SOURCES SOUGHT
B -- Predictive Blood and Cerebrospinal Fluid Metabolomic Markers in Alzheimer’s Disease
- Notice Date
- 2/23/2015
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211 - MSC 9559, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-SS-2015-152
- Archive Date
- 3/20/2015
- Point of Contact
- Samantha A. Kelly, Phone: 3015941571, Rodney E. Brooks, Phone: 3014020751
- E-Mail Address
-
samantha.kelly2@nih.gov, rodney.brooks@nih.gov
(samantha.kelly2@nih.gov, rodney.brooks@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- SOURCES SOUGHT NOTICE 1. Solicitation Number: HHS-NIH-NIDA-SSSA-SS-2015-152 2. Title: Predictive Blood and Cerebrospinal Fluid Metabolomic Markers in Alzheimer's Disease 3. Classification Code: B 4. NAICS Code: 541711 5. Description: This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: There is currently a pressing need to identify predictive blood-based biomarkers of Alzheimer's disease (AD). With the repeated failures of multiple pivotal phase-III clinical trials in patients with AD, the emerging paradigm shift in Alzheimer's research calls for disease-modifying treatments to be initiated in older individuals who are in preclinical stages of disease i.e. prior to the onset of overt cognitive decline1. However, this raises the critical challenge of accurately identifying such at-risk individuals by non- invasive and inexpensive methods. If available, such methods will allow for the effective screening of large numbers of vulnerable individuals for recruitment into clinical trials and rapid testing of promising disease-modifying treatments. Currently the only modalities that are available for this purpose are assays of cerebrospinal fluid (CSF) markers of Aβ42 and tau (total and phosphorylated) and neuroimaging methods that quantify brain atrophy or fibrillar amyloid deposition. It is however unlikely that lumbar puncture (LP) will be routinely performed in large numbers of frail elderly individuals as it is associated with a degree of discomfort. Furthermore, it is impractical to perform serial LPs in an individual to monitor a biomarker response to treatment. On the other hand, neuroimaging methods are expensive and not readily available in resource-poor settings. We have therefore focused on blood-based biomarkers of AD that accurately reflect well-established endophenotypes of AD pathology such as brain atrophy, and in vivo fibrillar Aβ deposition4-8. Using mass spectrometry-based proteomic analyses in combination with multi-modal neuroimaging, these studies have revealed a robust peripheral signal from the plasma proteome that appears to be associated with AD pathology. The proposed project will use a method called quantitative targeted metabolomics for measuring the absolute concentrations of 180 metabolites in serum and post-mortem brain samples to discover predictive blood biomarkers of Alzheimer's disease (AD) and markers of resilience to AD pathology. This method is a novel approach distinct from traditional and most widely used metabolomics methodology where only relative quantification of metabolites can be determined between different samples. Relative quantification provides limited information as it only allows comparative differences (i.e. lower or higher) between samples to be determined. In order to meet the goal of the proposed study i.e. the discovery of metabolites that can predict the onset of AD before clinical symptoms, accurate and absolute quantification of metabolites is a critical requirement. This is also the ultimate goal of the proposed biomarker study i.e. the development of a blood-test for the prediction of AD that could one day be used in clinical practice settings. This can only be accomplished by the accurate estimation of absolute metabolite concentrations in serum samples. Purpose and Objectives: The contractor shall provide all resources necessary to accomplish the tasks and deliverables described in the requirements and deliverables section. The main objective of the requirement is to: 1. Perform quantitative targeted metabolomics assays on approximately 800 human serum samples from non-demented older individuals and converters to AD to measure the concentrations of small metabolites in the following classes: i) Phosphatidylcholines ii) Phosphatidylserines iii) Phosphatidylglycerols iv) Phosphatidyethanolamines v) Sphingomyelins vi) Ceramides vii) Eicosanoids and Prostaglandins viii) Oxysterols These samples will come from the Baltimore Longitudinal Study of Aging (BLSA; N=400) and the Age Gene/Environment Susceptibility-Reykjavik Study (AGES-RS; N=400). 