SOLICITATION NOTICE
66 -- ProFlu-ST Control Kits.
- Notice Date
- 11/2/2009
- Notice Type
- Presolicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Veterans Affairs;Rocky Mountain Network;VISN 19 Contracting;4100 E. Mississippi Avenue, Suite 1110;Glendale CO 80246
- ZIP Code
- 80246
- Solicitation Number
- VA-259-10-RQ-0016
- Response Due
- 11/9/2009
- Archive Date
- 1/8/2010
- Point of Contact
- Susan CorbeilContracting Officer
- E-Mail Address
-
CO email address
(susan.corbeil@va.gov)
- Small Business Set-Aside
- N/A
- Description
- Under the Authority of 41 U.S.C. 253(c)(1), and FAR 6.302-1, the VISN 19 Rocky Mountain Consolidated Contracting Center, Denver, CO, proposes to enter into a non-competitive commercial items contract with Prodesse, Inc. (Gen-Probe) for ProFlu-ST Detection and Control kits. ProFlu-ST received an FDA Emergency Use Authorization on October 27, 2009. Contractor's unique characteristics include: an easy-to-use real-time multiplex Real-Time RT-PCR for Influenza A that discriminates: - seasonal Influenza A/H1 - seasonal Influenza A/H3 - 2009 H1N1 Influenza ProFlu-ST is used for the detection of 2009 H1N1 Influenza Virus aided by an algorithm that relies on seasonal influenza A/H1 and A/H3 results. "This test has not been FDA cleared or approved; "This test has been authorized by FDA under an Emergency Use Authorization, and only for the diagnosis of 2009 H1N1 influenza virus infection in patients who have already been diagnosed with influenza A by currently available FDA-cleared devices; "This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1); and "The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed. "CLIA High Complexity Laboratories will test a patient sample using the Prodesse ProFlu - ST Assay only when the patient sample has already been tested positive for Influenza A by a currently available FDA-cleared nucleic acid amplification technologies (NAAT)-based Influenza A device with high performance[1]. [1] An FDA-cleared NAAT-based Influenza A device with high performance is an FDA cleared NAAT-based IVD device detecting Influenza A that demonstrates sensitivity (compared to viral culture) of at least 95% and specificity of at least 92% with a lower bound of 95% (two-sided) confidence interval exceeding 90% and that does not require culture confirmation for negative results. Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals. However, all proposals received within the due date for receipt of proposals will be considered by the Government. A Determination by the Government not to compete with this proposed contract based upon 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VARMCCC/VARMCCC/VA-259-10-RQ-0016/listing.html)
- Place of Performance
- Address: Department of Veterans Affairs;Eastern Colorado Healthcare System;1055 Clermont St;Denver CO
- Zip Code: 80220-3808
- Zip Code: 80220-3808
- Record
- SN01996192-W 20091104/091102234734-47204225992196df56b5e2fd477a6e37 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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