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An Adaptable Multiflow Diagnostic Platform to Genetically Identify Drug Resistant Infection

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

Reporting period: 2021-03-01 to 2022-02-28

More than ten years have passed since the first molecular rapid test to diagnose tuberculosis (TB) was introduced, but still, only one in seven people in need of it have access to such a test. To diagnose all those suffering from the disease, TB programs need to perform at least 100 million rapid molecular diagnostic tests annually. However, in 2019 no more than 15% of this figure was reached.

TB is curable if it is detected in the early stages and treated correctly. However, a lack of reliable and timely diagnosis makes it difficult to ensure correct drug therapy. The bacteria develop resistance if it is not treated with correct antibiotics, which then becomes difficult and costly challenge for national TB programs. So, timely detection of resistance to the key drugs in TB therapy will reduce morbidity, mortality, and transmission of drug-resistant TB. Therefore, WHO recommends the broad use of rapid molecular tests for quick and correct diagnosis, worldwide.

The Covid pandemic, in addition to causing respiratory infections like TB, has severely harmed the world's health care structures. WHO has estimated that if TB detection is reduced by 50% over three months, the number of yearly TB deaths would increase by nearly 400 000. The Covid pandemic has thus made the need for improved diagnostics even more urgent.
Keeping up effective control of TB in a war situation and among huge groups of refugees is not possible. The ongoing situation in Ukraine is no exception and we can expect to see an increasing number of TB cases, especially the MDR-TB in the EU because they have about 30% of MDR-TB patients. Again, early and correct diagnosis is the key to limiting the problem.

The main objective of EMPE Diagnostics is to develop and offer reliable, user-friendly, and affordable rapid diagnostic TB tests to meet the global demand. We have developed a diagnostic platform that can detect the TB-causing bacteria (Mycobacterium tuberculosis) and resistance to the most important TB drugs in 3 hours. The test can be performed on sputum samples using standard laboratory equipment with limited technical skills and enables visual detection of markers of drug resistance, like a pregnancy test. Our tests are focused on low and middle countries where TB is a significant public health concern. It can be used near to the point of care eg. at medical camps, prisons, or refugee camps where it is essential to promptly detect TB and its antibiotic resistance. We can help to control TB and the spread of antibiotic resistance by offering timely diagnosis and enabling correct drug treatment.

If we cannot detect, we cannot treat, and they spread antibiotic resistance bacteria in the community casing socio-economic disturbance. EMPE Diagnostics’ is on the mission to stop the spread of antibiotic resistance by providing efficient diagnostic test kits, with the support of EIC grant.
The EIC-Accelerator project was started from 1st March 2021 and the following achievements are made, in one year until Feb 2022:

o Pragmatically streamlined our developmental activities to establish two products: mfloDx MDR-TB and mfloDx preXDR-TB.
o Established global manufacturing facility in India, following Indian regulations prescribed by the Central Drugs Standard Control Organisation (CDSCO). This factory is uprunning with qualified personnel and can produce 2 million tests per month.
o Implemented Indian regulatory and ISO 13485:2016 protocols.
o Obtained necessary permissions from Indian regulatory authorities for manufacturing the test batches and successfully produced 50000 tests (over pre -test batches and test batches).
o The first product, mfloDx MDR-TB technology was sequentially transferred from our R&D unit in Sweden to our global manufacturing facility in India. Optimized various parameters for large-scale production.
o At present, the mfloDx MDR-TB product is under performance evaluations at NIRT, the WHO Supranational Reference Laboratory of India. We aim to complete this study and start multicentric clinical evaluations in Q3 2022.
o Prototype of the second product, mfloDx preXDR-TB, which is our flagship and globally unique products is expected to complete its R&D phase by Q2 2022.
We have included the following aspects in our test kits:
o Usually, DNA extraction is the first step of any molecular test and takes time. We have developed a direct-lysis method and can directly work sputum samples making it simple and user-friendly, so that it can easily be used in low- and middle-income countries.
o Established in-house gold nanoparticle manufacturing to bring down the cost and be independent.
o Established network and obtained samples from different parts of India and Eastern Europe for in-house analytical validations. This will enable our products to be used in high TB burden countries.
Sputum sample to visual results in 3 hours