SOURCES SOUGHT
B -- Metabolic pathway analysis on body fluids from patients in the Undiagnosed Disease Program
- Notice Date
- 7/8/2013
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- HHS-NIH-NHLBI-CSB-(HG)-SBSS-2013-205-DLM
- Archive Date
- 7/27/2013
- Point of Contact
- Dorothy Maxwell, Phone: 301-435-0352
- E-Mail Address
-
maxwelld@mail.nih.gov
(maxwelld@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice." A. BACKGROUND : The National Institute of Health (NIH) is the nation's leading medical research agency and the primary Federal agency conducting, supporting and making medical discoveries that improve people's health and save lives. The National Institutes of Health Undiagnosed Disease Program (UDP) is a trans-National Institute of Health (NIH) initiative that focuses on the most puzzling medical cases referred to the NIH Clinical Center in Bethesda, Md. It was organized by the National Human Genome Research Institute (NHGRI), the NIH Office of Rare Diseases Research (ORDR) and the NIH Clinical Center. Many medical specialties from other NIH research centers and institutes contribute the expertise needed to conduct the program, including endocrinology, immunology, oncology, dermatology, dentistry, cardiology and genetics, among the dozens of participating senior attending physicians. A longstanding medical condition that eludes diagnosis by a referring physician can be considered undiagnosed and may be of interest to this clinical research program. B. PURPOSE AND OBJECTIVES : 1. The purpose of this acquisition is to provide metabolic pathway analysis on body fluids from patients in the Undiagnosed Disease Program. This analysis will determine how disease mutations and changes in or accumulation of biomarker compounds elicits patient disease. The Objective is to provide cutting edge methodology for untargeted detection of pathological changes in the lipid glycosylation, protein-glycosylation and metabolic profiles of cerebrospinal fluid from individuals with neurological disorders. C. SCOPE OF WORK : The Contractor must have Clinical Laboratory Improvement Amendments (CLIA) Approval, No Exception and provide a copy of Certification. 1. Contractor shall perform untargeted body fluid organic acid analysis using gas-chromatography mass spectrometry and a deconvolution-separation procedure. • All components in the biological sample must be recognized and spectra be matched to libraries available. • All unrecognized compounds must be analyzed using a combination of gas-chromatography mass-spectrometry and liquid chromatography-tandem mass spectrometry if associated with the patient's disease. 2. Contractor shall perform targeted amino acid analysis using Ultra-Performance Liquid Chromatography on all patient samples. 3. Contractor shall perform a novel UPLC assay on CSF from all patients that can measure down to 1 micromole per liter with a CV of less than 20%. 4. Contractor shall measure glycolipids in the patient samples using LC-MS-MS using a unique assay developed by the Contractor. 5. Contractor shall perform sterol analysis using GC-MS and separation technology. 6. Contractor shall perform untargeted glycomics analysis of CSF measuring free oligosaccharides, N-linked glycan and O-linked glycan profiles using both MALDI-TOF and ESI-QTOF in order to discover undiagnosed glycosylation disease in the patient samples. 7. Contractor shall perform analyses using protocols that are consistent with CLIA-approved patient care by certified technologists. Specific Tasks : 1. Untargeted body fluid organic acid analysis using a gas-chromatography-mass spectrometry (GC-MS) and a deconvolution separation procedure. Unrecognized compounds in a sample will be further analyzed using a combination of GC-MS and liquid chromatography-tandem mass spectrometry (LC-MS-MS) if considered to be associated with the patient's condition. 2. Untargeted glycomics analysis of CSF measuring free oligosaccharides, N-linked glycan and O-linked glycan profiles using both MALDI-TOF and ESI-QTOF technology. 3. Targeted amino acid analysis using Ultra-Performance Liquid Chromatography will be performed on appropriate samples. 4. Measurement of glycolipids using LC-MS-MS on appropriate samples. 5. Sterol analysis by GC-MS on appropriate samples. 6. Coordinate analyses with Dr. Hoppel from Case Western Reserve University. 7. The Contractor shall provide test results in a format that can be integrated with exome sequence variant analysis and support the ongoing collaborative research expertise needed by the UDP. 8. The Contractor shall provide unique services specific to untargeted metabolome and glycome screening of UDP patients as well as appropriate targeted follow-up screening and identification of anomalous compounds deemed associated with the patient's disease. 9. The Contractor's turn-around-time for UDP to receive results will be both untargeted screens on 20 samples per month. 