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development of diagnostic tests

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69739Federal

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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.

General Info

CDC awards sole-source contract to Hologic for automated gonorrhoeae resistance detection tests.

Agency

N/A

NAICS

541720 - Research and Development in the Social Sciences and Humanities

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

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Organization & Contact Information

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AgencyN/A
Contacts1 person available
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Organization / Agency
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Office AddressN/A
Contacts
Deborah T WorkmanContract Specialist

Full Description

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This is a notice of intent to award a sole-source purchase order and is not a request for competitive proposals. The Centers for Disease Control and Prevention(CDC) , National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Office of the Director (NCHHSTP), intends to solicit and enter into a contract with Hologic Inc, 10210 Genetic Center Drive, San Diego, CA, 92121. Hologic intends to develop fully automated nucleic acid amplification test (NAAT's) for detecting genetic antibiotic resistance (AR) markers in Neisseria gonorrhoeare (NG). These assays will use existing technology (chemistry, hardware and software ) within Hologic and will be designed to run on the same fully automated FDA approved instrumentation system as the Aptima Combo2 test. The Aptima based assays are based on the Hologic Tigris instrumentation or technologies. The Government intends to solicit, negotiate and award to only one contractor using other than full and open competition procedures pursuant to the authority of FAR 13.106-1(b)(1). The NAICS code for this acquisition is 541720 and the size standard is 500 employees. This requirement will be procured under the guidelines of FAR Part 12, Commercial Items. Award will be made using Simplified Acquisition Procedures, FAR Part 13. Interested parties should submit a capabilities statement demonstrating their ability to provide the required system to Deborah T. Workman by email at atl7@cdc.gov. This notice of intent is not a request for competitive proposals; however, the Government shall consider all responses received. A determination by the CDC not to compete this proposed contract, based upon responses to us notification, is solely within the discretion of the Contracting Officer.

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