19 August 2018

Can we Find a Truly Non-Invasive Diagnostic Test?

By Eleanor Doolin By Eleanor Doolin

Everyone is always developing the next big thing in diagnostics. Whether it’s a blood test to identify a disease earlier than ever, or a point-of-care device that might save thousands of lives in a rural area, the whole market is constantly evolving.

Some diagnostic tests are more difficult to perform than others and might need a biopsy to identify a certain condition, or a blood test which is sent to a lab. Broadly speaking, these two examples would be classed as ‘invasive’ diagnostic procedures.

If we’re going to go for the dictionary definition (which we are) then invasive means

‘involving the introduction of instruments or other objects into the body or body cavities’.
That covers a lot of procedures taking place in every hospital around the world today.

As we move closer to a world of predictive, precision, medicine then it’s becoming more important than ever to reduce patient discomfort and improve efficiency in diagnostic procedures, which is why non-invasive testing is such a hot topic.

A new wave of companies are coming up with new ways of non-invasive diagnostic procedures. But can any test be truly non-invasive? I’ve picked a few companies doing some great things across the market to try and answer that question.

What I think makes this even more interesting is that all the technologies I’m featuring here are totally different – showing just how much innovation is taking place in this area.

Who's Making Moves into Non-Invasive Tests?

 

Easing us in to the non-invasive space is Oasis Diagnostics. They’re a company conducting research into collecting samples of saliva or oral fluid, which in vitro tests can subsequently be performed on.

Collecting saliva or ‘oral fluid’ is a far less intrusive process than that of blood, tissue or spinal fluid. It’s painless, fast and can be conducted anytime or anywhere without risk of infection.

Strictly speaking though, if we’re going to go with the dictionary definition of ‘invasive’ (which we are), even a swab could count as an instrument, so we’ll keep looking…

One company who think they may have cracked it with their attempt to replace the traditional blood test is Sonorapy. They specialise in acoustic detection technology which employs soundwaves to detect viruses by measuring unique sonic signatures. They then compare this to ‘normal’ ranges and deliver instant results.

In layman’s terms, they’re scanning cells with sound.

At the moment the test is still in the development stages and the test is carried out on a single blood sample, but in the future, could this be the first step towards a medical scanner straight out of science fiction?

Back onto the task at hand though – as the Sonorapy platform currently needs a blood sample they don’t tick the 100% non-invasive box just yet.

So if we aren’t at a point of using sound to diagnose patients, what about light?

Just a couple of months ago a young Ugandan inventor won the Royal Academy of Engineering’s Africa Prize for a device which detects signs of malaria by shining a beam of light onto the patient’s finger.

The Matibabu device doesn’t require a blood test or even trained professionals. It uses light to detect changes in the colour, shape and concentration of red blood cells, which are all affected by malaria. The device is currently undergoing regulatory assessment and approval and the company are looking to make commercial partnerships. 

 

Another non-invasive award-winner are Owlstone Medical, who recently picked up the UK’s most prestigious prize for engineering, the MacRobert Award. They use breath samples and have stated that their mission is to save 100,000 lives and $1.5B in healthcare costs globally.

They’re a company we’ve been excited about for some time – in fact my colleague Adam featured them in an article about the point of care space in February this year. Take a look at that here.

Their ‘breathalyzer for disease’ hopes to be able to diagnose cancer, infectious and inflammatory diseases. If they pull it off, they’ll deserve all the acclaim and awards they’ve been receiving, and there’s nothing invasive about giving a breath sample, right?

Well, maybe not. Shouldn’t a truly non-invasive test not even require you to leave your home or ‘invade’ your day in any way?

Sometimes even the mere presence of another person – even a medical professional – could be classed as an invasion of your time and space. So how do you get around that?

Well, you do it yourself.

When women go for a breast examination to stop breast cancer, they’re subjecting themselves to the ‘radiation exposure, discomfort and anxiety in exposing yourself to a third party’ that is associated with the process, according to medical advisor Dr Richard Kazynski.

Higia Technologies think that they could have identified an alternative. They’ve developed a wearable device which enables women of all ages to perform breast examinations in an effort to catch cancer earlier.  

The device, a bio-sensing bra insert called EVA, uses thermal sensing and AI to identify abnormal temperatures in the breast that can correlate to tumour growth. Testing indicates that the method could be even more successful than mammograms, which aren’t highly sensitive when it comes to detecting tumours in dense breast tissue.

Higia, EVA and CEO Julián Ríos Cantú have recently received a six-figure investment from the prestigious Silicon Valley seed investor Y Combinator – another endorsement of the product’s potential. 

Urine testing is the world’s second most frequently conducted diagnostic test. However, it’s a long and drawn out process to give a sample.

Currently, it involves leaving the house, travelling to a dedicated facility, collecting and handing over the sample who then processes the data. In a typical day, that’s pretty invasive.

Healthy.io say this method is inefficient and hinders the adoption of preventative care and precision medicine through the time it takes to give a sample. That’s why they’ve reinvented the whole process.

Their system allows you, the patient, to take and test your sample at home before taking a picture of the results with your smartphone. The results are added to your medical records immediately and your doctor is made aware.

Currently available in the UK and undergoing FDA approval in the US, Healthy.io’s testing service could be coming to your bathroom soon!

So Who Wins?

Depending on your perspective, either no one, or everyone. It’s impossible to compare such wildy different tests and come out with one that’s objectively more or less invasive than the others.

Instead, it looks like the whole market segment is winning. Whether using sound, breath, light or saliva as a sample, non-invasive diagnostics is an area companies are clamouring to get into, with competition breeding innovation and, ultimately, a better patient experience.

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Eleanor Doolin

Eleanor Doolin works as a Business Manager broadly within IVD but has previously spent time focusing specifically in clinical chemistry and oncology, plus advances in non-invasive diagnostic testing. She is always looking to connect with innovative individuals and organisations working in this area.

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