GMP Manufacturing of CDC FluSC2 Multiplex EUA Kit

The Centers for Disease Control and Prevention intends to award, on a sole source basis, a firm fixed price contract to Biosearch Technologies, Inc., 2199 S McDowell Blvd, Petaluma, CA 94954, for the manufacture of quantity 1,020 vials of oligonucleotide primers and probes per ISO-13485 utilizing Good Manufacturing Practices (GMP) as defined under 21 CFR 820.  Estimated complete delivery is 5 months from date of award.  These primers and probes are to be utilized by the CDC in development of diagnostic FluSC2 Multiplex assay test kits.  Through previous efforts, the CDC Influenza Division obtained Food and Drug Administration (FDA) clearance of these test kits and distributes the test kits to a network of public health laboratories.  Development and manufacture of these tests in accordance with FDA regulations requires compliance with Title 21 of the CFR.  These standards and restrictions flow down to the manufacturer of essential material, including the oligonucleotide primers and probes, and require FDA approval for Emergency Use Authorization (EUA).  Specifically, Biosearch Technologies in the only source that is approved by FDA EUA to manufacture GMP ISO 13485 quality level oligonucleotide primers and probes with specific internal BHQnova quencher that is needed for the diagnostic FluSC2 Multiplex assay.  Other known sources have the ability and approval to manufacture probes with internal ZEN quencher, but not the required BHQnova quencher, which makes Biosearch Technologies unique in its capability.                

This contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302-1 and 41 U.S.C. 3304(a)(1).  Interested persons may identify their interest and capability to respond to the requirement or submit proposals. 

This notice of intent is not a request for competitive offers; however, all offers/responses received within 15 days of the issuance of this notice will be considered by the Government.  A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.  Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.  All offers/responses should be emailed to Mark Draluck at syq1@cdc.gov by 5:00 P.M. Eastern Time, 17 February 2023.