JA Redacted.pdf

This document provides a justification and approval for other than full and open competition for contract number 75D30123C16444 awarded by the Centers for Disease Control and Prevention to Biosearch Technologies, Inc. on April 26, 2023. The contract value is $399,993 and provides for the manufacture of 1,020 vials of oligonucleotide primers and probes per ISO-13485 utilizing Good Manufacturing Practices by September 25, 2023. Biosearch Technologies is the only source that can manufacture the probes with the specific internal BHQnova quencher design required for the FDA-approved FluSC2 Multiplex diagnostic assay under this acquisition. To date, the CDC has not identified another company with the capability and production capacity to manufacture the probes with the required internal quencher design and quality level needed for the FDA-approved FluSC2 Multiplex assay.