-CombiRx study. Moreover, the clinical samples are limited and irreplaceable, it is crucial to have TGen continue performing and complete the analysis. To award a contract to a new and different vendor to perform this ongoing analysis will further delay the ongoing project and in turn costs the Government more to have the study completed. Delivery shall be FOB Destination, Bethesda, MD. Period of performance will last a minimum of one (1) year and will expire two (2) years from the effective date of the project. No solicitation package will be issued. This notice of intent is not a request for competitive quotations; however, the Government will consider responses submitted to
contact@example.gov on or before 1:00 PM ET March 12, 2010. All information furnished must be in writing and must contain sufficient detail to allow the government to determine if it can meet the above specifications described herein. A determination by the Government not to compete the proposed acquisition based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Please reference the announcement number NOI-1449245 on all correspondence.
