Notice of Intent to Sole Source - BioSearch Technologies INC.

Closed Special Notice Posted

Solicitation number
96005
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Atlanta, Georgia 30341, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The CDC Office of Acquisition Services issued a notice of intent to sole source a blanket purchase agreement (BPA) for manufacture and delivery of real-time PCR primer and probe kits to BioSearch Technologies Inc., with comments due by July 23, 2026.

The contractor shall perform end-to-end production including primer and probe synthesis, pilot batch production, full-scale manufacturing, quality assurance, kit assembly, labeling, packaging, and delivery. Supplies must be commercially manufactured, dried or lyophilized PCR primer and probe kits using Black Hole Quencher (BHQ) probe chemistry to maintain compatibility with validated assay designs. All work is performed at the contractor's facilities unless authorized otherwise by the Contracting Officer.

Compliance is mandatory with FDA Quality System Regulations (21 CFR 820), Government-approved technical specifications, manufacturing specifications, applicable regulatory standards, and individual delivery orders issued under the BPA. The contractor must demonstrate capability to securely handle sensitive primer and probe sequence information. Detailed technical, quality control, security, and kit assembly requirements will be incorporated by reference in applicable individual task orders.

The procurement is classified under NAICS 325199 (All Other Basic Organic Chemical Manufacturing) and PSC 6640 (Laboratory Equipment and Supplies).

Notice text

the Contractor shall manufacture, assemble, perform quality control, package, and deliver real-time polymerase chain reaction (PCR) primer and probe kits in accordance with Government-approved technical specifications, manufacturing specifications, applicable regulatory standards, and individual delivery orders issued under the BPA. The scope includes pilot production, full-scale production, quality assurance activities, labeling, packaging, and delivery of approved kits. 

The required supplies consist of commercially manufactured, dried or lyophilized PCR primer and probe kits that meet Government-defined technical specifications. These specifications include the use of Black Hole Quencher (BHQ) probe chemistry to maintain compatibility with validated assay designs, compliance with Food and Drug Administration (FDA) Quality System Regulations (21 CFR 820), and the capability to securely handle sensitive primer and probe sequence information.

The contractor shall provide end-to-end production, including primer and probe synthesis, pilot batch production, full-scale manufacturing, quality assurance, kit assembly, labeling, packaging, and delivery of finished kits.

Detailed technical, quality control, security, and kit assembly requirements are described at the task order level and will be incorporated by reference in applicable individual task orders. Compliance with such specifications is mandatory when invoked by task order. All work shall be performed at the Contractor’s facilities unless otherwise authorized by the Contracting Officer.

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