Redefining the Set of Solutions for Antibiotics Misuse Using Host Response-Based Diagnostics

Tom Cahoon:
Welcome to this podcast from Cambridge Innovation Institute about the upcoming Molecular Diagnostics Europe event running from April 10th through the 13th, 2017 in Lisbon, Portugal. I'm Tom Cahoon, market research analyst and administrative assistant. I'm pleased to have the opportunity to speak with Kfir Oved, co-founder and CTO of MeMed to speak with us about his upcoming talk A Set of Solutions for Antibiotics Misuse Using Host Response Based Diagnostics. He will be giving a talk at the Advanced Diagnostics for Infectious Disease track running from April 11th through 12th at the Molecular Diagnostic events. Kfir, thank you for joining us.

Kfir Oved:
I'm privileged. Thank you for inviting me.

Tom Cahoon:
Can you outline what you consider to be some of the greatest obstacles to controlling antibiotic misuse?

Kfir Oved:
What I can try to describe is basically what we have identified as the biggest hurdles in antibiotics misuse. There are three pillars for this problem. The first one is the issue of time. There are a lot of available solutions out there today, but many of them still takes hours and even days, including, for example, cultures, but also, the PCRs and the multiplex PCRs still take some time for the vast majority of settings. The problem is an acute infectious disease is a disease that usually is a very acute setting type of disease and decisions are being made within minutes, so there is one gap over there.

The second one is the issue of pathogen inaccessibility. I think it's pretty known to everyone that if you have a sore throat, you can just go to the CVS and buy a rapid strep test, test yourself and get the result within five to ten minutes, but that's only possible because the pathogen is accessible. Cases like, for example, pneumonia, sinusitis, otitis media, fever without source and other types of infections do not enable us to effectively sample the pathogen and therefor about one third to one fourth of the patients actually can not be served by the currently available solutions at all and are a major source, especially otitis media, for antibiotics they overuse.

The third element, which is also something that is extensively explored in the last decade is the issue of colonization and natural flora. The more sensitive the tools we develop, the more false positive and false negative results we get. Just as an example, the mere fact that you have identified streptococcus pneumonia in the nasal pharynx of a child with fever does not necessarily mean this is the disease causing agent. Those false positives are also a major source for both confusion, overuse and underuse of antibiotics in the acute infected patient.

Tom Cahoon:
Can you describe your product?

Kfir Oved:
Sure. I think that's a natural continuation to the previous question. Eight years ago when we went out to try to find a solution, a rapid solution that would enable physicians to make better antibiotics decision making, we envisioned those three problems as time, a pathogen inaccessibility and sensitivity to the natural flora. We decided to go on a slightly different route than others and try to gather the forces of our immune system, an amazingly effective protection system that is built within each and every one of us. What we actually do is listen to the immune response of a patient and by doing that, measure its immune response, integrate using that algorithms and translate that into actual diagnostics.

We went through a process of screening over 600 different proteins is a quantitative measure. This is arguably the largest quantitative host response prodromic study every to be conducted in infectious diseases. We were able to identify the set of three soluble proteins that we can quantitatively measure in a standard blood sample using standard immuno assay. It takes us around 10 to 15 minutes to do this measurement. We integrate them using a proprietary algorithm and gets a score ranging from zero to 100. The lower third of this scale, zero to 35 indicates a viral infection. 35 to 65 is an indeterminate area. 65 to 100 is a bacterial infection. Now we were able to show that using this scale we can basically classify viral and bacterial infections from multiple sources, children and adults, respiratory tract infections, fever without source and many, many other types of infection with sensitivity and specificity of over 90% as was validated in multiple clinical studies.

Tom Cahoon:
What is unique about your approach?

Kfir Oved:
There is no silver bullet for this problem. This approach can assist a lot to physicians in their current decision making. I do not think that there is a single answer to this problem and this is definitely going to be a, we see if as a kind of triage test that can be performed to the vast majority of acute infectious patients. They make better antibiotics decision making. It will need to be integrated together with other potential tests, especially in the more critically ill and severely ill type of patients.

Tom Cahoon:
What advice do you have for people introducing new products in the clinical setting?

Kfir Oved:
To be really honest, to develop a tool for clinical setting or for clinical practice was, and still is, a humbling experience but if I need to narrow that down into two major points, that would be clinical utility and health economics. If someone wants to introduce a new technology or a new product to the clinic, it needs to show A, accuracy. That's a prerequisite. Accuracy is not good enough. Today you also need to show that you can change the physician's behavior. You can really impact the physician in the decision making process and you can basically show that you improve the patient management. That would be one [anvil 00:05:24] and the way over there is just creating a lot of data. High quality, massive amount of clinical validation, both using clinical studies, randomized control trials and others that would be one pillar for this answer.

The second point would be health economics. We are living today in a budget constrained environment in the healthcare system and there are a lot of cool technologies out there. One of the biggest challenges for a new technology is basically to show that you can not only improve the management of the patient but also not increase the cost of treating this patient. Especially in the acute infectious disease arena where the number of patients are hundreds of millions and sometimes billions, it really depends on how you count, annually, worldwide. The potential impact of high cost diagnostics, for example, can be tremendously high on the system. There is a challenge on how to balance between the value you can bring from a health economics perspective and how much you can bill for such a technology.

Tom Cahoon:
What are some of the most exciting new developments emerging for AMR?

Kfir Oved:
Maybe I'm a bit subjective here, but I would say that one of the most thrilling things that happens these days in AMR is actually using the host response. I think that the host response, there is huge potential for us as humanity, not only to solve the issue of antibiotics misuse but also other clinical problems. I think that over there, we are at the end of the first decade of host response based diagnostics and host response tools and the future looks really, really bright for this topic.

Other advancements that have been shown the last few years were to use [inaudible 00:07:03] genomics and sequencing for exploring antibiotics resistance for being able to identify a potential targets and for being able to basically dissect or identify the flow of antibiotics resistance worldwide.

Tom Cahoon:
What are you hoping to learn at this conference?

Kfir Oved:
I'm really hoping to come and to listen to smart people coming with A, new ideas and new technologies, new perspectives. To be able to have some dialog with some of those different views. Also, maybe to join an integrative approach where more than one attitude can be joined together to a policy or into a strategy that can assist us fighting antibiotics resistance, which is basically one of the biggest healthcare challenges of our days and maybe one of those problems that we really, really need to solve to leave our children a better place to live in.

Tom Cahoon:
Kfir, thank you for your time and insights today.

Kfir Oved:
It was my pleasure. Thank you very much for the opportunity.

Tom Cahoon:
That was Kfir Oved, PhD. Co-founder and CTO at MeMed. He'll be speaking in the Advanced Diagnostics for Infectious Disease Track at the upcoming Molecular Diagnostics Europe event, running from April 10th through the 13th in Lisbon, Portugal. If you'd like to hear him in person, go to www.moleculardxeurope.com for registration information and enter the key code podcast.

I'm Tom Cahoon. Thank you for listening.