development of diagnostic tests
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The Centers for Disease Control and Prevention (CDC), through its National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Office of the Director, intends to award a sole-source purchase order to Hologic Inc. This contract aims to develop fully automated nucleic acid amplification tests (NAATs) to detect genetic antibiotic resistance markers in Neisseria gonorrhoeae. Utilizing Hologic's existing chemistry, hardware, and software technologies, these assays will operate on the FDA-approved Hologic Tigris instrumentation system, which also supports the Aptima Combo2 test. The contract will be awarded without full and open competition under the authority of FAR 13.106-1(b)(1), with procurement conducted according to FAR Part 12 for commercial items and Simplified Acquisition Procedures under FAR Part 13. The solicitation corresponds with NAICS code 541720 and is designed for small businesses with up to 500 employees. Although this notice is not a request for competitive proposals, interested parties may submit capability statements to demonstrate their qualifications. The final decision on whether to compete the contract after reviewing responses rests with the CDC Contracting Officer. Deborah T. Workman serves as the Contract Specialist and point of contact for submissions and inquiries. The overall intention is to advance diagnostic testing capabilities for antibiotic resistance, aligning with public health priorities related to sexually transmitted infections.
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