Kfir Oved, chairman, co-founder and CTO of MeMed Diagnostics, writes about the development of its new technology aiming to combat antibiotic misuse and antimicrobial resistance (AMR).
Antibiotic misuse and the resulting global health challenge of antimicrobial resistance (AMR) has been around for decades. Unfortunately, despite numerous new technologies having been introduced to the market over the last few decades, we have not achieved a significant impact on this core problem. The first step in trying to solve this problem is to ask why state of the art technologies, developed by great teams, have failed to make a change in the rates and spectrum of antibiotic misuse and AMR?
The clinical dilemma that faces physicians when a patient presents with a fever is seemingly simple: to treat or not to treat with antibiotics? The challenge arises because bacterial and viral infections are often clinically indistinguishable, and physicians may feel there is often little choice but to prescribe an antibiotic because of the lack of clarity about the disease aetiology.
Numerous pioneering technologies have been developed in recent decades including multiplex PCR, rapid culture systems, rapid testing, and single biomarker analysis, all with the aim of helping physicians identify the pathogen and help guide treatment.
In order to create a real game change in antibiotic prescription habits, any technology must fulfil a list of requirements including:
- Accuracy of the test (>90%)
- Short time to results (minutes)
- Solution for inaccessible infection sites
- Inert to the presence of the natural flora
- Robust to rapidly evolving pathogens
- Accessibility at the point of need
- Cost-effective
- Easy to use
While many of the newer technologies improved on one or more of these aspects, no single technology has ticked every box, and have not made a significant impact on antibiotic misuse.
To find a solution, we went back to basics.
What is the problem?
To treat or not to treat with antibiotics.
What did we look for?
A way to distinguish between bacterial and viral infections that meet the requirements above.
How did we do this?
We utilised a very sensitive and accurate system that was crafted by nature: our immune system.
What did we discover?
The immune system responds differently to bacterial and viral infections, but there is no single biomarker that gives us this information accurately enough. Using a large-scale discovery process, we have identified the relationship between a key group of biomarkers: TRAIL, IP-10 and CRP, that decodes the host’s immune response to the source of infection.
If we go through the above list, this approach ticks all the boxes. A multiparametric signature that captures the immune response during infection was shown to be highly accurate in numerous double-blinded, multi-centre clinical studies (>90% sensitivity and specificity), testing using immunoassays can be done in minutes, there is no need to access the infection site, and the immune system is robust to the presence of colonisers that are part of the natural flora and to detection of emerging pathogens. The combination of our three-protein signature and proprietary algorithm is the MeMed BV test.
After defining what should be measured, we asked how we measure it? This impacts on time to results, ease of use, access at the point of care and cost-effectiveness. For this purpose, we developed a miniaturised immunoassay platform based on magnetic beads and chemiluminescence – the MeMed Key platform – which can run the BV test in 15 minutes.
Both platforms were awarded CE mark clearance, allowing physicians to distinguish between bacterial and viral infections and confidently rule out the unnecessary prescribing of antibiotics.
Our aim was to tackle antibiotic misuse by developing a diagnostic solution that distinguishes between bacterial and viral infection with central lab precision at the point of need. Data from more than 15,000 patients shows we have done this.
The next stage of our journey will be to utilise this approach to provide physicians with new, clinically relevant information based on our body’s response to diseases and injury.
