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FBO DAILY - FEDBIZOPPS ISSUE OF APRIL 03, 2014 FBO #4513
SOURCES SOUGHT

66 -- Automated System for Translational Research and Reagents

Notice Date
4/1/2014
 
Notice Type
Sources Sought
 
NAICS
339999 — All Other Miscellaneous Manufacturing
 
Contracting Office
Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
 
ZIP Code
20857-0001
 
Solicitation Number
FDA-SS14-1130640
 
Archive Date
4/23/2014
 
Point of Contact
Christopher R. McGucken, Phone: 3018277161
 
E-Mail Address
christopher.mcgucken@fda.hhs.gov
(christopher.mcgucken@fda.hhs.gov)
 
Small Business Set-Aside
N/A
 
Description
TITLE: Automated System for Translational Research and Reagents OPDIV: FDA, Center for Drug Evaluation and Research This is a SOURCES SOUGHT NOTICE to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) in accordance with FAR 7.104(d). The potential small business will need to demonstrate the capability to perform all facets of the work described below. The sole intent of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes. This is not an invitation for bid, request for proposal, or other solicitation, and in no way obligates the Food and Drug Administration (FDA) to award a contract. BACKGROUND The Division of Therapeutic Proteins conducts research on assessing the quality and safety of existing drug products as well as on discovering biomarkers and targets needed to develop and/or ameliorate effective therapeutic strategies. The ongoing research activities in the Laboratory of Immunology are focused on identifying biomarkers and potential targets for infections and autoimmune disorders to modulate the host immune response and facilitate the clearance of the disease. To this end, the Laboratory of Immunology conducts a variety of assays which require the simultaneously and highly sensitive detection, measurement, and interactions with proteins of hundreds different nucleic acids with immunoregulatory functions such as messenger RNAs (mRNA), microRNA (miRNA), long non-coding RNAs (lncRNA), and DNA in a large set of samples. This acquisition calls for reagents and instruments allowing a digital gene expression analysis that is uniquely suited to the research of our laboratory. CONTRACTOR REQUIREMENTS Respondent Contractors shall be able to provide: One instrument and accompanying reagents that shall have the following salient characteristics, applications and features: The features of the instruments shall include: An i nterface that walks the user through each step of the set up process using a stage layout map for the fully automated processing of samples for the digital gene expression analysis. High compatibility with reagents and sample types mentioned below. A specialized customer service for the installation and maintenance of equipment, as well as for the teaching of data processing. The applications shall include: Gene expression analysis f or the analysis of the expression levels of at least 500 genes simultaneously in a single sample. Single-cell expression ana lysis for identifying cell-to-cell differences (based on single-cell specific gene signature) within a population of cells. The single-cell expression ana lysis must allow the analysis of at least 500 genes simultaneously in a single-cell sample. miRNA expression analysis for the expression profiling of hundreds of mi RNAs in a single reaction. The miRNA expression analysis must acc urately distinguish between highly similar miRNAs at a single-base resolution. miRGE analysis for the simultaneous profiling of both miRNAs and mRNA s in a single reaction from a single sample. Copy number variation analysis to multiplex with at least500 target regions in a single reaction from a single sample. This analysis must provide high accuracy for multiallelic copy number variations. IncRNA expression analysis for validation of lncRNA discoveries and other studies requiring a rapid, cost-ef f ective method of screening hundreds of lncRNAs across large sample sets. The assay must allow the selection of at least 500 lncRNAs for analysis in a single multiplexed reaction. This analysis must allow the combining of probes for lncRNAs and mRNAs in the same reaction to enable simultaneous analysis of both classes of RNA in the same sample. ChIP-string expression analysis for measuring dsDNA fragments that have been enriched via chromatin immunoprecipitation. This analysis must allow the quantification as little as 5 ng of enriched chromatin-immunoprecipitated DNA directly with no amplification. The features of the reagents shall include: T arget-specific probes allowing the detection and counting of hundreds different types of nucleic acids in a single reaction. Each run should be able to test at least 12 samples in parallel. Capacity of measuring simultaneously different types of nucleic acids directly in tissue, cells, and blood lysates as well as in formalin-fixed paraffin-embedded extracts without the need of intermediate steps of purification and amplification that might introduce bias into the results, thus allowing to save time and precious reagents. No enzymes required to perform assay. High levels of precision and sensitivity (>1 copy of nucleic acid per cell). Master kit reagents and consumables including sample-containing glass cartridges shall be compatible with the digital gene expression analysis. Capability statements must demonstrate the minimum requirements outlined above. Please address each in the order listed above and include any product sheets for the proposed system. Please provide the follow Business information: DUNS Number Company Name Company Address. Company Point of Contact, phone number and email address Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); Current GSA Schedules appropriate to this Sources Sought Current Government Wide Agency Contracts (GWACs) Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email or regular mail to the point of contact listed below. Responses shall be limited to 10 pages. Responses must be received not later 4:00 PM EST, April 8th, 2014. Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to: Christopher.McGucken@fda.hhs.gov
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS14-1130640/listing.html)
 
Record
SN03325560-W 20140403/140401234645-4c52f8c74de3a8f1e2971ff60e955127 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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