10. The Government will be contacted if any patient results need to be evaluated urgently for impact on caring for patients in the UDP. 11. The Contractor shall supply electronic copies of all reports appropriate for deposition in the UDP process management system and for exome sequence variant analysis. Desired Results/Functions/End Items : 1. Test results with qualified interpretations in a timely way given the requirements of the particular test. 2. Follow-up targeted testing and identification of anomalous compounds will be discussed and mutually agreed upon in a timely manner. 3. In combination with the work of the Contractor, Contractor will collaborate with Case Western University (Dr. Charles Hoppel); UDP will achieve an integrated and comprehensive analysis of the metabolome, glycome, and lipidome of the CSF of UDP patients with neurological problems. 4. Research collaborations will be conducted via Videoconferences, email communications, shared professional presentations, posters and publications. Grand Round presentations at the Contractor's location and the NIH Clinical Center may also occur. Technical Specifications/Standards/Methods : 1. The Contractor shall supply results with qualified interpretations in formats appropriate to the process management systems and for facilitation of other collaborations. Special Handling or Handling Requirements : 1. The Contractor shall provide result reports and record methods and materials as appropriate to the highest scientific standards. These materials, methods and results will be shared with agreed upon UDP collaborators to enable diagnosis of UDP patients. Government Responsibilities : 1. The Government will not furnish any government property to the vendor. 2. The Government will provide access to phenotypes and exome data as needed. 3. The Government will provide patient samples including fibroblasts or pellets of cultured fibroblasts, cerebrospinal fluid, urine, and plasma as the research warrants. 4. The Government will send all patient samples via Fed-Ex overnight to the Contractor for testing. 5. The Government will not furnish any facilities to be used by the vendor. The Government will be responsible for reviewing and approving reports and similar matters generated: 1. Results will be provided electronically to the UDP via secure email, the UDP ftp site or direct deposition into the UDP process management system. 2. Results will also be shared with UDP collaborators as defined mutually. Reporting Requirements and Deliverables : 1. The Government will receive all electronic results quarterly. 2. The Government will receive additional reports for any test added-on after the Contractor receives the original specimen. 3. The Government will receive additional reports for any parental or sibling testing done for the clarification of a new genetic disease. D. OTHER CONSIDERATIONS : The Contractor shall provide: 1. untargeted body fluid organic acid analysis using a gas-chromatography-mass spectrometry (GC-MS) and a deconvolution separation procedure; 2. untargeted glycomics analysis of CSF measuring free oligosaccharides, N-linked glycan and O-linked glycan profiles using both MALDI-TOF and ESI-QTOF technology, and as appropriate targeted analysis of; 3. glycolipids using LC-MS-MS; 4. sterol analysis by GC-MS, and 5. amino acids using Ultra-Performance Liquid Chromatography. E. Anticipated Period of Performance: Twelve (12) months from the date of award. F. Capability Statement /Information: Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. The following information shall be included in the capability statement: 1. A general overview of the respondents' opinions about the difficulty and /or feasibility of the potential requirement, and any information regarding innovative ideas or concepts. 2. Information in sufficient details of the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. The respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the North American Industry Classification System (NAICS) code: 541712 Research and Development in the Physical, Engineering, and Life Sciences (except biotechnology). Any other information that may be helpful in developing or finalizing the requirements of the potential acquisition. The capability statement shall not exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, in either Microsoft Word or Adobe Portable Document Format (PDF), with 8-1/2 by 11 inch paper size, and 1 inch top, bottom, left and right margins. All proprietary information should be marked as such. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. G. CLOSING STATEMENT: The capability statement should be submitted electronically (via email) to Dorothy Maxwell, Contract Specialist, at maxwelld@mail.nih.gov, on or below July 12, 2013, 7:30 AM, EST. All responses must be received by the specified due date and time in order to be considered. This Sources Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Heart, Lung, and Blood Institute (NHLBI). The NHLBI does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this notice, the NHLBI may issue a Request for Quote (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. "Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-(HG)-SBSS-2013-205-DLM/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03110306-W 20130710/130708234951-c6c06b4258785f5422544a08205370cd (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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