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

Project Information

Tuberculini

Grant agreement ID: 877807

DOI

10.3030/877807

Project closed

EC signature date 18 July 2019

Start date 1 August 2019

End date 31 January 2020

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

CLEMEDI AG
Switzerland

Periodic Reporting for period 1 - Tuberculini (A novel in-vitro diagnostic test for drug-resistant tuberculosis and a personalized antibiotic treatment plan.)

Reporting period: 2019-08-01 to 2020-01-31

Summary of the context and overall objectives of the project

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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The work performed in this project included a desk study and interviews with key opinion leaders (KOLs). The desk study covered the technical feasibility with regard to WHO requirements for the use of diagnostic TB tests based on next-generation sequencing. The commercial feasibility study entailed a desk study concerning the country-specific healthcare system, TB-burden, infrastructure and regulatory framework of i) The five EU major markets ii) India iii) Pakistan iv) Bangladesh and v) Philippines. The desk study was complemented by six interviews with KOLs with extensive knowledge on TB, the implementation of diagnostic tests and the healthcare system of the above countries.

The main results achieved so far include a ranking framework for our preselected countries, a regulatory timeline and a sales forecast for three distinct business models. Moreover, all criteria for WHO endorsement have been investigated and ranked according to the degree to which they are addressed. For unaddressed WHO endorsement requirements, a development plan has been made.

The feasibility study will be used as a primary source for updating Clemedi’s business plan and implementation of Tuberculini in the five EU major market, India and at a later stage Pakistan and The Philippines. The results will be disseminated to our research partners and KOLs either within a collboartive framework or published in research journals if applicable. Some parts of the study will be used to communicate with potential investors, stakeholders such as WHO, FIND and health ministries.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The World Health Organizations described next-generation sequencing to detect TB as an approach that can overcome many of the significant challenges associated with conventional, less comprehensive molecular tests. Provided with the high urgency to halt MDR-TB infections, the use of next-generation sequencing is highly needed in countries with a high-TB burden in order to reduce the spread of pathogens, complex treatment regimens and associated societal costs.

Clemedi positively assessed the feasibility of Tuberculini and thereby acts upon the need for novel diagnostic tests that are able to detect TB based on comprehensive next-generation sequencing technology. This will have a positive impact on early detection on MDR-TB, which will consequently results in fewer mortalities, more effective treatment and lower societal costs.

The benefits of Clemedi’s test Tuberculini for MDR-TB compared to conventional diagnostic methods.