Notice of Intent to Sole Source the production of oligonucleotides to BioSearch Technologies

The Centers for Disease Control and Prevention intends to award a sole source firm-fixed-price contract to BioSearch Technologies, Inc . The purpose of this acquisition is for the manufacture and supply of large quantities of oligonucleotides containing the BHQnova quencher needed for the oligonucleotide probes in ISO-13485 quality levels. The services and supplies needed include the manufacture and shipment of GMP quality oligonucleotides in ISO family using CDC design specifications and using validated processes for synthesis, purification, filling, drying, and quality control to general materials. The CDC specifications require oligonucleotides primers and probes with specific internal BHQnova quencher molecules. Through the Market Research process, it was determined that BioSearch was the only vendor with the capability to supply the specific oligonucleotides primers and probes with specific internal BHQnova quencher CDC requires for this assay. Additionally, the assay must meet FDA standards as the FDA will not allow for any substitution of already approved essential materials that make up the assay. Furthermore, BioSearch is the only FDA approved manufacturer of these oligos that can generate a dried version of this product . 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 13.106-1(b) and 10 U.S.C. 3406. Interested persons may identify their interest and capability to respond to the requirement or submit quotes. This notice of intent is not a request for competitive quotations; however, all quotations/responses received within 14 calendar 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. Any quotation/response should be emailed to contract specialist at [email protected] by COB 15 April, 2024 .