Special Report: Decoding the immune system

MeMed’s founders, Dr Eran Eden (CEO, left) and Dr Kfir Oved (CTO, right)

MeMed’s founders, Dr Eran Eden (CEO, left) and Dr Kfir Oved (CTO, right)

To treat or not to treat with antibiotics? Disruptive technology from award-winning MeMed can help doctors make the right call.

Daily dilemma, global impact
It is often difficult for a clinician to decide if a feverish patient is suffering from a bacterial or viral infection, as the clinical symptoms can be similar. This seemingly simple problem leads to antibiotic overuse – the prescription of antibiotics to patients with viral infections, for which the drug is unhelpful. Indeed, roughly 50% of antibiotic prescriptions are estimated to be inappropriate,1 and this imprudent use is contributing to one of the greatest healthcare challenges of our times, namely the spread of bacteria that are resistant to antibiotics. It is estimated that by 2050, ten million lives a year and a cumulative USD 100 trillion (~€94.2tr) of economic output are at risk due to the rise of drug-resistant infections if proactive solutions are not found to slow down the rise of drug resistance.

Infectious disease detective
Rapid, accurate and actionable diagnostic tools are an important part of the solution because they can aid physicians in making better informed treatment decisions. For the past six years, the MeMed team has been collaborating with leading clinicians and scientists from across Europe and around the world to develop and validate a novel approach for distinguishing between bacterial and viral infections. Unlike most traditional diagnostics that aim to identify the pathogen, this approach builds on an exquisitely informative system crafted by Nature – the human immune system. The human immune system has evolved for millions of years to respond differentially to viruses and bacteria and activate distinctive response pathways. MeMed has identified key players in these pathways, called biomarkers, which circulate in the blood and can serve as characteristic ‘immunological fingerprints’ for bacterial, viral or non-infectious diseases. This decoding of the immune system has enabled MeMed to develop new rapid blood tests that give the clinician information about the patient’s health status. The company’s first product, ImmunoXpertTM, accurately and rapidly detects if a patient has a bacterial or viral infection, information that empowers physicians to make better informed antibiotic treatment decisions.

Award-winning technology
MeMed, an Israel-based company founded in 2009, is a European innovation champion and the winner of multiple awards from the European Commission. Currently, a €3m award through phase II of Horizon 2020’s Small and Medium-sized Enterprise (SME) Instrument is being used to support the development of MeMed’s second-generation product, ImmunoPoC™, which will enable rapid (within minutes) measurement of a patient’s immune response to infection at the point of care. In addition, the SME award is financing a multi-centre prospective clinical study, which represents a collaboration between leading research centres at the Royal Free London NHS Foundation Trust (UK), Hannover Medical School (Germany), and Rambam Health Care Campus (Israel). Earlier this year, MeMed secured an additional €2.3m through the Horizon 2020 Fast Track to Innovation Pilot to support AutoPilot-Dx, an international consortium with members from leading medical centres and industry. The overarching goal of the consortium is to widen deployment of ImmunoXpert in Europe. Furthermore, MeMed is a leading partner in the FP7 (Seventh Framework Programme) Tailored-Treatment consortium, which studies patient-pathogen interactions, together with collaborators from the Netherlands, Spain, Israel and Sweden.

“We value greatly the continuous vote of confidence from the European Commission,” said Eran Eden, PhD, CEO of MeMed. “These awards allow us to strengthen our collaborations with clinical key opinion leaders and industry partners in Europe, accelerate our development efforts and enable us to help a wider range of patients sooner.”

Kfir Oved, PhD/MD, CTO of MeMed, added: “Antibiotic misuse is a pressing public health concern, with devastating healthcare and economic consequences. We are proud to be part of the solution. We are well positioned in this arena, being ahead of competition, but we’re a humble company and always try to see what others are doing to learn from them. Our focus is to build a great tool with extensive clinical evidence behind it.”

Solid clinical evidence
MeMed considers solid clinical evidence the cornerstone for introducing its innovative technology into the market and in the past few years has been performing a series of large multi-centre clinical studies enrolling over 10,000 patients. Results of the first clinical study, called the ‘Curiosity’ study, enrolling 1,002 patients were already published in PLoS ONE2 and Journal of Infection.3 In this study ImmunoXpert accurately distinguished between bacterial and viral infections with a sensitivity and specificity greater than 90%. The assay was validated in a diverse group of paediatric and adult patients at different time points after the onset of symptoms and across 56 different pathogen species. ImmunoXpert performed robustly on all sub-groups studied, outperforming routine biomarker and laboratory tests. Two additional external multi-centre blinded-validation studies were completed this year and results are expected in early 2017.

Continuous investment in innovative R&D
MeMed is investing significant resources in developing a line of novel products that decode the immune response with the aim of improving the management of patients with acute infections and inflammatory disorders. MeMed’s state-of-the-art manufacturing and R&D facilities are located in one of the largest high-tech parks in northern Israel. The company’s activity and processes are under ISO 9001 and the ISO 13485 quality system. MeMed’s interdisciplinary team brings decades of experience and a proven track record in diverse fields, including molecular immunology, informatics, clinical infectious diseases, and in vitro diagnostics. MeMed’s ImmunoXpert test is CE marked and approved for clinical use in the EU, Switzerland and Israel, with pilot distribution at select excellence centres.

References
1 The Review on Antimicrobial Resistance at https://amr-review.org/
2 Oved K. et al. PLoS ONE 10, e0120012 (2015)
3 Eden E. et al. J. Infect. (2016). doi:10.1016/j.jinf.2016.05.002

Asi Cohen-Dotan, PhD
Global Incentives Manager
MeMed Diagnostics Ltd

+972 4 850 0302
asi.cohen@me-med.com
www.me-med.com