SOLICITATION NOTICE
B -- Metabolome analysis of fresh-frozen breast & surrounding tissues
- Notice Date
- 12/2/2009
- Notice Type
- Presolicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-100016-AV
- Archive Date
- 1/1/2010
- Point of Contact
- Ashley L. Virts,
- E-Mail Address
-
virtsa@mail.nih.gov
(virtsa@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Human Carcinogenesis (LHR) plans to procure on a sole source basis for services with Metabolon, Inc.; 800 Capitola Ste. 1; Durham, NC 27713-4385. The services herein are being procured in accordance with the simplified acquisition procedures authorized by FAR Part 13.106-1 (b)(1). The North American Industry Classification System Code is 621511 the business size standard is 12.5M employees. The period of performance for this procurement shall be for four months from December 15, 2009 through March 15, 2010. The Laboratory of Human Carcinogenesis is seeking a comprehensive qualitative and quantitative metabolome analysis of 132 fresh-frozen human breast tissues including sample preparation, technical replicates, application of Liquid chromatography/Mass spectrometry (LC/MS) and Gas chromatography/Mass spectrometry (GC/MS) for metabolite discovery, data extraction and quality assurance, data normalization, bioinformatics and metabolite identification; also required is a full statistical analysis of the resulting dataset for class comparison and the discovery of profiles predictive for breast cancer survival and response to therapy. The proposed work seeks to identify metabolomic differences in tumor biology between African-American and European-American patients that may either influence the presentation of the disease (e.g., causing a more aggressive disease among AA patients), or influence the response to therapy (e.g., causing an inferior response among AA patients). This work has also the potential of discovering novel biomarkers for breast cancer. Not all segments of the U.S. population have equally benefited from the advances in our knowledge and treatment of cancer. Additional efforts are urgently needed to identify and fully understand the causes for the survival health disparity in breast cancer between African-American and European-American patients. Thus, it is vital that new approaches are being used, such as the analysis of the breast tumor metabolome, which has the promise of discovering prognostic markers and targets for therapy within and across different patient groups, as well as for elucidating what drives the aggressiveness of breast cancer in African-American women. The contractor shall perform the following tasks. 1. Keep and store each sample received at -80 C until processed. Enter received samples into a Laboratory Information Management System and assign unique identifiers to track handling and results. 2. Process samples to obtain the sample metabolome using automated platforms to avoid handling differences in sample preparation. Use organic and aqueous extractions to remove the protein, DNA and RNA fractions but serve to maximize the recovery of small molecules from human breast tissue. Add recovery standards prior to the first step in the extraction process for quality control purposes. 3. Prepare metabolome extracts to be analyzed by both LC/MS and GC/MS. Prepare technical replicates. Generate accurate mass measurements of the metabolites in these extracts via LC/MS or GC/MS. Perform QC analysis. Identify metabolites from LC/MS and GC/MS by comparison to library entries of purified standards. The library should contain at least 1500 to 2000 known metabolites and the Contractor must have the capability to routinely identify and quantify at least 1500 tissue metabolites based on the analysis of a 50 mg fresh-frozen tissue piece. Identification should include a combination of chromatographic properties and mass spectra. Contractor should be able to identify unknown metabolites. 4. Use bioinformatics to determine the relative abundance (concentration) of at least 1500 known metabolites in the human samples. Relative abundance of metabolites for one sample should be fully comparable to the abundance of those metabolites in another sample to assure that unbiased abundance differences can be calculated across all samples, excluding sample preparation biases and day to day processing biases. The Contractor should have data normalization steps in place to correct for variations from instrument inter-day tuning differences. 5. Provide a summary in data file form of the relative abundance of all measured metabolites in the 132 samples as well as the results of the statistical and pathway analysis for the metabolites. A full statistical analysis of the resulting dataset for class comparison of at least 20 markers and calculation of fold differences and p- and q-values for class comparisons and pathway associations for disease-associated metabolites (e.g., comparing African-American with European-American patients, estrogen receptor-negative with estrogen receptor-positive tumors, HER2-negative with HER2-positive tumors etc.), and the discovery of profiles predictive for breast cancer survival and response to therapy. This summary document shall be provided within 4 months after the Contractor has received the samples for the metabolome analysis. Metabolon is a company at the forefront of metabolomics research and has the equipment and statistical tools for large-scale measurements of metabolites in human tissue and their comprehensive statistical analysis. Their technology is proprietary and their ability to identify metabolites in human tissue samples is unmatched in academia and industry. Their services, which include running of the samples through HPLC columns, identification of known and unknown metabolites and pathway analysis, are not provided through any other company. Metabolon is the only company which can routinely identify a large number of metabolites to determine their concentration, and provide these measurements at the high quality necessary for the study. Metabolon has a proven track record of being able to successfully complete these measurements, as demonstrated by publications in the peer-reviewed scientific literature. There is currently no other known source to the NCI that is able to complete the work outlined in this procurement. This is not a solicitation for competitive quotations. However, if any interested party believes 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 December 17, 2009. 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 (301) 402-4513 or emailed to Ashley Virts, Contract Specialist at virtsa@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 in the Central Contractor Registration (CCR) www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov. No collect calls will be accepted. Please reference solicitation number NCI-¬¬¬¬-100016-AV on all correspondences.
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