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insights from industrySanti Dominguez & Michael GrazCEO & Acting CEOImspex Diagnostics & Imspex Medical

In this interview, News-Medical talks to Santi Dominguez and Michael Graz, CEOs at
Imspex Diagnostics and Imspex Medical respectively, about the role breath analysis has to play in healthcare and diagnosis.

What is breath analysis and where does it fit in the spectrum of detection and diagnosis technologies for medical applications?

Santi Dominguez: Breath analysis has many applications and can be a community-deployable, point-of-care, completely non-invasive way of identifying and controlling many potential health concerns.

It also allows for early detection that will save resources and cost in treatments. This is important because our health services at the moment are mainly focused on diagnosis post-symptom onset and, hydrochlorothiazide use typically, when the symptoms appear, the situation is already quite serious, which means that any interventions will need to be more significant.

Breath analysis has the potential to be deployed much more widely in the community because it is non-invasive and it is extremely affordable. It could be used for a general state of health check-up on a regular basis, and that would potentially allow screening for the onset of many more serious diseases.

This would enable them to be picked up early and addressed at a stage when addressing them is much cheaper and effective than it would be if we did it later on in the process.

Michael Graz: Breath analysis can be used in a variety of ways. Volatiles that are exhaled can be used to explain physiological processes. Alternately, breath can be captured, distilled and biosensors used to detect an analyte (for example, a binary agent representing only one specific entity, an antibody or a protein that indicates the presence of a disease).

Exhaled volatiles give a breakdown of a body’s metabolism in its entirety and therefore paint a ‘whole body picture.’ Knowledge of a healthy or ‘non-perturbed’ space, in turn, allows perturbances to be identified (e.g., indicating infections, burnout, onset of non-transmissible diseases such as diabetes, Alzheimer’s Disease and cancer).

What is missing is large enough datasets to be able to make these decisions. Breath analysis would make diagnosis and treatment a lot more personalized and less of a ‘shotgun approach.’

Breath analysis can reduce the cost of diagnosis by reducing the number of samples that need to be processed by centralized laboratories and allowing them to become more focused on what they test for.

Breath analysis would improve the patient’s experience of sample taking by virtue of the sample taking procedure only requiring a patient to blow into a mouthpiece, followed by results being available quickly.

This would give an indication as to whether further testing is necessary and would not take away from existing specific diagnostic measures (such as a full blood count) to be used as required. Diagnosis for tuberculosis is one such application that would benefit from breath analysis as part of the diagnostic toolkit.

But one big factor would need to be overcome for this to happen. Treating physicians need to embrace the technology. Technology on its own is never going to do this by itself; it needs to be used. It must always be used as one of the tools that are being used by a physician in treating their patient. It is meant to support, not replace that process.

Breath analysis is likely to be the sole diagnostic in some cases. This depends on the application. In other cases, it will steer the treatment pathway. In the future, this may well come down to personalized diagnostics.

Why is breath analysis finding traction now in healthcare?

Santi Dominguez: In part, it is because we need these early detection and point-of-care technologies because we cannot afford to allow the population to progress down disease pathways to a point where they need very significant interventions and where they are going to take up a lot of resources. Breath analysis fits perfectly within this.

Michael Graz: I think it is because there is a need to develop new rapid technologies that are completely non-invasive and will have broad cultural appeal.

It is all being driven through the current pandemic. If the pandemic was not happening at the moment, I do not think we would see this rapid development, not only of breath tests but of technology as a whole.

Breath testing is starting to be seen as an application because it is non-invasive, and because of the fact that from a single sample, you can identify a lot of different things, not just a specific disease, but multiple diseases could be detected provided that your instrument is set up to do that.

That has been getting traction over the last few years, in part because Ray Kurzweil from Google foresees a future where a person breathes into their bathroom mirror, and it tells them about their state of health.

On the basis of the rapidity with which breath testing is now developing, you are likely going to be able to have a device that is small enough to fit in your house, that within a reasonable period will be able to give you an indication of your state of health by 2040-2050.

In your opinion, what usability features make breath analysis a preferred method for detecting and/or diagnosing disease conditions?

Santi Dominguez: First of all, I think the fact that it is completely non-invasive. We have many different diagnostic systems, and with COVID, we are seeing a number of these. In the past, for example, there was blood for analysis, urine analysis, and now swabs at the back of the throat, or even anal swabs, as we are seeing in China for COVID.

I think that non-invasiveness is very important. A lot of people may not be happy even with the less invasive of these, such as the back of the throat or nose swabs.

In many cases, we are dealing with children, which is a challenge because it is much harder for young children to do this kind of test. We also have religious or cultural considerations. There are religions or cultures in which that kind of invasive intervention is not really welcome. These make non-invasiveness the most important factor.

Secondly, breath analysis does not need consumables, so it is extremely sustainable from that point of view. There is no waste to speak of, other than the mouthpieces, which are fully recyclable.

Sustainability is a very big challenge in our society nowadays. The lack of consumables needed for breath analysis has a primary sustainability impact as well as a second impact which is the lack of supply chain.

We have seen, for example, with the Coronavirus pandemic how the supply chain for the consumables for many of these diagnostics can be a real problem when they are needed at a large scale globally.

