What's Next for POC Diagnostics?

If you don’t work within the diagnostics space, then you’d be forgiven for thinking that the industry’s role in combating COVID-19 is coming to an end. After all, we have multiple vaccines.

However, if you do work in diagnostics, you’ll understand that this couldn’t be further from the truth. Now that numerous mass vaccination programs are underway, diagnostic testing has become even more crucial. Without it, how will know that our vaccines are working?

As well as measuring efficacy, testing can help us learn more about the virus and support wider reaches of the population. For example, if a vaccine is only 90% effective, then testing can identify the 10% of people that it’s not working for. Once we distinguish who these people are, we can start to rectify the issue.

So, diagnostic testing is still vital. But now we have numerous COVID-19 tests, what’s next for the industry?

Jonathan O’Halloran, CEO at QuantuMDx

This question led me to a conversation with Jonathan O’Halloran, who is CEO at QuantuMDx – a diagnostics company that’s sought to support the NHS and UK throughout the pandemic by scaling up its Q-POC rapid point-of-care testing device.

Having taken over as CEO on 24^th January 2020, Jonathan has been at the helm of QuantuMDx from the early days of the pandemic. Over the last 12 months, he’s seen the market develop and change in fascinating fashion.

You can listen to our discussion as a CM Conversations podcast here.

More Understanding, Funding & Innovation

The public and the media now have a greater understanding of diagnostics.

People know what PCR means and are starting to understand sensitivity, specificity, NPB and PPV. Even the press is becoming more critical when it’s assessing new technologies. I think that can only benefit proper diagnostic companies like ourselves.

This improved knowledge of industry is something that diagnostics companies have not experienced before. It will be interesting to see how they manage this new relationship with the public, which will demand more transparency and clarity with results.

While the media spotlight has shifted to the vaccination programs this year, the attention diagnostics received in 2020 has also had an impact on funding. This should motivate new innovations throughout the market.

It’s unlikely that we’ll see too many new devices come to market in 2021 because of the lengthy development pathways they require. However, Jonathan claimed new start-ups can be expected to emerge with novel chemistries to make incremental improvements on current devices. We could also see more well-known technologies, like AI, discover applications in diagnostics too.

Already, we’ve seen the use of nanopores enter the space with Oxford Nanopore and its LamPORE COVID-19 test.

A Shifting Focus

At CM Life Science, we’ve also spoken about how COVID-19 has accelerated the adoption of at-home testing kits. For a detailed article on how diagnostics is moving closer to the patient and at-home testing, please read: “Diagnostics is Changing to Meet Your Demands”.

This trend is having a major impact on the industry, with consumers demanding quicker, easier and more convenient testing. To support this, multiplexing will be crucial.

With at-home testing, there’s no doctor present to provide an empirical diagnosis nor direct the patient to other specific diagnostic tests. That means the tests need to look at more than one indication. Multiplexing is required to look at multiple markers and provide actionable results for patients.

Jonathan was keen to stress that multiplexing is the future of POC diagnostics, not just at-home testing.

People forget that we’re in the midst of another pandemic at the moment, which is arguably worse: the anti-microbial resistance pandemic.

To be able to address this, any molecular technology or other diagnostic has to look at multiple markers - not only a pathogen ID, but then an indication of the drug resistance status. That requires looking at multiple different drug resistant mutations all within a single test.

QuantuMDx's COVID-19 assay has been developed for multiplexing, whether that’s looking at a panel of mutations or a panel of different pathogens. The test is expected to have a clinical sensitivity and clinical specificity percentages in the high nineties, making it one of the most sensitive tests on the market.

The assay has been designed with the most up-to-date sequence information available to ensure 100% coverage of all known SARS-CoV-2 sequences. This involves in silico analysis against the GISAID database every two weeks, or whenever new variants of concern are identified.

Even without the selective pressure of a vaccine, we’ve seen multiple new variants appear. With vaccination programs ongoing globally, more new variants are likely. This type of comprehensive testing remains crucial to tell us how our vaccines are working against these new variants.

Going Commercial

QuantuMDx is not the only diagnostics company to have experienced rapid growth, as a result of its response to COVID-19. The likes of LightDeck Diagnostic, BrainBox and Quadrant BioScience have also had similar stories, with many transitioning from research and development (R&D) companies to more commercial ones in 2021.

Jonathan has signalled QuantuMDx’s intent to become a significant international diagnostic company by onboarding a Chief Commercial Officer, Diran Guiliguian who has joined from Siemens Healthineers. The company believe that this will act as a springboard to develop their business into Europe and the US.

Despite the company’s success, it's clear Jonathan is solely focused on defeating the pandemic.

The only way we’re going to beat this pandemic is by giving all of the nations around the world the tools to defeat it.

He also plans to expand the company into Africa, where QuantuMDx began its journey. However, this will come later and require significant recruitment to succeed.

The Future

While many diagnostic companies will be looking to expand, it’s important to consider life beyond the pandemic too. This is something that’s front-of-mind for a lot of diagnostics leaders like Jonathan.

My worry is that post-pandemic there's going to be a lot of devices left doing nothing, as well as big manufacturing facilities and capacities that may not be needed anymore. So, I've been trying to urge my team and anybody at the government who’d listen to have a plan for the end of this.

So, to answer the questions I posed at the start of this article. There’s a lot next for POC diagnostics. It will play a major role in measuring the success of our vaccination programs, innovate with novel chemistries, continue to shift to at-home testing and multiplexing, as well as help us understand new variants of COVID-19.

If you’ve enjoyed this article or have any feedback, please get in touch by emailing Nathan.Sharpe@lifesci-cm.com.

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