A novel in-vitro diagnostic test for drug-resistant tuberculosis and a personalized antibiotic treatment plan.

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Company: Clemedi AG is a Swiss SME, founded in 2019 as a spin-off from the University of Zurich, with the aim to develop in vitro diagnostic (IVD) tests for antibiotic resistance and susceptibility in infectious diseases. The vision of Clemedi is to support the global battle against antibiotic resistance by developing IVDs that will allow personalized prescription of antibiotics. Need to address: Antimicrobial resistant infections will be among the world’s leading causes of death by 2050. Multi-drug-resistant tuberculosis (MDR-TB) is a large contributor to death by antimicrobial resistance, with over 240k global mortalities (of which 10k in Europe) per year. Many of these are caused by the inability to detect resistance and antibiotic susceptibility in the diagnostic process. Solution: Clemedi is developing a unique platform to rapidly diagnose drug-resistant infectious diseases, including MDR-TB, and rapidly provide a matching therapy plan. The platform uses proprietary primers to amplify specific DNA from patient samples, followed by next-generation sequencing (NGS) analysis. Machine-learning algorithms are then used to annotate the NGS data, and determine susceptibility or resistance based on DNA-profiles to provide a focused advice on antibiotic therapy, within 24-48 hours after obtaining a patient’s sample. Business opportunity: The minimum total addressable market for Clemedi (i.e. every person that needs to be diagnosed for MDR-TB) is valued at €73.7 M. Competitors are companies that also develop IVDs for rapid detection of MDR-TB, such as Hain Lifescience, Cepheid and Becton-Dickinson. The main competitive advantage of Tuberculini is its ability to analyze susceptibility for a significantly larger number of antibiotics (12 vs. 1-5). Only this can positively impact disease management. Feasibility study: Financial support from the SMEi P1 will be used to assess the technical and commercial feasibility of Tuberculini, Clemedi’s IVD for MDR-TB.