Antimicrobial resistant infections affect an ever-increasing number of people and will be among the world’s leading causes of death by 2050. In particular, multi-drug resistant tuberculosis (MDR-TB) is a large contributor to death by antimicrobial resistance with more than 230,000 mortalities per year. Many MDR-TB mortalities are caused by the inability to detect resistance in the diagnostic process, leading to delayed choice of therapy, prolonged hospitalizations and avoidable spread of pathogens. To halt the spread of MDR-TB, there is an urgent need for earlier and more accurate detection of drug-resistant pathogens. The lack of such innovations may rapidly increase the incidence of drug-resistant TB infections that require highly complex and expensive treatment regimens. To prevent the need for such complex and expensive treatments, it is of critical importance to establish appropriate interventions as early as possible.
Addressing this need, Clemedi is developing Tuberculini: a unique and proprietary test to accurately detect MDR-TB pathogens based on advanced DNA sequencing methods. Following DNA sequencing, Tuberculini applies machine to provide clinicians with an actionable report within 24-48 after diagnosis, including tailored advice on antibiotic therapy.
The overall objectives of this project was to evaluate the technical and commercial feasibility of Tuberculini, especially in countries with a high TB-burden. Technical feasibility sought to analyse requirements for WHO endorsement of the test, which would allow Clemedi to reduce the price of Tuberculini in low-income countries. Commercial feasibility analysed the opportunity to implement Tuberculini in various high TB-burden countries with respect to the healthcare system, infrastructure, regulatory framework and other potential barriers.
Based on this project, it was concluded that implementation of Tuberculini is highly feasible, particularly in India. Profound insights were obtained on WHO requirements, the market in high-burden countries, regulatory pathways and the go-to-market strategy. Moreover, technical and commercial risks were identified for which mitigation measures can now be incorporated in the business strategy. These findings significantly matured Clemedi’s business plan. Based on this feasibility study, Clemedi has the instruments to attract further funding to finance further development to bring its technology towards the market.
