The Centers for Disease Control and Prevention intends to award a sole source firm fixed-price purchase order to Hologic, Inc. at 250 Campus Dr., Marlborough, MA 01752-3020 for a Panther Fusion Instrument System. Because this instrument allows for laboratory-developed tests (LDTs) through the Fusion component, specialized tests -including those focusing on antimicrobial resistance (AMR) markers - can be validated and run which enhances detection and diagnostics of pathogens. This provides testing capabilities not afforded through the use of other widely-used and commercially-available instruments. Also, the Panther system can run the only currently FDA-approved test for Mycoplasma genitalium, which allows for greater strengthening of molecular surveillance of this emerging STD pathogen. The Laboratory Reference and Research Branch (LRRB) conducts clinical testing for various sexually-transmitted pathogens under Clinical Laboratory Improvement Act (CLIA) standards. This new equipment will replace an existing older instrument and add additional features (such as the ability to concurrently run LDT and commercially-available tests). No other commercially-available system is compatible with the program's existing validated tests. 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)(SAP) and 41 U.S.C. 3304(a)(1). Interested persons 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 fifteen (15) 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 should be emailed to the Contract Specialist at [email protected] by 10 a.m. on COB 04/17/2019.

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