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FBO DAILY - FEDBIZOPPS ISSUE OF APRIL 20, 2013 FBO #4165
SOLICITATION NOTICE

66 -- AutoGen FLEX STAR

Notice Date
4/18/2013
 
Notice Type
Presolicitation
 
NAICS
339112 — Surgical and Medical Instrument Manufacturing
 
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
NHLBI-CSB-(HG)-2013-132-CSP
 
Archive Date
5/17/2013
 
Point of Contact
Caitlin Palmer,
 
E-Mail Address
caitlin.palmer@nih.gov
(caitlin.palmer@nih.gov)
 
Small Business Set-Aside
Total Small Business
 
Description
INTRODUCTION This is a pre-solicitation / notice of intent synopsis for a sole source noncompetitive (including brand-name) award to AutoGen, Inc. for the AutoGen FLEX STAR. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), on behalf of the The National Human Genome Research Institute (NHGRI) intends to negotiate and award a firm-fixed price contract on a sole source noncompetitive basis for the AutoGen FLEX STAR to AutoGen, Inc., 84 October Hill Road, Holliston, MA 01746. BACKGROUND The National Human Genome Research Institute (NHGRI), Undiagnosed Disease Program (UDP) is a program designed to address the needs of persons with debilitating medical conditions for which no diagnosis has been found despite an extensive workup. The goals of the UDP include finding accurate diagnoses and discovering new diseases that provide insight into human physiology and genetics. In order to perform these goals, Blood samples from all admitted Undiagnosed Diseases patients and family members will be obtained for DNA isolation to perform necessary biological laboratory experiments to determine the mechanisms of the patients' diseases. Currently, isolation of blood is done manually and in common spaces shared with other laboratory workers. The proposed acquisition, for the AutoGen FLEX STAR, will be used to extract DNA from human blood samples. The addition of the AutoGen Flex Star to the Undiagnosed Diseases Program Laboratory will greatly reduce exposure of workers to human blood borne pathogens, and will also ensure that the DNA is reproducibly isolated- according to a standardized protocol. PERIOD OF PERFORMANCE The delivery period for the AutoGen FLEX STAR is 8-12 weeks after receipt of the award. The proposed acquisition is a new requirement. PROJECT DESCRIPTION Blood samples from all admitted Undiagnosed Diseases patients and family members will be obtained for DNA isolation to perform necessary biological laboratory experiments to determine the mechanism of the patient's disease. The DNA isolated from patient and family member's blood will be used to perform genetic studies such as; combined SNP and WES analysis using family members and filtering programs developed in house, sequencing data verification using PCR, and laboratory experiments pertinent to the unique patient's disease. UDP laboratory experiments require the use of very clean, concentrated, and reliable DNA derived from the patients in order to perform research experiments to discern the genetic and molecular basis of the unique disease of the patient. The contractor shall supply all labor, materials, facilities, equipment, and supplies to perform or supply the following: A quantity of one AutoGen FLEX STAR. The AutoGen Flex Star is an instrument that offers fully automated genomic DNA extraction and isolation from up to 5.0 mls of whole blood which can process up to 30 samples of DNA per batch, and contains a required internal bar code scanner for sample tracking, and delivers high yields of high-quality genomic DNA. The UDP laboratory experiments require the use of very clean, concentrated, and reliable DNA derived from the patients in order to perform research experiments to discern the genetic and molecular basis of the unique disease of the patient. AutoGen FLEX STAR Specifications: • System shall be fully automated for the isolation of genomic DNA. • System must have available protocols for the isolation of genomic DNA from whole blood, buffy coat, tissue, cultured cells, buccal swabs and Oragene saliva. • System shall have software for sample tracking and error reporting with a bar code reader. • System shall have interface to a PC workstation for data management. • System shall have the capability to process, unattended, up to 30 samples, in a single uninterrupted run and up to 90 samples per day. • System shall process 0.5-5.0ml starting volume of whole blood samples either fresh or frozen. • System shall utilize the Qiagen FlexiGene chemistry for DNA extraction from whole blood and buffy coats. • System shall not require a filter or column or magnetic beads for the recovery of nucleic acids and shall not require the use of a vacuum