2. Perform quantitative targeted metabolomics assays on a random sample of approximately 400 human serum samples from non-demented older individuals in the Age Gene/Environment Susceptibility-Reykjavik Study (AGES-RS; N=400) to assay the following classes of small metabolites: i) Amino Acids, Acylcarnitines, Lipids, Hexoses, Biogenic Amines & Polyamines. ii) Phosphatidylcholines iii) Phosphatidylserines iv) Phosphatidylglycerols v) Phosphatidyethanolamines vi) Sphingomyelins vii) Ceramides viii) Eicosanoids and Prostaglandins ix) Oxysterols 3. Perform quantitative targeted metabolomics assays on approximately 200 human cerebrospinal fluid (CSF) samples from participants in the BIOCARD study to assay the following classes of small metabolites: i) Amino Acids, Acylcarnitines, Lipids, Hexoses, Biogenic Amines & Polyamines ii) Phosphatidylcholines iii) Phosphatidylserines iv) Phosphatidylglycerols v) Phosphatidyethanolamines vi) Sphingomyelins vii) Ceramides viii) Eicosanoids and Prostaglandins ix) Oxysterols 4. Perform statistical analysis (accuracy, sensitivity, specificity) to identify small metabolite markers in serum and CSF that predict incident AD. 5. Return all unused specimens to their place of origin. Project requirements: Contractor Requirements • Provide shipping instructions for samples, including those for which there are two measurements/person included in the biospecimen delivery - Perform targeted quantitative metabolomics on human serum and CSF samples to measure the absolute concentrations of metabolites in the following classes: Amino Acids, Acylcarnitines, Lipids, Hexoses, Biogenic Amines & Polyamines, Phosphatidylcholines, Phosphatidylserines, Phosphatidylglycerols, Phosphatidyethanolamines, Sphingomyelins, Ceramides, Eicosanoids, Prostaglandins and Oxysterols. • Perform statistical analyses to test the utility of the above metabolites as predictive biomarkers of incident AD and as markers of resilience to AD pathology. Government Responsibilities • Provide adequate quantities of archived serum and CSF samples on dry ice to the contractor to enable the performance of the metabolomics assays detailed above. Deliverables 1. Description of Tasks and Associated Deliverables: • Excel spreadsheet with absolute serum and CSF concentrations for metabolites listed above on all serum and CSF samples provided to the contractor • WORD document detailing all the technical aspects of the experimental methodology used including coefficients of variation (CV) of the assays, specimen usage, and success/failure rate of the assay. • WORD document summarizing the clinical utility measures of the best serum and CSF metabolite markers to predict AD 2. Reporting Requirements The contractor is required to provide written progress reports every 2 months for the contract period 9/30/15 through 9/29/16. The progress report shall cover all work completed during the specified period and shall present the work to be accomplished during the subsequent period. This report shall also identify any problems that arose and a statement explaining how the problem was resolved. This report shall also identify any problems that have arisen but have not been completely resolved and provide an explanation. Travel The Government shall reserve the right to undertake one site visit during the performance period of the contract to monitor the sample storage, experimental procedures, data quality and interim statistical analyses of results. Data Rights The National Institute on Aging shall have unlimited rights to and ownership of all deliverables provided under this contract including reports, recommendations, briefings, work plans and all other deliverables. This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of "unlimited rights" is contained in Federal Acquisition Regulation (FAR) 27.401, "Definitions." FAR clause 52.227-14, "Rights in Data-General, " is hereby incorporated by reference and made a part of this contract/order. Anticipated period of performance: September 30, 2015 - September 29, 2016 Capability statement /information sought. Interested organizations must provide clear and convincing documentation of their capability of providing the item(s) specified in this notice. Interested organizations that believe they possess the ability to provide the required items must submit specific documentation of their ability to meet each of the project requirements to the Contract Specialist. Interested organizations must provide their Company Name, DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. The information submitted must be must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2" x 11" paper size, with 1" top, bottom, left and right margins, and with single or double spacing. The information submitted must be must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted electronically via email to Samantha Kelly, Contract Specialist at Samantha.kelly2@nih.gov, in MS Word format by or before the closing date of this announcement. All responses must be received by the specified due date and time in order to be considered. The response must be received on or before March 5, 2015 at 12:00PM eastern time. "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 presolicitation 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)."
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