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QuickMIC™ - an ultra-rapid diagnostic system for Antibiotic Susceptibility Testing (AST)

Periodic Reporting for period 1 - QuickMIC (QuickMIC™ - an ultra-rapid diagnostic system for Antibiotic Susceptibility Testing (AST))

Reporting period: 2018-04-01 to 2018-09-30

The WHO stated in 2014 that “Without urgent action, the world is headed for a ‘post-antibiotic era’ in which common infections and minor injuries which have been treatable for decades can once again kill, the benefits of advanced medical treatments such as chemotherapy and major surgery will be lost ”. Antimicrobial resistance (AMR) is considered to be one of the biggest threats to global health . Without the proper action on AMR, the world GDP is projected to be 2 to 3.5% lower than it otherwise would be in 2050, implicating a EUR 100 trillion world GDP loss. The annual deaths attributable to AMR can reach 10 million persons compared to today’s low estimate of 700,000 persons.
Due to increasing AMR, infections like sepsis are becoming harder to treat as antibiotics become less effective.
Sepsis affects more people than lung, breast and prostate cancer combined. It is also connected to extremely high mortality rates, with a fatality case occurring every 3 seconds . The condition spreads quickly and affects multiple organs, often leading to septic shock. The severity of sepsis determines the clinical outcome. Studies have shown that death rates can reach 20% for sepsis, 50% for severe sepsis and up to 80% for septic shock .
A timely treatment with the appropriate antibiotic in sepsis is thus critical for the patients. However, in most European hospitals, antibiotic susceptibility testing (AST) still follows the methods (disk diffusion and Etest) that are based on discoveries back from the 1860s. Their main disadvantage is the long time to diagnosis – it takes 24-48 hours to deliver results. Doctors will always treat sepsis empirically since every minute until possible appropriate treatment has effect on patient survival. But with globally increasing AMR, empirical treatment is failing more and more often. Important is that the sooner the antibiotic treatment can be adjusted to match the AST results, the higher chance of survival for the patient and the shorter the hospital stay.
Given the limitations of the established diagnostic tools, the medical community advocates a pressing need for improved diagnostic technologies that would decrease the use of broad-spectrum antibiotics and enable more timely tailor-made treatments. From the business perspective, there is a significant opportunity for growth in being able to satisfy this demand. The global sepsis diagnostic market is expected to reach EUR 536 million by 2023, at CAGR of 9.1% between 2018 and 2023.
Task 1: Clinical feasibility
Task 1.1. Analytical Performance Evaluation Plan (system verification tests to be conducted in-house)
Task 1.2 Clinical Performance Evaluation Plan (validation tests to be conducted at clinical end-user sites.
Task 2 – Market feasibility
Task 2.1.Pricing – analyse which price level of instrument and consumables is seen as acceptable by the decision-makers on the key geographical markets (Europe and the US)
Task 2.2. Detailed user need mapping – perform a detailed analysis of the users’ needs.
Task 2.3. Positioning against competitors – develop a better understanding of the competitive landscape as well as existing market barriers.
Task 2.4. Partnerships – identify clinical partners for the clinical validation part of the development
Task 2.5. Risk analysis – update risk analysis for the product
Task 2.6. Capital requirements – define capital requirements to move the business forward.
Task 3: Business Plan Development and Formulation
Task 3.1. Dissemination and communication – to reach key stakeholders with the information about QuickMIC™ through participation in relevant events and dedicated communication activities; to approach and acquire new investors,
Task 3.2. Business plan formulation – synthesis of the results and business plan formulation. In this task, we aim to benefit from the coaching services offered within SME Instrument, Phase 1.
The project was found to be promising and will be continued.
The novelty of QuickMIC™ lies in its ability to reduce AST time to only two hours. This is achieved by:
• Optimized microfluidics: Controlled fluid flow allows for antibiotic gradients to be established rapidly and maintained stable over long time. By letting bacteria grow in a microfluidic cell culture system the antibiotic environment surrounding the bacteria is formed rapidly and is very well-controlled, which contributes to rapid bacteria responses and hence shorter analysis times.
• Continuous imaging and optimized algorithms: Real-time imaging and optimized algorithms for analysing the single bacteria colonies in the continuously captured images contributes to short analysis times.
Moreover, two hours are close to the biological limit for AST as the bacteria requires time to grow and respond to the antibiotic.
In clinical laboratories, blood samples are initially put in a blood culture to identify positive signs of bacterial growth. An incubator ensures favourable conditions to cultivate bacteria and triggers an alarm as soon as signs of positive bacterial growth occur. Today’s incubators on the market trigger the alarm at a level of 106–107 cfu/ml (colony forming units/ml). Currently, QuickMIC™ has a lower detection limit in the range of 104 cfu/ml, i.e. a very much lower bacterial concentration. This opens up for even shorter total turn-around times in the laboratory, since the QuickMIC system could use blood samples that have incubated over a much shorter time.