--Intent to award sole source for the continuation of research used in support of validation studies for 510(K) submission to Federal Drug Administration.

The US Army Medical Research Acquisition Activity intends to award a sole source contract to Cepheid, located in Sunnyvale, California, for the procurement of Leishman PCR Beads. The contract supports ongoing research critical for validation studies related to a 510(K) submission to the Federal Drug Administration. Switching vendors at this stage of the research could invalidate prior study results and lead to duplicated costs for the Government. Thus, only Cepheid can meet the agency’s specific requirements due to their unique capability to provide these specialized supplies. This procurement follows the full and open competition procedures outlined in FAR 6.301-1 but is justified under the basis that only one responsible source exists, ensuring no other suppliers or services can fulfill the needs of the agency. The contract is tied to NAICS code 541380, which pertains to testing laboratories, reflecting the technical and specialized nature of the contract. This notice serves as an intent to award and is not a solicitation for competitive quotes.