Notice of Intent to Sole Source - BioSearch Technologies INC.
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The Contractor is obligated to manufacture, assemble, perform quality control, package, and deliver real-time polymerase chain reaction (PCR) primer and probe kits according to government-approved technical and manufacturing specifications, applicable regulatory standards, and individual delivery orders under the Blanket Purchase Agreement. The kits must be commercially produced, dried or lyophilized, and fully compliant with FDA Quality System Regulations (21 CFR 820), using Black Hole Quencher (BHQ) probe chemistry to ensure compatibility with existing validated assays. The Contractor is responsible for the full end-to-end production lifecycle, including synthesis of primers and probes, pilot and full-scale manufacturing, quality assurance, kit assembly, labeling, packaging, and final delivery, all performed at the Contractor’s facilities unless otherwise approved. All technical, quality control, security, and assembly requirements are detailed in individual task orders issued under the agreement and are binding when invoked. The Contractor must securely handle sensitive primer and probe sequences and adhere strictly to the specifications outlined in each task order. The procurement is being conducted as a sole source action under the CDC Office of Acquisition Services, with the place of performance located in Atlanta, Georgia. The contract vehicle is linked to NAICS code 325199 and is managed by the Department of Health and Human Services, with point of contact Marcus Lindsey available for inquiries via email and phone. The notice of intent was posted on July 8, 2026, with responses due by July 23, 2026.
General Info
Agency
NAICS
Place of Performance
Atlanta, GA, 30341, USASet-Aside
Documents
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Full Description
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.
