GMP Manufacturing of CDC FluSC2 Multiplex EUA Kit
Awarded Limited / Sole Source Justification Posted
A newer pre-solicitation was posted. See the latest pre-solicitation from .
- Solicitation number
- 75D30123C16444
- Agency
- CDC Office of Acquisition Services Centers for Disease Control and Prevention, Department of Health and Human Services
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- 75D30123C16444 Federal contract award
- NAICS code
- 325413 In-Vitro Diagnostic Substance Manufacturing
- Place of performance
- Petaluma, California 94954, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Centers for Disease Control and Prevention published this Limited/Sole Source Justification Notice to provide 1,020 vials of oligonucleotide primers and probes manufactured under Good Manufacturing Practices by September 25, 2023. The contract was awarded noncompetitively to Biosearch Technologies, Inc. in the amount of $399,993. According to the attached justification and approval document, Biosearch Technologies is the only source that can provide the probes with the specific internal BHQnova quencher design required for the FDA-approved FluSC2 Multiplex diagnostic assay, as the CDC has not identified another company with the capability and production capacity to manufacture probes meeting the required design, quality level, and timeline to support this acquisition.
Notice text
CDC awarded contract number 75D30123C16444 to Biosearch Technologies, Inc., 2199 S McDowell Boulevard EXT, Petaluma, CA 94954, on 26 April 2023, in the amount of $399,993.00.
This notice makes available a Justification and Approval for Other than Full and Open Competition (J&A) that applies to this contract.
This contract was issued under the authority of FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.
This contract provides 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. The required delivery date is 25 September 2023.
In accordance with the attached J&A, Biosearch Technologies is the only source that can manufacture oligonucleotide primers and probes with specific internal BHQnova quencher design that is needed for the diagnostic FluSC2 Multiplex assay which is approved for Emergency Use Authorization (EUA) by the FDA in GMP ISO 13485 quality level. FDA will not allow any substitution of already approved essential materials that make up the assay which has been approved for EUA. Other sources can manufacture the FDA approved FluSC2 Multiplex assay, but that FDA approved assay does not provide for the specific internal BHQnova quencher design required under this acquisition. To date, CDC has not identified another company who has the capability to manufacture the probes with internal BHQnova quencher with the requisite quality and production capacity.
The attached J&A is being made available within 14 days of contract award in accordance with FAR 6.305(a) and will remain active for 30 days in accordance with FAR 6.305(d)(3).
Awarded contract 75D30123C16444 to unknown vendor for unknown amount on 2023-04-26.
Attachments
| File | Type | Posted |
|---|---|---|
| JA Redacted.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| Modification to Contract 75D30123C16444 (GMP Manufacturing of CDC FluSC2 Multiplex EUA Kit) | Pre-Solicitation | |
| GMP Manufacturing of CDC FluSC2 Multiplex EUA Kit | Limited / Sole Source Justification | |
| GMP Manufacturing of CDC FluSC2 Multiplex EUA Kit | Pre-Solicitation |
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