Notice of Intent to Sole Source - BioSearch Technologies INC.

The Centers for Disease Control and Prevention (CDC) intends to sole source a contract to BioSearch Technologies INC. for the manufacture, assembly, and delivery of real-time polymerase chain reaction (PCR) primer and probe kits. The contractor will be responsible for pilot production, full-scale production, quality assurance activities, labeling, packaging, and delivery of approved kits. The kits must meet Government-defined technical specifications, including the use of Black Hole Quencher (BHQ) probe chemistry and compliance with FDA Quality System Regulations. The scope of work includes: • Primer and probe synthesis • Pilot batch production • Full-scale manufacturing • Quality assurance • Kit assembly • Labeling • Packaging • Delivery of finished kits The contractor must also comply with detailed technical, quality control, security, and kit assembly requirements described at the task order level.