SOLICITATION NOTICE
B -- Candidate Biomarkers for Human Neuro-Inflammatory Diseases - Combined Solicitation-Synopsis
- Notice Date
- 5/29/2014
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-(SSSA)-14--223
- Archive Date
- 6/28/2014
- Point of Contact
- Brian Lind, Phone: 3014021635
- E-Mail Address
-
lindbj@nida.nih.gov
(lindbj@nida.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Attachment number Four - Rights in Data Attachment Number Three - Security Clauses Attachment Number Two - Invoicing Instructions Attachment Number One - Statement of Work Combined Solicitation-Synopsis THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The Solicitation Number for this acquisition is HHS-NIH-NIDA-(SSSA)-14- 223 and is being issued as a Request for Proposal (RFP). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-73 effective April 29, 2014. This acquisition is unrestricted. The North American Industry Classification System (NAICS) Code for this procurement is 541711 and the Small Business Size Standard is 500 employees; Research and Development Bio-Technology. STATEMENT OF OBJECTIVES To procure services to identify new candidate biomarkers for human neuro-inflammatory diseases. STATEMENT OF WORK The specific purpose of this particular part of the project is to perform highly sensitive (i.e. fentomolar or low picomolar detection range) and reproducible (i.e. known assay performance with CVs <15%) quantitative analysis of largest possible number of proteins that originate either from the central nervous system (CNS) tissue or from infiltrating immune cells in 85 samples of cerebrospinal fluid derived from 5 diagnostic categories in order to identify new candidate biomarkers. The contractor will be provided with 85 human CSF samples pre-selected by NDU personnel. For some of the analytes that are present in sufficiently high concentrations in the human CSF to be detected by immunoassays (i.e. Fetuin A, NCAM/CD56, OMGP, contactin 2, IL-12p40, CXCL13, IL-8, IL-6, IL-6Ra, DJ-1, cytochrome C, HGF, BDNF, Sirtuin 2) the quality of the new multiplex assay will be compared to state of the art single-plex immunoassay results performed at NDU laboratory. Thus, it is highly desirable that the selected multiplex assay has at least 3 analytes that overlap with this list of high-concentration analytes. The contractor is expected to evaluate assay performance for the provided 85 CSF samples with assay performance in previous CSF samples measured by the same technology and apply any internal normalization(s) that may be necessary to adjust for global assay performance. The contractor is also expected to provide general QC data such as assay performance, CVs etc. The technical requirements for the assay used to analyze CSF biomarkers are: • Sensitivity: Detection limit in fM or low pM (0.1-0.01 pM) range, as majority of interesting protein biomarkers in the CSF are present in such low concentrations • Specificity: Methodology that has low cross-recognition of other analytes • Reproducibility: Methodology that has demonstrated low inter-assay variability (ideally <10%) • Linear range: Because of the great intra-individual heterogeneity, ideal assay will have very broad linear range (>6 logs), so that measurements are reliable in individuals with extremely low or extremely high analyte concentrations • Sample requirements: Because the CSF samples are very precious and utilized for multiple projects/assays, the large sample requirement may also limit our ability to utilize a contractor. Generally speaking, sample sizes below 1ml are acceptable and below 0.5ml are ideal. • Number and type of proteins tested: In the discovery (pilot) part of the project we would like to test the largest possible number of analytes (ideally >1000). It is imperative that proteins secreted by immune cells are included in the analytes. Similarly, it is important that proteins secreted by CNS resident cells, such as neurons, oligodendrocytes and astrocytes are also broadly represented in the panel of tested analytes. • Proven record of detectability of proteins in human CSF samples: Although one might be able to estimate the proportion of analytes that may be detectable in human CSF based on the lower level of detection limit of the assay, the available data that demonstrate ability to detect substantial portion of assayed analytes in the human CSF (e.g. in healthy subjects or subjects with neurological diseases) would be a definite plus in deciding the adequacy of new multiplex technology. Please refer to the attached Statement of Work for complete details and specifications. The following attachments are provided to assist you in preparing your proposal responding to this solicitation. Attachment No. 1: Statement of Work Attachment No. 2: Invoice Instructions Attachment No. 3: Security Clauses Attachment No. 4: FAR 52.227-14 - Rights in Data-General, (DEC 2007) Please refer to the attached combined solicitation\synopsis for complete details, applicable FAR clauses and proposal submission instructions.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-(SSSA)-14--223/listing.html)
- Place of Performance
- Address: Assays will take place at the contractors facilities., United States
- Record
- SN03379321-W 20140531/140529235050-f3fb70db7b556ea7a05846d47e695cea (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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