The Centers for Disease Control and Prevention intends to issue a sole source purchase order to Fluoresentric, Inc., 2700 W. Homestead Road, Suite 50, Park City, UT 84098-5820, for acquisition of real-time PCR singleplex assays for botulinum toxin genes. The PCR assays are required for support of Federal, State, and local public Health laboratories to detect Clostridium botulinum using existing protocols and platforms. The assays designed and developed by Fluoresentric contained pre-mixed and lyophilized proprietary primer and probe oligonucleotides. The vendor will supply quality-controlled PCR assays using previously designed oligonucleotides proprietary to the vendor. In order to ensure the assays perform as required, the assay must contain the identical oligonucleotide sequence and have the same specificity and sensitivity. The PCR assays must contain lyophilized real-time PCR primers and probes specific for botulinum toxin genes and be stable for up to 24 months. Assays are required to have no cross-reactivity to other Clostridium spp., between non-specific botulinum toxin genes, or among enteric bacterial pathogens. The vendor must perform quality control (QC) testing on the assays to meet specifications described above and provide CDC with the QC results and a certificate of analysis. The vendor will label the vials using CDC-supplied templates and must provide technical support services by telephone and/or internet. CDC believes that this requirement is met by only one provider. This procurement will be processed under the authority of FAR 13.106-1(b)(1). Only one responsible source and no other sources will satisfy agency requirements. No solicitation is being issued. Interested persons may use e-mail to identify their interest and capability to respond to this requirement before the expiration date of the advertisement. This procurement is not set-aside for small business. For contractual questions contact Linda M. Young.

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