SPECIAL NOTICE
66 -- Notice of Intent to Sole Source to EMD Millipore for the Luminex MAGPIX® System with xPONENT™ 4.2 MAGPIX® Analyzer along with the EMD Millipore Milliplex 5.1 Analyst Software and a Milliplex Kit to include installation and training
- Notice Date
- 8/29/2016
- Notice Type
- Special Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-16-T-0449
- Archive Date
- 9/27/2016
- Point of Contact
- Lisa D. Walters, Phone: 3016193451
- E-Mail Address
-
lisa.d.walters13.civ@mail.mil
(lisa.d.walters13.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- The U.S. Army Medical Research Acquisition Activity (USAMRAA) intends to award a sole-source contract in the amount of $32,288.00 to EMD Millipore for the purchase of the Luminex MAGPIX® System with xPONENT TM 4.2 MAGPIX® Analyzer along with the EMD Millipore Milliplex 5.1 Analyst Software and a Milliplex Kit; to be used for research studies in the Department of Subunit Enteric Vaccines & Immunology, Bacterial Diseases Branch, at the Walter Reed Army Institute of Research (WRAIR). The Department of Subunit Enteric Vaccines & Immunology, Bacterial Diseases Branch, WRAIR, has developed the Shigella Invaplex vaccine, a subunit vaccine that contains the Shigella invasin proteins IpaB and IpaC, as well as the O-antigen or lipopolysaccharide (LPS). Initial experiments and human clinical trials utilized Invaplex produced from the virulent organism. A 2nd generation vaccine, termed Artificial Invaplex (InvaplexAR), has been constructed using recombinantly produced IpaB and IpaC and purified LPS, resulting in a more well-defined and potent product. A crucial piece in the testing of new vaccine candidates is to assess the immune response in pre-clinical models. Immune parameters can be measured by bead based systems. These systems increase the throughput of our assays and allow a reduction in the amount of sample required to assess multiple immune parameters. Standard Operating Procedures (SOPs) mandate the use of a system that is compatible with Luminex microspheres and Luminex analysis software. The Luminex MAGPIX® System with xPONENT TM 4.2 MAGPIX® Analyzer has been identified as the only multiplexed bead based analysis system that will satisfy the requirements of the Department of Subunit Enteric Vaccines & Immunology. The products are: 1. MAGPIX® System with xPONENT TM 4.2 MAGPIX® Analyzer 1 Each 2. Milliplex Analyst 5.1 Software with 1 Seat License 1 Each 3. MAGPIX® Installation and Training 1 Each 4. Any Milliplex Kit -- to be decided at time of purchase 1 Each The MAGPIX® System with xPONENT TM 4.2 MAGPIX® Analyzer is the only multiplexed bead based analysis system that is compatible with Luminex microspheres and analysis software. The research paper titled: Multiplexed Immunoassay to Assess Shigella-Specific Antibody Responses and published in the Journal of Immunological Methods in 2013, was the culmination of the development of a multiplexed assay that was developed using the Luminex MAGPIX® System with xPONENT TM 4.2 MAGPIX® Analyzer which "simultaneously measures antibodies directed to six key Shigella antigens". This breakthrough research resulted in the assay being "sensitive, specific, and robust, using less dilution as compared to an ELISA and taking approximately as much time but producing six times the result". In addition, the assay can be amended easily to detect mouse, guinea pig, monkey and human antibodies. The purchase of an additional Luminex MAGPIX® System is critical to replicating and providing additional validation of the study, as well as moving forward in WRAIR's research with adding Shigella LPS and protein antigens and establishing optimal storage and assay conditions. The development of a multiplexed assay in the above study was made possible utilizing the Milliplex Analyst Software and Milliplex Kits which are software and data analysis kits that are proprietary to EMD Millipore and which are compatible with the Luminex microspheres and analysis software. The multiplex assay was optimized with so many parameters in conjunction with the Luminex System, that in order to switch to using a different type of bead based system (which would include the use of different microspheres, software and data analysis kits); WRAIR would have to start over at square one after years of developed research and be unable to move forward with their current research, of which the Luminex MAGPIX® System with Milliplex Analyst Software and Milliplex Kits have already been incorporated as part of their Standard Operating Procedures. Many already established research protocols would be unable to be replicated and expanded as the research has been fine-tuned using this particular MAGPIX® System with xPONENT TM 4.2 MAGPIX® Analyzer for magnetic beads based on LEDs, CCD Camera and image analysis, in conjunction with the Milliplex Analyst Software and various Milliplex Kits designed to work with this particular bead-based system. Luminex Corporation is the only company who has the ability to provide the MAGPIX® System with xPONENT TM 4.2 MAGPIX® Analyzer; as the bead based system is proprietary to Luminex and manufactured in Texas, U.S.A., therefore; they are the only source capable of meeting WRAIR requirements. The government does not intend to post a solicitation for this requirement nor is this a request for a solicitation or competitive proposals. However, if a company believes it could meet or exceed all the needs of the Walter Reed Army Institute of Research for this requirement, it may submit documentation as such (i.e. a proposal, quote or capabilities statement) and any reasonable offer shall be considered by this agency. All responses to this notice must clearly indicate to the Government that pursuing competition in future procurements would be advantageous. If qualified sources are not presented to the Government by a response to this notice, then a contract shall be awarded in accordance with a Sole Source Justification (SSJ) in accordance with FAR subparts 13.106 using Simplified Acquisition Procedures (SAP); pursuant to 41 U.S.C. 1901; simplified acquisition procedures, as implemented by FAR 13.106-1(b)(1)(i), Soliciting from a single source. No telephone inquiries will be accepted. This notice of intent to sole source does not obligate the Government to award a contract or otherwise pay for the information provided in the response. The Government reserves the right not to compete this requirement. Any qualified offerors must submit their capabilities statement in writing no later than Monday 12 September 2016 by 9:00AM Eastern Standard Time to USAMRAA, Attn: Lisa Walters, Lisa.D.Walters13.civ@mail.mil. Any responses received after this date and time will not be considered. Any response documentation received shall become the property of the Government.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-16-T-0449/listing.html)
- Place of Performance
- Address: WRAIR, 503 Robert Grant Avenue, Silver Spring, Maryland, 20910, United States
- Zip Code: 20910
- Zip Code: 20910
- Record
- SN04245004-W 20160831/160829235026-b0bdc58b2faf3ff42dedcbf4629a1d77 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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