Intent to Sole Source Hologic - Assay Kits

The Centers for Disease Control and Prevention (CDC), Office of Infectious Diseases, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Division of HIV/AIDS Prevention, Laboratory Branch intends to award a sole source firm fixed price purchase order to Hologic Gen-Probe, for the purchase of Hologic - Assay Kits to evaluate and verify the HIV1 viral load assay systems on various blood specimens in the CLIA HIV laboratory to document accurate reporting of HIV results. The assay kits will be used on the recently purchased Hologic Panther system, the latest platform approved by the FDA for patient monitoring of HIV-1 viral loads. This system, used for detection of HIV-1 RNA, is the only method FDA-approved for HIV diagnostics. The Hologic Panther system is unique and uses its own system and own reagents/supplies. They cannot be substituted with any other platforms as they will not be compatible. In order to continue the CDC’s assay validation and testing, the program office must purchase the same Hologic assay kits. Hologic is the only company that sells the HIV-1 assays for this purpose in the United States. Therefore, to ensure consistency, Hologic Gen-Probe is the only vendor able to meet the Government’s need. This requirement is for supplies for which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b) (Simplified Acquisition Procedures and 10 U.S.C. 2304(c)(1). Interested vendors may identify their interest and capability to respond to the requirement. THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS; however, all responses received within five (5) days of the issuance of this notice will be reviewed 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 be considered solely for the purpose of determining whether to conduct a competitive procurement. Any response must be emailed to the contract specialist at [email protected] by December 21, 2020 by 12:00 PM EDT.