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 results on the bacteria or fungi causing an infection in humans, within one hour or less from subject 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 call 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.