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65--Request for Information/Notice of Intent to Sole Source to Abbott Laboratories.

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ALB156131Federal

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The U.S. Army Medical Acquisition Activity (USAMRAA) plans to award a sole source contract to Abbott Laboratories for the supply of Abbott ViroSeq HIV-1 Genotyping Reagent v2.0 and HIV-1 Integrase Genotype Reagent v2.0 test kits and consumables. These kits are essential for HIV-1 Resistance Genotype testing conducted by the WRAIR HIV Diagnostics and Reference Laboratory (HDRL), which supports HIV screening, confirmatory testing, and molecular testing for the U.S. Army, its beneficiaries, and other military services. The Abbott ViroSeq assay is the only FDA-cleared test for monitoring patients on HIV drug therapy, while the Integrase Genotype kit is the only GMP-manufactured test available to detect resistance mutations to integrase inhibitors. The contract will be awarded without competition under statutory authority allowing sole source procurements when only one responsible source exists that can meet agency requirements. USAMRAA intends to issue the request for quotations (RFQ) on this sole source basis after a 15-day notice period from the synopsis posting date, during which interested parties may submit information regarding their capabilities to compete. This contract falls under NAICS code 325413 with a size standard of 500 employees. The announcement serves as notification fulfilling the government’s synopsis requirements and emphasizes that the special request for information is not a solicitation for quotes but a step to verify whether a competitive acquisition is feasible before proceeding with the sole source award to Abbott Laboratories.

General Info

USAMRAA awards sole source contract to Abbott for HIV-1 genotyping test kits.

Agency

N/A

NAICS

325413 - In-Vitro Diagnostic Substance Manufacturing

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

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Posted

special-notice

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Full Description

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This notice announces the intent by the U.S. Army Medical Acquisition Activity (USAMRAA), 820 Chandler St, Fort Detrick, Maryland, 21702, intends to award a sole source contract to Abbott Laboratories for Abbott ViroSeq HIV-1 Genotyping Reagent v2.0 and the HIV-1 Integrase Genotype Reagent v2.0 test kits and consumables to support HIV-1 Resistance Genotype testing for the WRAIR HIV Diagnostics and Reference Laboratory (HDRL). The proposed contract action is for supplies for which the government intends to solicit and negotiate with only one source under the statutory authority 10 U.S.C. 2304 (c)(2). The FAR citation is 6.302-1(a)(2)(iii), Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. The primary mission of the WRAIR HIV Diagnostics and Reference Laboratory (HDRL), US Military HIV Research Program, WRAIR is to provide HIV screening and supplemental confirmatory testing for US Army and US Military Entrance Processing Command (MEPCOM) accession candidates, US Army Soldiers and their Beneficiaries, and our sister services; the US Navy and US Air Force including Dover Air Base, Armed Medical Examiner System, upon request. HDRL serves as the DoD Reference Laboratory for HIV-1 Diagnosis. A second mission is to provide molecular testing services for detection of the Human Immunodeficiency Virus (HIV) for confirmation of the diagnosis of HIV-1 and for monitoring of HIV-1 viral load, HCV viral load (upon request) and HIV-1 Genotype Resistance in HIV-1 infected US Army Soldiers and Beneficiaries to allow clinicians to provide appropriate treatment decisions. The Abbott ViroSeq HIV-1 Genotyping Reagent is the only FDA cleared assay for use in monitoring HIV-1 infected patients receiving drug therapy. The Abbott HIV-1 Integrase Genotype RUO Test is the only complete GMP manufactured kit available for use in determining mutations that confer resistance to Integrase drugs. An RFQ will be issued on a sole source basis. The North American Industry Classification System (NAICS) for this requirement is 325413 and the size standard is 500 employees. This announcement fulfills the synopsis requirements under FAR 5.102(a)(6) and 5.203(a). USAMRAA intends to publish a solicitation no sooner than 15 days after publishing this synopsis. This Special Request for Information is not a request for competitive quotes. Information received in response to this notice will be considered solely for the purpose of determining whether a competitive procurement is in the best interest of the Government. If no written responses are received by the date listed below, which reflects at least fifteen (15) days after the publication of this notice, the solicitation will be issued as sole source. All questions and responses concerning this notice shall be emailed to Ms. Amanda Best at contact@example.gov. Interested concerns must identify their capability to the above email address no later than 8:00 AM Eastern Time, 15 June 2015.

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