Development of a rapid point-of-care antimicrobial susceptibility testing diagnostic medical device
Awarded
The competition has ended and a winner has been selected.
- Qualification deadline
- Dec 8, 2025Expired
- Award
- Pris 30%
Brief
Health and Digital Executive Agency (HaDEA) in Belgium has entered into an agreement with SHANX MEDTECH B.V., AIDIAN OY, FUNDACION PARA LA INVESTIGACION BIOMEDICA DEL HOSPITAL UNIVERSITARIO RAMON Y CAJAL, BIOSURFIT SA, and UNITRON INNOTECH BV for the development of a rapid point-of-care antimicrobial susceptibility testing diagnostic medical device. The services are to be delivered over 4 years, with a final contract value of 8.85 million EUR. The project aims to develop a diagnostic medical device that can provide antimicrobial susceptibility results on bacteria or fungi causing human infections within one hour or less from sample collection, ideally also allowing for pathogen identification. The proposed product should be at a minimum Technology Readiness Level (TRL) 3 with a clear pathway for CE marking in the EU, aiming to reach TRL 8 by the end of the contract. Ten bids were received for this contract.
Statistikk og markedsundersøkelser
Result
- AIDIAN OYWinner
- BIOSURFIT SAWinner
- FUNDACION PARA LA INVESTIGACION BIOMEDICA DEL HOSPITAL UNIVERSITARIO RAMON Y CAJALWinner
- SHANX MEDTECH B.V.Winner
- UNITRON INNOTECH BVWinner
- 10Number of bids
- €8,850,000Contract value
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Description
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From the notice
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.
Contact
hadea-procurement@ec.europa.eu- Result · PrequalificationType
- 73000000Main codeResearch and development services and related consultancy services
- 73300000Design and execution of research and development