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FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 08, 2013 FBO #4122
SOLICITATION NOTICE

65 -- Intent to Sole Source to LipoScience, Inc. For the Purchase of the Vantera Clinical Analyzer, with Nuclear Magnetic Residence (NMR) Technology

Notice Date

3/6/2013
 

Notice Type

Presolicitation
 

NAICS

423450 — Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
 

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-HL-2013-100-RRJ
 

Archive Date

3/21/2013
 

Point of Contact

Robin Jeffries, Phone: 3014350376
 

E-Mail Address

robin.jeffries@nih.gov
(robin.jeffries@nih.gov)
 

Small Business Set-Aside

N/A
 

Description

This is a Pre-Solicitation/Notice of Intent Synopsis for a sole source noncompetitive award to LipoScience, Inc., Raleigh, NC for the Vantera Clinical Analyzer, with NMR Technology. The National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), on behalf Lipoprotein Metabolism and the Inflammation and Cardiometabolic Disease sections of the Cardiovascular Pulmonary Branch (CPB) intends to negotiate and award a purchase order on a sole source noncompetitive basis for the LipoScience, Inc.'s Vantera Clinical Analyzer, with NMR Technology to LipoScience, Inc. for the measurement of lipoprotein particle numbers and lipoprotein subfractions by Nuclear Magnetic Residence (NMR). The NMR analyzer will be used for two main applications. The first application will be the measurement of lipoprotein particle numbers and subfractions on human and mouse serum samples. It is anticipated that it will be used for the measurement of over 10,000 samples a year and therefore will have to be fully automated and high-throughput. It should have both the hardware, such as an automated sample rack delivery system and the software for the fully automated reporting of results. The second application will be the measurement of lipoprotein particle number and lipoprotein subfractions after the in vitro modification of samples, such as treatment to deplete or enrich for the various components of lipoproteins. This will involve the analysis of the NMR spectra at different at different chemical shifts that what may be used for lipoprotein analysis, therefore, the NMR spectra should contain software for the flexible development of user defined parameters for NMR analysis. The equipment will provide the necessary data on the interaction of lipoprotein particle number and subfractions to help design better diagnostic tests and to investigate new lipid modifying therapies, which is a major objective of the Cardiovascular Pulmonary Branch. The following general specifications are required for the clinical diagnostic NMR analyzer: • 200 sample tube capacity for front end sample rack system • 150ul sample size limit • sample throughput of at least 35 samples/hr • Sample diluted online with 150ul of diluent and internal standard • Positive sample ID through use of barcodes • Automated cleaning of system between samples and during daily maintenance • Automated magnetic field alignment and verification • 400Mhz magnet • Automated spectra analysis, result calculation, pre and post analytical QC to verify system function and sample integrity • Training The basis for the sole source determination is based upon the fact that: LipoScience, Inc. is the sole provider of the Vantera Clinical Analyzer, with NMR Technology. The LipoScience's Vantera Clinical Analyzer is a unique NMR diagnostic device that is currently the only commercially available NMR system that automates the processing and analysis of plasma and serum based samples. The Vantera Clinical Analyzer combines nuclear magnetic resonance (NMR) spectroscopic detection and proprietary signal processing algorithms to identify and quantify concentrations of lipoproteins and, potentially, small molecule metabolites. Other NMR systems that are currently available for research purposes do not include the automated features and hardware (sample rack) of the Vantera for the high throughput processing of clinical samples. The algorithm on the Vantera analyzer for converting the NMR spectra into lipoprotein particle numbers and subfractions is also unique and are not currently commercially developed would likely take several years to develop and validate on a research grade NMR analyzer. Additionally there is unique/proprietary tool kits/software available on the Vantera to further interrogate the digitized NMR sample spectrum for quantification of unknown metabolites and their disease correlation. The LipoScience Vantera Clinical Analyzer, with NMR Technology, received FDA clearance and will be placed with national and regional clinical laboratories. The Vantera Clinical Analyzer combines nuclear magnetic resonance (NMR) spectroscopic detection and proprietary signal processing algorithms to identify and quantify concentrations of lipoproteins and, potentially, small molecule metabolites. LipoProfile test is LipoScience's proprietary diagnostic test that measures the number of low density lipoprotein particles (LDL-P) in a blood sample and provides physicians and their patients with actionable information to personalize management of risk for heart disease. This acquisition is conducted under the authority of 41 U.S.C. 253(c) as set forth under FAR Part 13.106-1 (b) (1), Soliciting from a single source not exceeding the simplified acquisition threshold, and is exempt from the requirements of FAR Part 6, Competition Requirements. The North American Industry Classification System (NAICS) code 423450 - Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers with a size standard of 100 employees. This Pre-Solicitation/Notice of Intent is not a request for competitive proposals. This announcement constitutes the only notice; proposals are not being request 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 preventative maintenance services for the BD Biosciences Flow Cytometer Analyzer to BD Biosciences, San Jose, CA is solely within the discretion of the Government. 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 procurement. Interested parties may identify their interest and capability for any future competitive procurement by responding to this notice in writing, no later than March 20, 2013 at 11:59 p.m. 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-HL-2013-100-RRJ and may be submitted electronically to Robin Jeffries, Contracting Officer at robin.jeffries@nih.gov or by mail to the National Heart, Lung, and Blood Institute, Office of Management, 6701 Rockledge Drive, Suite 6122, Bethesda, MD 20892-7902, Attention: Robin Jeffries, Contracting Officer.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-HL-2013-100-RRJ/listing.html)
 

Place of Performance

Address: NIH/NHLBI/OM/COAC Services Branch, 6701 Rockledge Drive, Suite 6122, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN03005096-W 20130308/130306234204-748a53534b92635444a31f5a029d46cd (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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