The objective of INNOVA4TB is to enhance and strengthen the collaborative research among sectors and to form a network aimed to perform high-quality and translational research in the field of diagnosis and management of tuberculosis (TB). The consortium is constituted by 12 institutions from 8 countries that combine complementary and synergic expertise: clinical management (hospitals), basic science and new technologies (academic institutions), and industrial development and entrepreneurship culture (SMEs). The exchanges between the institutions allow the participants to progress in their career perspectives. TB is one of the major infectious diseases worldwide, and the emergence and spread of drug resistant cases is a public health threat. However, the conventional methods used for diagnosis and drug-susceptibility testing are not enough for controlling the disease. In addition, all TB patients, independently of their age, gender, severity of the disease and type of responsible strain, follow the same treatment duration (up to 20 months in drug resistant cases), which often leads to high frequency of adverse events, suboptimal adherence to treatment, and poor outcome. A transition from programmatic to personalized management of TB is needed. Our proposal will develop innovative technologies and approaches in order to improve the individual risk assessment for TB development, to rapidly diagnose active TB, to detect the drug susceptibility of the strain, to design tailor-made therapies, and to use biomarkers to guide and individualize the duration of antimicrobial therapy. This is of great importance for improving the quality of life of patients and ensuring treatment success, as well as for economic reasons for the healthcare system.

Tuberculosis (TB) kills more people than any other pathogen-borne illness; yearly, 10M people fall ill and 1.6M die. TB also contributes to a growing existential crisis: the spread of antibiotic resistant bacteria. Multi-drug-resistant TB is flourishing due to incomplete diagnoses and widespread prescription of ineffective antibiotics. Commercial diagnostics often require equipment in the €12-70K range and are either very slow or incomplete. As a result, less than one-third of new TB patients undergo strain testing to determine whether antibiotic resistance is present. mfloDx is a low-cost, DNA-based TB diagnostic, similar to home-pregnancy tests. In <3 h, our test identifies nearly 100% of drug resistant TB strains with 92-97% accuracy, directly from sputum samples and with a minimum of lab equipment or training. Clinical validation is ongoing and we are preparing for in vitro diagnostic (IVD) certification for an estimated launch in late 2022. The low cost, accessibility, and stability of mfloDx tests will enable uptake in developing countries, which are the source of much antibiotic-resistant infection. EMPE‘s team are experts in TB research, business development, and diagnostic tools for infectious disease. mfloDx grew from a molecular innovation called the Padlock probe, developed by our co-founder, Mats Nilsson. EMPE CEO Pavan Asalapuram combined this technology with a lateral flow biosensor, as a fast and accurate kit to identify antibiotic resistance. EMPE has raised ~€2M in seed capital and started clinical validations with partners in Spain and India. Thus far, our facility at Karolinska Institute Science Park produces test kits for research use only (RUO). EIC funding would accelerate clinical validation of our kits toward in vitro diagnostic certification and enable the implementation of large-scale production. This project will enable us to launch our top-of-the-line product and reach a worldwide €3.5B TB diagnostics market with WHO backing.

Tuberculosis (TB) killed 33 million people worldwide in 2000-2015 and infects an estimated ¼ of the world population. Drug-resistant forms of TB are flourishing at an alarming rate due to faulty diagnosis and widespread prescription of incorrect antibiotics. Rapid and accurate detection of multi-drug resistant (MDR) strains is urgently needed to effectively treat patients and prevent spreading of untreatable TB forms. Simple, low cost diagnostic tools are needed to enable point-of-care testing in low- and mid-income countries. mfloDx is a low-cost, simple diagnostic platform that can identify close to 100% of drug resistant TB cases. Pilot tests of the first product, miniMDR-TB, showed the efficiency and specificity to be 92-96% in agreement with that of another molecular test recommended by the World Health Organization. Our next-generation mfloDx products, MDR-TB and MDR-TBplus, are expected to have close to 100% MDR-TB identification power. The low cost of mfloDx tests will enable market uptake in highly afflicted developing countries, and thereby help to stop the loss of life, the spread of antibiotic-resistant infections, and prevent unnecessary costs. Projected global expenditure on diagnosis and treatment of TB will reach €983 billion between 2015-2030. The addressable market for TB diagnostics is projected to grow to €3.1 billion by 2024. Available commercial diagnostics for MDR-TB often deliver incomplete diagnoses and require long lag times, costly equipment (€15-32K), and highly trained personnel to recommend prescriptions. As a result, less than one-third of new TB patients undergo testing to determine appropriate antibiotic treatments. Our estimates suggest that mfloDx would reduce the treatment costs per MDR-TB patient by tens of thousands of euros and diagnosis time from about six months to two hours. This would avoid costly and inappropriate antibiotic regimens, reduce patient suffering, and curtail the spread of drug-resistant bacteria.