SOLICITATION NOTICE
66 -- FLUOGENE SYSTEM MOLECULAR TESTING PLATFORM FOR TRANSFUSION MEDICINE
- Notice Date
- 8/10/2017
- Notice Type
- Presolicitation
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- 17-012745
- Archive Date
- 9/9/2017
- Point of Contact
- Malinda Dehner, Phone: 301-594-6320, Barbara Taylor, Phone: 301-594-5915
- E-Mail Address
-
dehnerm@cc.nih.gov, Barbara_Taylor@nih.gov
(dehnerm@cc.nih.gov, Barbara_Taylor@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. The National Institute of Health, Clinical Center (CC) intends to award a fixed price purchase order to Hemo Bioscience Inc. Morrisville, NC, 27560-6364 on a sole source basis to procure the FluoGene system, a molecular testing platform that will be able to define the exact molecular sequence of patients Red Blood Cells (RBC) antigens, and then match that sequence with the exact sequence of NIH donors' RBC antigens. The FluoGene system is a unique method for molecular defining Human Leukocyte Antigens (HLA), Red Blood Cells (RBC), and Human Platelet Antigen (HPA) typing combining all advantages of the Sequence Specific Primer (SSP)-Polymerase Chain Reaction (PCR) with the speed of endpoint fluorescence detection. The analysis is based on a specifically modified TaqMan® probe system detected by the FluoVista Analyser. All FluoGene kits are CE (European Union) marked in accordance with the IVD Directive 98/79/EC and manufactured and tested under a quality system in compliance with DIN EN ISO 13485. The only known US distributor is Hemo Bioscience Inc. Unlike other molecular testing platforms, the FluoGene system offers the following advantages: • PCR-SSP method without gel electrophoresis within 90 minutes • no hybridization and washing steps • display of typing results immediately after the post-read • no risk of post-PCR contaminations • low DNA consumption • user-friendly software solution, fully-automated calculation of results • multiuse - same system for HLA- and RBC- antigens The FluoGene system will be used to improve the efficacy and safety of red blood cell transfusions for the patients of the Clinical Center coming to the NIH under protocol. Many of these patients, having been multiply transfused, are difficult to match with compatible RBCs, and the Fluogene system will be able to define the exact molecular sequence of patients' RBC antigens, and then match that sequence with the exact sequence of NIH donors' RBC antigens. In addition, it will also be able to provide backup for the current molecular process now in use for defining Human Leukocyte antigens, used for matching bone marrow transplants and for matching patients with compatible platelets for transfusion. This is the only known system available in the US which can provide the same analysis capability with a user-friendly and mostly hands-free operation. This acquisition is being conducted under the authority of the FAR Subpart 13.106-1(b)(i), Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available. Interested concerns capable of providing the same or similar products or services as described in this notice may submit a capability statement outlining their capabilities. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Each response should include the following Business Information: a. DUNS. b. Company Name, address, POC, Phone and Email address c. Current GSA Schedules or NAICS codes appropriate to this Award. d. Type of Company (i.e., small business, 8(a), woman owned, hubZone, veteran owned, etc.) as validated in System For Award Management (SAM). All offerors must register on the SAM located at http://www.sam.gov/portal/SAM/#1 e. Capability Statement Comments to this announcement may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Malinda Dehner, Contract Specialist, dehnerm@cc.nih.gov by the due date and time marked in this notice.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/17-012745 /listing.html)
- Place of Performance
- Address: 9000 Rockville Pike, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04622036-W 20170812/170810231600-4b37dacf30726adc8edcd1e6681b3721 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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