Adaptable Multiflow Diagnostic Platform to Genetically Identify Drug Resistant Infection

ended

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.