SOLICITATION NOTICE
65 -- Notice of Intent to Sole Source to Roche
- Notice Date
- 9/27/2006
- Notice Type
- Solicitation Notice
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMLC, 1681 Nelson St, FT Detrick, MD, 21702-9203
- ZIP Code
- 21702-9203
- Solicitation Number
- Reference-Number-N62645-06-ROCHE
- Response Due
- 9/28/2006
- Archive Date
- 10/1/2006
- Description
- The Naval Medical Logistics Command intends to negotiate on a sole source basis (IAW FAR 6.302-1) with Roche Diagnostics Corporation, 9115 Hague Rd, Indianapolis, IN 46250 as the only responsible source that can provide diagnostic kits including precision equipments used for in-vitro nucleic acid amplification and quantization of HIV type I RNA; Nomenclature: Amplicor HIV Monitor kit, #21118560018. Specifically, NMCSD Molecular Diagnostics Laboratory along with the Infectious Disease Wards has established a required test range of 50 to 100,000 copies per milliliter. Roche Diagnostics is the only manufacturer of ultra sensitive HIV monitoring test kits with a dynamic range of 50 to 100,000 copies per milliliter. Roche Diagnostics Corporation manufactures the diagnostic kits and reagents used for in-vitro nucleic acid amplification and quantitation of HIV type I RNA (nomenclature: Amplicor HIV Monitor kit, #21118560018). Roche Diagnostics, provides controls, reagents, and equipment used in assessing viral response to anti-retroviral treatment. The Navy has an established test range accuracy of 50 to 100,000 copies per milliliter. Roche Diagnostics Corporation is the only manufacturer in the US of ultra sensitive HIV monitoring diagnostic kits and reagents with the required dynamic range. The diagnostic kits are used to diagnose patients who may have a terminal illness. Changing to another manufacturer will result in having to completely stop current methodologies of testing to validate /correlate the new system and new consumables. This will disrupt patient continuity of care, because validation studies is a very tedious process and takes significant time before patient?s reports have results. The current HIV method being used is a PCR quantitative methodology. The quantitation of results is needed by our Infectious Disease doctors to monitor therapy for known HIV patients. Based on the above information, the only technically acceptable items are the diagnostic kits including precision equipments used for in-vitro nucleic acid amplification and quantization of HIV type I RNA; Nomenclature: Amplicor HIV Monitor kit, #21118560018. This acquisition is being conducted under simplified acquisition procedures. There are no set-aside restrictions for this requirement. The intended procurement will be classified under North American Industry Classification System (NAICS) 423450 with a Small Business Size Standard of 100 employees. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice shall submit technical data, including cost, sufficient to determine capability in providing the same product. All capability statements received within 1 day after publication of this synopsis will be considered by the Government. A determination by the Government not to compete 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. Capability statements shall be submitted by email only as a MS Word or Adobe PDF attachment to Richard Taylor at rtaylor@nmlc.med.navy.mil. Statements are due by 1600 (4:00 PM) Eastern Time 28 SEPT 06. No phone calls accepted.
- Place of Performance
- Address: Naval Medical Center San Diego, 34800 Bob Wilson Dr.`, San Diego, CA
- Zip Code: 92134-5000
- Country: UNITED STATES
- Zip Code: 92134-5000
- Record
- SN01156102-W 20060929/060927221037 (fbodaily.com)
- Source
-
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