Notice of Intent to issue a Sole Source Award to support development and validation of novel ARV detection methods.

The Centers for Disease Control and Prevention Division of HIV Prevention (DHP)/Laboratory Branch (LB) intends to award a sole source firm fixed price purchase order to Emory University to support development and validation of novel ARV detection methods by obtaining freshly collected, matched biological specimens from individuals receiving ARVs for HIV treatment or prevention, and from individuals not receiving ARVs for developing assay controls. Emory University will collect fresh matched samples of whole blood and urine within the project timeline and deliver to CDC DHP Laboratory Branch staff within 24 hours of specimen collection to allow for CDC’s analysis using research use only (RUO) assays that employ novel methods for measuring ARVs. CDC is assessing novel assays to provide results consistent with those obtained by LC-MS-MS, as well as the convenience of the assays (sample extraction, time to run, etc.) to inform the next stages of development for these innovative tools. This contract action is for commercial services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 12.102-1. NAICS 541715 - Medical research and development laboratories or services (except biotechnology and nanotechnology research and development). Emory University is the only source that can deliver freshly collected biological specimens within a few hours, without compromising the integrity of the specimens as required. There are no other companies or state licensed medical clinics located within a resonable distance from the CDC to provide the services described above. This notice of intent is not a request for competitive quotations; however, all Quotations/ responses received within 15 days of the issuance of this notice shall be considered by the government. A determination by the government not to complete 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 the contract specialist at email zvm0@cdc.gov by 06/02/2026.