Liquid biopsies will be a game-changer for cancer patients. As well as being less intrusive than tissue biopsies and virtually risk-free, they are cheaper and lead to faster results. It’s no exaggeration to say their widespread use could save many lives. In this article, we speak to Damien Lapray, Co-Founder of Hedera Dx, to dive into the world of liquid biopsies for cancer patients.

A fragmented market

Damien explains that liquid biopsies today are mostly used for what is called tumour profiling: ‘You want to assess the molecular profile of a tumour, so you do a tissue biopsy or liquid biopsy. You analyse either tissue or blood, or sometimes both, to learn about the cancer type and the related therapies.’

The use of liquid biopsies is far from widespread – and varies hugely from country to country. In the US, their use is much more common than in Europe. There, private centralised laboratories receive blood samples, analyse them and send a report back to the clinician, who then chooses appropriate treatment for the patient.

In Europe, it’s a different story. ‘The process here is decentralised. Each hospital does its own testing, meaning there is no homogenised process. It’s a very fragmented market,’ Damien comments. ‘Some countries – like France and Germany – are moving quickly, often because hospitals can choose how to use their budget. Then you have countries lagging behind, like Spain, Italy and the UK.’

Making liquid biopsies mainstream: a slow process

Given the advantages of liquid biopsies, it would make sense to use them routinely in European hospitals. This is not always the case at present, particularly when the tests involve next-generation sequencing (NGS), a cutting-edge technology used to detect genetic changes in cancer. Aside from a decentralised system, various other obstacles stand in the way. One is that many products on the market have produced poor-quality results until now: in the past, they have failed to detect what they should have found in patients’ blood. Understandably, this led to caution from doctors when it came to ordering these tests for patients.

This is where companies like Hedera Dx can play a vital role. ‘At Hedera Dx, we’ve developed an NGS liquid biopsy test that can integrate into hospital workflows and produce accurate and fast results from a blood draw,’ explains Damien.

The previous poor quality of tests was due to companies applying old methods to a new problem and a lack of regulation in the field. Since 2022, however, there has been a new regulatory framework in Europe called the In Vitro Diagnostic Medical Devices Regulation (IVDR). This stringent regulation requires compliance for all in-vitro tests, including those for liquid biopsies. ‘In the world of pharma, this kind of compliance is commonplace, but in genomics it’s been something of a Wild West until now,’ Damien notes. ‘Before, you could develop a test and self-certify it, which isn’t ideal as it leads to substandard products on the market. So this regulation isn’t a bad thing per se, but it does take time and money as you need to get your hands on many patient samples.’ Many more companies are now trying to develop IVDR-certified tests, but strict regulation has inevitably slowed their progress. To date, there is no decentralised IVDR-certified liquid biopsy test available on the market.

And it also hasn’t helped that, since the Russo-Ukrainian War, the market has slowed down. ‘Just three years ago, it was relatively easy to get funding,’ remembers Damien. ‘There was a lot of investment – and this is no longer the case. But I’m hopeful – people are talking about liquid biopsies a lot more. Backed by a strong market, the US is heavily investing in this area. In Europe, it’s more slow-going as investors are more risk averse but we are lucky to be well supported.’

All of this said, Damien is convinced progress will accelerate in the next few years – and start-ups like Hedera Dx will help by providing the agility and speed that larger corporations struggle to achieve: ‘Unlike a big company, we have only one focus – and that is liquid biopsy tests. We have the expertise but we’re also fast and nimble. The struggle for small companies like us is to make molecular pathology laboratories aware of who we are and how we can help. I’ve spent a lot of time talking to hundreds of hospitals around the world to build relationships and trust.’

A shift towards disease monitoring and early detection

Damien hopes to see liquid biopsies used at earlier stages of a patient’s journey, when the chances of successful treatment are much higher. Once it has been established that a patient has cancer, liquid biopsies could be used to monitor their condition. These tests can help detect whether there are still cancer cells in the patient’s body following surgery or radiotherapy – therefore needing further treatment – versus patients who are cured.

‘In some cases, a patient’s treatment stops working as the cancer starts to acquire resistance,’ says Damien.  ‘When the tumour mutates and resists treatment, a patient’s therapy should be changed. By taking blood samples at regular intervals, doctors could intervene at the right time.’ It isn’t possible to do this with tissue biopsies because they are invasive and have limited capacity to detect tiny amounts of cancer left in the body. Liquid biopsies are therefore perfectly suited to monitoring cancer at both early and more advanced stages.

Liquid biopsies could also be revolutionary for very early detection. ‘The technology is being developed and there’ll be huge progress over the next decade,’ Damien hopes. ‘It has massive potential. Imagine if, starting when you’re 30 or 40 years old, you could do a regular test that could catch cancer very early – when it can still potentially be cured. This could make a huge difference to patient outcomes. Take survival rates for breast cancer for instance: 99% of breast cancer patients survive when the cancer is caught very early, versus only 26% of patients when the disease is detected at a later stage.’

The more, the merrier

The path liquid biopsies will follow is fairly predictable. First, they will become more widely used in profiling. Then, they will be used for monitoring, and ultimately they will help with early detection. This is the path they are taking in the US, and although Europe lags behind, several companies are picking up the pace in developing these technologies.

Damien welcomes this flurry of activity in the field. ‘Sometimes it’s seen as a negative to have competitors,’ he says. ‘But I’m delighted. In fact, I don’t think of similar companies as competitors, as such. If we want to see innovation in the market, the more that companies focus on liquid biopsy tests, the better. We’ve got our work cut out for us.’