Breath just relies on very easy-to-manufacture mouthpieces, which can be transported in very large amounts by traditional transport methods in traditional standard conditions of room temperature and just normal packaging. This is a huge advantage against other systems that may have much more complex logistics.

Another feature is its rapidity: the results are pretty immediate. There is no need to culture or to grow media; the result comes from the breath. With breath, you are getting a culture that has been cultured in a biological system, which is the human that you are diagnosing or looking at.

The result from that perspective is very immediate, particularly in the community. When we have a challenge getting people to diagnosis and screening locations, the fact that we can give a result immediately really increases the chances that we will be able to treat.

Often, if we have to get people in for diagnostics and the treatment comes later, that requires a second visit which is not always possible or convenient and which many people skip. It is beneficial to have it all at the same place at the same time.

Portability is also a factor. Breath analysis is ideal for screening in hospitals and GP clinics but can be done in the community; we can easily transport the systems, and they can be deployed anywhere where they are needed. In light of COVID, this would be potentially very significant.

Breath analysis could also be mobile. There is no reason why a breath analysis system could not be situated on an ambulance or some kind of mobile diagnostic unit that drives around the community.

Michael Graz: For me, the first feature is that breathing is something we naturally do, and unless you have a very significant pulmonary defect, you will be able to produce a deep breath which should have sufficient markers in it for the diagnosis to be relevant.

The second feature is you do not have to offer up a sample of bodily fluid, so you have quite a lot of opportunity to simplify the process and take away some of the stigmas associated with giving samples.

Another factor is, at least for early screening for things like cancer, you do not need an X-ray or a big machine. From a usability perspective, you do not need an entire hospital suite or a specialist that can draw blood or take some bodily fluid; it can be administered by someone with the correct background, meaning healthcare professionals can be freed up.

Ultimately, diagnosis is still only one of the many factors your physician will take into account to make a diagnosis on the disease that you have. But it can be very significant that if certain parameters are out of kilter, they can send you very rapidly for follow-up.

How widespread is breath analysis use in medical applications?

Santi Dominguez: At the moment, it is not very widespread. I think it is most adopted in the control of dosage of anesthetics in surgical interventions, where it is used to control for a substance called propofol which is the main constituent of the anesthetic. Breath analysis is therefore used to keep propofol to both safe and effective levels.

There is a lot of basic or anecdotal evidence on its use, for example, using dogs to diagnose cancer in Japan. However, breath analysis as an analytical technique has not been deployed to this point.

This is where Imspex is in a unique position because, as far as we know, we are the only company to have deployed breath analysis significantly for a diagnostic kind of application.

Micheal Graz: I can tell you about current non-medical applications, but breath analysis as such is not really used as a diagnostic tool at all. It is used more in rehabilitation and sports to measure oxygen, carbon dioxide and nitrogen, not a broad spectrum of volatiles.

In these settings, you are looking for people’s ability to use oxygen or absorb sufficient carbon dioxide for cardiovascular rehabilitation or training for an athlete. Beyond that, I have not seen it used.

What three words would you say best describe what drives Imspex Medical as an up-and-coming company?

Santi Dominguez: I would probably say ‘point-of-need.’ We are very much about delivering diagnostics where they are needed and they can have the maximum impact.

Michael Graz: People, passion, technology.

It is by people, for people, with a direct emphasis on ‘the people.’ It is driven by people who are incredibly passionate about what they do. At the end of the day, it is all based on cutting-edge technology.

Where can people find out more?

More details are available on Imspex Medical’s website at www.imspexmedical.com

About Santi Dominguez

Santi Dominguez is CEO of Imspex Diagnostics Ltd. As a serial technology entrepreneur and investor he has founded, overseen the growth of analytical chemistry software and ecommerce companies to revenues in excess of seven figures and exited or partially exited these companies.

Santi co-founded Imspex Diagnostics Ltd in 2011 as an analytical company with cutting edge detection technology. He has successfully overseen and completed three fundraising rounds and continues to manage expansion of the company’s technology to medical contexts requiring non-invasive point-of-need detection and diagnosis capabilities.

Being part of the development of technology that improves the length and quality of life for people continues to sit high on Santi’s list of career priorities.

About Dr. Michael Graz

Dr. Michael Graz is Acting CEO of Imspex Medical. His dual PhDs in cell biology from the University of the Witwatersrand and in pharmaceutical chemistry from the University of Port Elizabeth have formed the basis for a career that has taken in academic roles, consultancy positions, interim management roles and entrepreneurial ventures across four continents.

These have included CEO and CSO roles in R&D biotechnology-,  drug delivery medical technology-and in vitro diagnostic device SMEs, respectively.

Each opportunity to have been part of the engine that moves ground-breaking research from an idea to a solution that is used by end users features high on Michael’s list of worthwhile career achievements.

About Imspex Medical

Imspex Medical brings the combined power of gas chromatography and Ion Mobility Spectrometry to bear on volatile organic compound analysis as a non-invasive, ultra-sensitive, rapid and reliable way of detecting and diagnosing a wide range of infectious and inflammatory disease states at point-of-need.

At Imspex Medical, we know the value of identifying disease states early. Our objective is to make regular, non-invasive volatile organic compound screening accessible and affordable to maximise individuals’ health, wellbeing and opportunities for economic prosperity.

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