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Adaptable Multiflow Diagnostic Platform to Genetically Identify Drug Resistant Infection

Periodic Reporting for period 1 - mfloDx (Adaptable Multiflow Diagnostic Platform to Genetically Identify Drug Resistant Infection)

Reporting period: 2019-12-01 to 2020-03-31

Globally, about 4000 people die every day due to Tuberculosis (TB). TB is curable if detected at early stages and treated with correct antibiotics. If not treated, the TB bacteria develops resistance and becomes a challenge for treatment. The alarming incidence of drug-resistant forms of TB are 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 drug-resistant TB in the community. To address this problem, EMPE Diagnostics AB, Sweden has developed mfloDx® technology that can rapidly detect the TB causing bacteria and its drug-resistance profiles in less than 3 hours, directly from the sputum samples.

The aim of the project is to generate a feasibility report to determine the practical business and economic viability of the innovative mfloDx® platform in the largest TB diagnostic market, India. The objectives of the project were to establish supplier setup, certification and regulatory requirements, and possibilities for distribution; to run pricing models, expand IP, and to finalize business plan.
Agreements for supply of raw materials required for the manufacturing of mfloDx® test kits are in place. Further, local suppliers in the target market have been identified to reduce cost. A roadmap for Invitro Diagnostic Devices (IVD) approval in India was prepared and a `No objection certificate´ from the Indian regulatory body was obtained for manufacturing the test kits in India. After successful clinical performance validations on Indian samples, the first product, mfloDx® miniMDR-TB is released for Research Use Only (RUO) commercial sales. Potential customers and distributors across India have been identified and discussions are ongoing to understand willingness to buy, optimize cost price and margins. Patents on our key technologies were assessed for Freedom-to-Operate (FTO) in India and we found no infringements to granted Indian patents. Results from this project facilitated to test our market feasibility and enabled us to update our business plan.
The mfloDx® tests provide confirmatory clinical information about TB infection and its antibiotic resistance pattern in less than 3 hours. This test is lifesaving, because the clinician can start immediate treatment with appropriate antibiotics, even at the first visit. Additional funding is required for market entry and scale-up of production to achieve global sales of mfloDx® test kits. Our estimates suggest that mfloDx® would reduce the treatment costs per MDR-TB patient by tens of thousands of euros and diagnosis time from months to hours, reduce patient suffering, and curtail the spread of drug-resistant bacteria.