Intent Purchase of African Swine Fever Virus (ASFV) DNA Test Kits #644

06/15/2022 12639522Q1069534 - Intent to Purchase of African Swine Fever Virus (ASFV) DNA Test Kits. The USDA intends to award a sole source Firm Fixed Price purchase order under the statutory authority permitting Other than Full and Open Competition per statutory authority is 41U.S.C. 253(c)(1) FAR 6.302-1 to Tetracore LLC; UEI V7HKYLEP7N37. They are listed as a small business under the NAICS intent to use for purchase 334516. The property or services needed are available from only one responsible qualified source at this time in which is proprietary to only this manufacture. The kit is the only real time PCR Kit kit which is licensed by USDA for testing ASFV and available for distribution within the U.S It is the first USDA licensed diagnostic product for ASFV and is manufactured in the United States. No other type of property or services can provide all required performance as stated in the scope of work. Tetracore LLC is the manufacturer of these tests. History The African Swine Fever Virus (ASFV) DNA Diagnostic Test has been validated in studies with multiple study partners including: (1) Centro de Investigación en Sanidad Animal, Instituto Nacional De Investigaciones Agrarias (CISA-INIA, Spain); (2) The National Veterinary Institute (SVA, Sweden); (3) Sciensano (Belgium); and other International and US laboratories, where the test demonstrated equivalent performance compared to the reference test methods used by the study partners. There is no other kit that is licensed and available in the US for distribution which has been validated by study partners. Additionally Tetracore holds a USDA manufacturing license, #644 and has the physical space and Quality Management System in place to manage bulk storage requirements. Tetracore also has the surge capacity in production to meet this bulk order in very short notice Small business concerns are encouraged to participate. This notice of intent is NOT a request for competitive proposals, but instead a market research method to determine interested sources. A determination by the Government not to compete this proposed action is based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose to determine whether conducting a competitive (i.e. non-brand name) procurement is in the best interest of the Government. Interested sources who submit data are responsible for appropriately marking information if it is proprietary in nature. Please provide past performance and references regarding your ability to provide this supply and service along with your Statement of Capability. The Government will not award a contract based on the information received, nor reimburse participants for information they provide. Information provided is strictly voluntary. Please email Statements of Capability to Tom Wesley: [email protected]. Telephonic inquiries will not be honored. Closing date for submission of Statements of Capability is 21 June 2022 at 3:00e PM Central Standard Time. The North American Industry Classification Code (NAICS) is 334516. Ship to the following location: USDA-APHIS-VS-NVSL 1920 Dayton Avenue Ames IA 50010