Notice of Intent to Sole Source the production of two lots of ISO quality level full genome synthetic SARS-CoV-2 RNA positive control (Part: 103727) from Twist Bioscience

The Centers for Disease Control and Prevention intends to award a sole source firm-fixed-price purchase order to Twist Bioscience. The purpose of this acquisition is to obtain two (2) lots of 1020 kits (each) of ISO quality level full genome synthetic SARS-CoV-2 RNA positive control (Part: 103727) that satisfies the specification of CDC influenza Division’s FDA-cleared diagnostic tests FluSC2 Multiplex Assay that is approved for Emergency Use Authorization (EUA) for detection of Influenza A, B, and SARS-CoV-2, the virus that causes COVID-19. FDA will not allow any substitution of already approved essential materials that make up the assay that has been approved for EUA. These materials are needed to meet the mission and requirements of public health surveillance. Through the Market Research process, it was determined that Twist Bioscience, is the only company that can provide the full genome synthetic SARS-CoV-2 RNA control materials needed for this assay. This contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b) and 10 U.S.C. 3406. Interested persons may identify their interest and capability to respond to the requirement or submit quotes. This notice of intent is not a request for competitive quotations; however, all quotations/responses received within 14 calendar days of the issuance of this notice will be considered by the government. A determination by the government not to compete 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. Any quotation/response should be emailed to contract specialist at [email protected] by COB 09 May, 2024 .