Intent to Sole Source Procurement and Delivery of Ready-to-Use Lateral Flow Assay Cassettes for Detection of Antiretroviral Drugs in Human Specimens

The Centers for Disease Control and Prevention intends to award a sole source firm fixed price purchase order to NanoComposix, Inc for lateral flow assay design and manufacture services using antibodies developed at the CDC, to detect antiretroviral drugs.Due to the intended use of the devices, the CDC is limited to vendors that have the capacity to manufacture under GMP and have worked with the FDA on device approvals. NanoComposix is the only company that provides superior nanoparticle technology for LFA development, while also delivering clinical grade assays for evaluation, and providing strong support for the FDA application and approval process. In addition, NanoComposix was awarded PO# 200-2021-M-12824 previously for the LFA we need. Migration of the project to a new vendor would require a significant investment of time and resources to re-configure the LFA device with the competitor’s technologyThis 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. 2304(c)(1). 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 quotations; however, all quotations/responses received within fifteen (15) 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 DThreatt2@cdc.gov by 10:00AM EST September 8,