system. • System shall have the ability to run unattended. • System shall be menu driven and microprocessor controlled. • System will provide high quality DNA for direct use in: Fluorescent DNA Sequencing (DNA), PCR (DNA), and Southern Blotting (DNA). • System shall be a floor-standing instrument for ease of movement and occupy floor space no greater than 100 cm (W) x 75 cm (D). • System shall offer pre-programmed protocols. • User shall have the ability to edit protocol parameters. • System shall have the ability to transfer liquids without the use of pipettes or probes to prevent cross contamination. • System shall include a HEPA-Filter system to prevent the possibility of aerosol contamination. • System will have an easy recovery of preps in the event of any power loss with a restart function (no need to complete preps manually). JUSTIFICATION The sole-single (including brand-name) justification is based upon the fact that: AutoGen is the sole provider of the FLEX STAR system, a fully automated genomic DNA isolation and extraction machine from up to 30 samples per run. The system is capable of producing high quality genomic DNA from 0.5 - 5.0 mls of fresh or frozen whole blood, tissue, cells and Oragene-DNA collected saliva samples by using Qiagen's proven FlexiGene chemistry. The FlexiGene chemistry employs an initial process that pellets the white cell nuclei and mitochondria while simultaneously lysing the red cells. During the following step, it denatures and eliminates the proteins and cellular material utilizing a protease enzyme. This method of isolation and extraction delivers a superior quality DNA with a spectrophotometer 260/280 reading of 1.7 to 1.9, which indicates pure DNA, free from contaminating proteins and RNA. The AutoGen Flex Star is the only DNA isolation and extraction machine available that contains a sample tracking and reporting package that utilizes barcode identification of samples. The internal bar code identifies and tracks each sample through the entire isolation process. The AutoGen Flex Star software is unique in its ability to provide a report that documents the position of each sample and all conditions and parameters of each run. An interface to LIMS system allows for downloading these reports to the LIMS database that is currently under development in the UDP laboratory. The AutoGen Flex Star system for DNA Extraction from large volume whole blood is offered exclusively in North America and Europe by AutoGen, Inc. The system and its associated reagents and consumables are proprietary to AutoGen and are not available through any other vendors in the above mentioned territories. REGULATORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 253(c) as set forth in FAR Part 6.302-1(b), only one responsible source and no other supplies or services will satisfy agency requirements. ADDITIONAL INFORMATION The North American Industry Classification Code (NAICS) is 339112, Sugical and Medical Instrument Manufacturing, and the Size Standard 500 Employees. This pre-solicitation / notice of intent is not a request for competitive proposals. This announcement constitutes the only notice; proposals are not being requested and a written solicitation will not be issued. The determination by the Government to award a contract on a sole source noncompetitive basis for the AutoGen FLEX STAR to AutoGen, Inc., 84 October Hill Road, Holliston, MA 01746 is based upon the responses to the sources sought synopsis published in the FedBizOpps on April 11, 2013, under synopsis number NHLBI-CSB-(HG)-2013-130-CSP, titled AutoGen FLEX STAR. Any information received as a result of this pre-solicitation / notice of intent will be considered solely for the purpose of determining whether to conduct any future competitive procurements. Interested parties may identify their interest and capability for any future competitive procurement by responding to this notice in writing, no later than May 02, 2013 9:30am, EST. Responses to this notice shall contain sufficient documentation to establish the interested parties' bona-fide capabilities for fulfilling the requirement. All responses must reference this pre-solicitation / notice of intent number NHLBI-CSB-(HG)-2013-132-CSP and may be submitted electronically to the Contracting Specialist, Caitlin Palmer at caitlin.palmer@nih.gov.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-(HG)-2013-132-CSP /listing.html)
 
Place of Performance
Address: NIH, Bethesda, Maryland, 20892, United States
Zip Code: 20892
 
Record
SN03040130-W 20130420/130418234523-6d52b009c43abb5df3b673a9881f9cdc (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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