Q&A: discussing cancer blood testing tech with Volition – Verdict Medical Devices – Medical Device Network

]]]]]] Volitions CEO, Cameron Reynolds spoke to Medical Technology about the companys story so far and what sets their technology apart from others in development. Credit: Volition

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Epigenetics company Volition is hoping to carve new ground in the cancer diagnostics space. Through measuring tumour nucleosomes (a type of epigenetic structure) in the blood, it is creating a range of blood tests that can detect cancer from the earliest stages. The company says these tests will be simple, cost-effective and easy to use.

With clinical trials underway, the company is now focused on bringing its toolbox of diagnostic products to market. Volitions CEO, Cameron Reynolds spoke to Medical Technology about the companys story so far and what sets their technology apart from others in development.

Abi Millar (AM): Whats the story behind Volition? Can you tell me a bit about your path to getting where you are today?

Cameron Reynolds (CR): We started ago nearly ten years ago, in September 2010. Were still using the same technology platform as we were then a lot of companies chop and change, but weve always believed in epigenetics and see them as really important in cancer diagnosis.

We started with one original patent application, which was licensed to us from Chroma Therapeutics. We wanted to commercialise this basic concept of using nucleosomes (a type of epigenetic structure) for a marker for cancer detection, and eventually a number of other diseases as well. So we set up a subsidiary in Belgium, which we felt was a good value place to develop research, and raised just over a million euros. We also have offices in Texas, London and Singapore.

Our whole ethos has been to make low-cost, routine cancer diagnostics with an ELISA based format. The ELISA platform is 35 years old our chief scientific officer Jake Micallef has been working on this format his entire life, and hes a big believer in keeping it affordable.

We started with our original patent, which was histone modifications, and then we patented everything else we did along the way, so we have very strong intellectual property. We began with diagnostics for human cancers, starting with colorectal, and then adding in lung cancer and some other cancers where weve had some good results.

Around two and a half years ago, we expanded the staff and moved into a bigger facility in Belgium. We now have 35 people working there, attempting to create a robust, reliable stable platform to measure the tumour nucleosomes in circulation. We went public in 2015 on the New York Stock Exchange, since the capital markets are quite a good source of funding if you have something new and innovative.

Since then weve just been swimming in our own lane, developing our technology. Were in the process of launching a range of products over the next few years, and hopefully we can really do a good job with it.

AM: You are developing a range of blood tests for cancer diagnostics called Nu.Q, which has been described as an epigenetic toolbox. What is Nu.Q exactly? How does it work?

CR: We have several different ways of analysing the nucleosomes, ranging from a very simple microtitre plate-based ELISA format to a magnetic bead-based ELISA format. The new process were developing now, called Nu.Q Capture, involves capturing the nucleosomes on the machine, isolating them from the plasma, and conducting mass spectrometry analysis. This enables a greater concentration of nucleosomes.

Were using Nu.Q for our own purposes in cancer trials and other trials, and have also partnered with Texas A&M Veterinary School to find out whether our basic format could be useful in veterinary science too. Thats why we call Nu.Q a complete toolbox. Its a very robust reliable platform that can be used in all these different areas, and its a whole new way of analysing the epigenetic structures.

AM: What is different about this method, compared to other diagnostic assays for cancer?

CR: Since we started, there have been a lot of different cancer diagnostics in development, based on circulating tumour cells, DNA, exosomes, etcetera. But were still the only group ever to have looked at nucleosomes in circulation as a diagnostic.

We also have the ethos to keep it very affordable and easy to use. With a lot of companies its a complicated, expensive technology circulating DNA for instance requires a very large blood draw and quite expensive processes. Weve kept it simple, and we can do that because the markers were after are common in the blood and you can measure them with a simple ELISA format.

So theres always space for lots of different methods, but we think theres a very strong need for a low cost, reproducible reliable test that can be taken by huge numbers of people around the world as part of their normal medical work. That makes us unique not only in terms of the markers were after the nucleosomes but also in terms of the basic ethos. Weve spent the last two and half years fully optimising the platform itself so it can be robust, reproducible and reliable and accessible to any lab in the world.

AM: You currently have a number of clinical trials underway and presented some initial data at the 2020 ASCO Annual Meeting. What might the path to the clinic look like?

CR: We now have some markers that have shown very good efficacy in a range of cancers, but were also looking for differential markers between the different cancers. Were running some smaller trials for lung, colorectal and blood cancers some of the data was released at ASCO and now were putting together panels of those to get enough accuracy for a frontline test.

We also have some larger trials, like the early detection research network in the US, which will involve around 7,000-8,000 people. There are also some in Taiwan for lung and colorectal cancers, which will involve around 8,000-9,000 altogether.

So, weve got small and medium-sized trials along with some very large product trials. Thats on top of the trials we have in the veterinary space, as well as trials for things like Nu.Q Capture. Weve also had some very encouraging data in Covid-19, where were looking at prognostic outcomes.

Our assays are very low cost and easy to run with small amounts of blood, so we can run them in lots of different areas. There should be a lot of results coming through this year, next year and into 2022.

AM: What are your hopes for the future? What could the implications of your technology be further down the line?

CR: My hope is that our kits will enable much earlier diagnosis. That would really help to lower costs both in human terms and financially. If you get diagnosed early, you can survive it a lot longer of those diagnosed in stage 1, about 95% survive five years or more whereas its exactly the opposite if the cancer is found in stage 4. Thats obviously horrible for yourself and your family but its also a financial burden for health systems.

So hopefully it will have a very strong human impact on limiting the severity of the disease, as well as saving health systems and individuals money. This will make it affordable for healthcare systems in the developed and developing world, so we can hopefully save lives worldwide. And what we hope is that in five years, a large percentage of the worlds population who are either of age or at risk take our blood tests through routine blood work and we can do a lot of good in a lot of different areas.

AM: More generally, what do you expect the future of blood testing for cancer to look like?

CR: I certainly hope the other tests succeed, because particularly in markets like the US where there is an appetite for expensive tests, I think they could be very useful and some of them could be very accurate. So thats always a good thing, but what were providing is a routine, easy to use, lower cost alternative.

I think there are going to be things happening at both ends of the market, both at our end and also at the more complicated end of the market. A lot of it will be based on the epigenetics and not just the DNA the complete package of the epigenetics, the nucleosomes and the whole chromosome will make a big difference.

So, there are quite a few things in development that may work and I think theres going to be a real revolution in cancer diagnostics over the next five years. People will be able to get blood tests to get diagnosed early and hopefully well be a part of that.

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Q&A: discussing cancer blood testing tech with Volition - Verdict Medical Devices - Medical Device Network