Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - BADGER (calScreener® – an innovative device for Bacterial Analysis and Diagnostics through Growth andEnergy-release in Real-time)

Teaser

Anti-microbial resistance was identified by the 2013 World Economic Forum as one of the greatest risks globally to human health. This conclusion was further emphasized from the Davos meeting: The Global Risk Report 2016, where the Spread of Infectious Disease was ranked as one...

Summary

Anti-microbial resistance was identified by the 2013 World Economic Forum as one of the greatest risks globally to human health. This conclusion was further emphasized from the Davos meeting: The Global Risk Report 2016, where the Spread of Infectious Disease was ranked as one of the top highest risks with the highest impact for humankind. When infections can no longer be treated by first-line antibiotics, more expensive medicines must be used. A longer duration of illness and treatment, often in hospitals, increases health care costs as well as the economic burden on families and societies.
Antibiotic resistance is putting the achievements of modern medicine at risk. Organ transplantations, chemotherapy, and surgeries become much more dangerous without effective antibiotics for the prevention and treatment of infections.

• Antibiotic resistance is one of the biggest threats to global health, food security, and development today.
• Antibiotic resistance can affect anyone, of any age, in any country, at any time.
• Antibiotic resistance occurs naturally, but misuse of antibiotics in humans and animals is accelerating the process.
• A growing number of infections – such as pneumonia, tuberculosis, and gonorrhea – are becoming harder to treat as the antibiotics used to treat them become less active.
• Antibiotic resistance leads to longer hospital stays, higher medical costs, and increased mortality.

To combat AMR, a multi-prong approach is needed, with actions including;

• A massive global public awareness campaign
• Improve hygiene and prevent the spread of infection
• Reduce unnecessary use of antimicrobials in agriculture and their dissemination into the environment
• Improve global surveillance of drug resistance and antimicrobial consumption in humans and animals
• Promote new, rapid diagnostics to cut unnecessary use of antibiotics
• Better incentives to encourage investment in new medicines and improving existing ones

To prevent and control the spread of antibiotic resistance, the health industry can:
Invest in research and development of new antibiotics, vaccines, diagnostics and other tools.

The technology and application development performed by Symcel Sverige AB has emerged as a potential new player for in vitro diagnostic use in the field of bacterial detection and antimicrobial resistance determination.

Diagnostic tools for bacterial infections and antimicrobial susceptibility testing are still in need of development with a focus on faster detection times, higher flexibility regarding the selection of antibiotics to be tested, and the possibility to detect bacterial activity in a range of different clinical samples. Todays ´technology is mostly based on the same principles of growth and detection as a century ago. Recent efforts to base the diagnosis on molecular probes has emerged but not fully delivered on the promise to become a widespread technology.

The overall objective of this study has been to establish the specific fields within in vitro diagnostics where the SymCel technology has the best fit and a possible impact as a novel tool for bacterial activity detection and antimicrobial resistance determination.

Work performed

The Horizon 2020 phase 1 report for the project BADGER (729076) has focused on finding the field in the market where our technology can have the largest impact and reach a large user base, where the need for novel bacterial detection technologies are high. The report covers the description of the medical problem at hand and the potential solution and a description of the key activity areas needed to validate the novel technology against other technologies as well as regulatory demands. The business model for entering the in vitro diagnostic market in the select market is further described. The BADGER report also covers a freedom to operate survey of Intellectual property filings.

The MBD method came in the 60’s, i.e. more than 50 years ago and is complimented with agar plating, which is some 140 years old. Methods that are unanimously regarded as completely outdated in today’s global world with ever increasing AMR.
We have discovered an urgent need for novel methods, and we have already started collaborating with Key Opinion Leaders, who share our view.
We aim to establish IMC as a surrogate method to BMD and augment the speed and accuracy of actionable information for the medical profession significantly and at the same time provide health organizations lower burden for both the society as well as of course for the individual patient.
We intend to engage several leading European institutes and US counterparts to validate our system for both colistin and meropenem resistance, two very important antibiotics that are becoming less and less effective in Europe as well as throughout the world.
The collaborators will provide a range of representative isolates from affected patients, add valuable expertise and experiences combined complimentary data validating IMC as a surrogate.

Our conclusion from this Phase 1 Study is that while Device Related Infections could offer an attractive opportunity for Symcel, we have found that Anti-Microbial Susceptibility Testing, for Minimal Inhibitory Concentration determinations of Sepsis-causing bacteria, in clinical settings is far more promising for us as the first choice for market penetration. One of the key reasons is the size of the sepsis market and our key feature of delivering speed and quality of answer that is actionable for the doctor at the bedside.

Final results

Some 700 000 people are dying every year as a result of antibiotic-resistant bacteria, and are estimated to grow to 10 000 000 deaths every year in only a few decades, with a cumulative 100 trillion USD of economic output at risk. We intend to work with sepsis indication as the first step to introduce and validate our technology, but plan to apply it for several other bacterial infections. This funding will allow us to grow Symcel to become a world leader in microbiological diagnostics, generating 1000’s of employees and saving millions of lives.

Last but not least; in only 3 years time the WHO has the following demand and vision that the rich countries must lead the way to make:
“It mandatory that by 2020 the prescription of antibiotics will need to be informed by data and testing technology wherever available and effective in informing the doctor\'s judgment to prescribe”.
This is a huge game changer for both patients and health care providers that no antibiotics can be prescribed without solid diagnostic data. Symcel AB with its unique and new technology will make this happen for the benefit of mankind and future generations.