Development of a rapid point-of-care antimicrobial susceptibility testing diagnostic medical device

HaDEA has published the EU4Health call for tenders HADEA/2025/CPN/0006 on the development of a rapid point-of-care antimicrobial susceptibility testing diagnostic medical device. 

This call for tenders aims to speed up the development of a point-of-care diagnostic medical device that can provide antimicrobial susceptibility testing (AST) results on the bacteria or fungi causing an infection in humans, within one hour or less from sample collection, and ideally, to also allow for pathogen identification. Diagnostic tests that allow for pathogen identification (in addition to AST) should aim at identifying at least one of the bacteria listed in the 2024 WHO bacterial pathogen priority list and/or the fungi Candida spp., and/or Aspergillus fumigatus.

The calls aims to speed up the development of rapid, point-of-care AST devices currently in the pipeline. The proposed product shall be at minimum technology readiness level (TRL) 3 onwards with a clear pathway for CE marking in the EU. By the end of the contract, the product developed should aim at reaching system complete and qualified (TRL 8). Tenders aiming at early TRLs will be considered, as long as the product is working towards certification. 

Estimated budget: €12 860 000

Please consult section 2.2 of the published tender specifications for information on who may submit a tender. Interested parties are invited to apply on the Funding and Tenders Portal. The deadline to apply to the first step of the procedure is 12 May 2025, 16:00 CET. Invitations to submit an offer for step 2 will be indicatively sent out at the beginning of June, with a deadline for step 2 indicatively in early September.