SOLICITATION NOTICE
B -- Candidate Biomarkers for Human Neuro-Inflammatory Diseases - Combined Synopsis/Solicitation
- Notice Date
- 1/21/2015
- 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-CSS-15-99
- Archive Date
- 2/20/2015
- Point of Contact
- Farrin Stanton,
- E-Mail Address
-
farrin.stanton@nih.gov
(farrin.stanton@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Rights in Data Security Clauses Invoicing instructions Statement of Work solicitation Title: Candidate Biomarkers for Human Neuro-Inflammatory Diseases (i) This is a combined synopsis/solicitation for commercial items 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. (ii) The solicitation number is HHS-NIH-NIDA-(SSSA)-CSS-15-99 and the solicitation is issued as a request for proposal (RFP). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) FAR Part 12—Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-73, dated December 26, 2014. (iv) A notice regarding any set-aside restrictions, the associated NAICS code 541711 – RESEARCH AND DEVELOPMENT and the small business size standard is 500 employees. (v) Development of combinatorial process-specific cerebrospinal fluid biomarkers as novel outcomes for therapeutic development in neuro-inflammatory diseases. (vi) Background The National Institute of Neurological Stroke and Disorders (NINDS) Neuroimmunological Diseases Unit (NDU) has recently concluded a pilot study using MultiPlex proteomics platform called SomaScane, from US company SomaLogic. This platform allows highly sensitive and reproducible quantification of up to 1129 proteins in human CSF sample. It also requires minimal amount of CSF (<100ul). The amount of CSF that can be obtained from patients is rather limited; therefore having a methodology that enables measuring of large number of markers in the smallest volume possible is essential to the study. SomaLogic Offers a methodology that makes this possible. To confirm all statistically-significant differences between diagnostic categories identified in the pilot part of the project, NDU is currently in the process of validation of all CSF candidate biomarkers in an independent cohort of 240 untreated subjects using the SomaScan platform. In the next stage, NDU will use these CSF biomarkers as outcome measure in therapeutic development for MS. Description The general purpose of this project is to identify new candidate biomarkers for human neuro-inflammatory diseases. Scope of Work The specific purpose of this particular part of the project is to perform highly sensitive (i.e. femtomolar 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 either human biological fluids (cerebrospinal fluid, serum) or in cultured media of primary human cell lines. The contractor shall deliver the annotated “raw measurements” of all tested analytes in provided samples (Excel sheet or similar platform), which will represent relative, (but generally linear) representations of inter-personal differences in the analyte concentrations. 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. 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) (vii) The period of performance is a 12 months, with 4 subsequent 1-year option periods (viii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition. (ix) The provision at FAR clause 52.212-2, Evaluation – Commercial Items, applies to this acquisition. (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. Technical and past performance when combined is more important when compared to price.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-CSS-15-99/listing.html)
- Place of Performance
- Address: 6100 Executive Blvd., rockville, Maryland, United States
- Record
- SN03621251-W 20150123/150121235202-6e953d66f2df74432d1930eaf7e723f9 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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