COVID-19 was endemic at Molecular Med Tri-Con 2021, not only in the way it was presented – virtually of course – but also in the agenda. In amongst the COVID diagnostics track were signs that maybe we were moving, if not to a completely post-COVID world, but to a place where we can live with it and manage future mutations. The mood was set by Karen Kaul, chair of pathology and laboratory medicine at NorthShore University HealthSystem, who kicked the track off with a ‘lessons learned’ session that focused on a framework for future success.
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With that forward-thinking theme in mind, one of the key aspects emerging from Tri-Con that struck me was how we work as an industry to bring healthcare solutions to patients more quickly. And by that, I mean solutions covering areas such as disease diagnosis, management and vaccination. When it comes to pace of development in the diagnostics space, speed is of the essence right now. In fact the buzz at Tri-Con took me back to the early days of the pandemic, when the team here at Cambridge Consultants pulled out all the stops to develop a sophisticated emergency ventilator in just six weeks.
The FDA’s director of in vitro diagnostics and radiological health Timothy Stenzel maintained the upbeat mood with his update on molecular testing for COVID. He revealed that his organisation had authorised 238 diagnostic tests since the pandemic struck, 40 of which were home collection kits. Steven Schachter a professor of neurology from Harvard Medical School and chief academic officer at RADx expanded on this during his discussion on the power of collective action. He described how the US Congress took just five days to sign into law legislation to support the development, production scale-up and deployment of accurate, rapid tests across the US.
Over a six month period this initiative evaluated over 700 applications and moved 22 projects into large-scale manufacturing. One of these, from Australian company Ellume, became the first over-the-the counter fully at-home test to be authorised by the FDA. You can read more about our work to develop its breakthrough sensing technology here. As well as molecular diagnostic tests, the FDA also authorised antigen tests – important because they can be produced in significantly larger numbers.
Authorised tests in 12 months
All this increased testing capability resulted from an unprecedented rate of development. Authorised tests and vaccines were brought to market in 12 months instead of the usual 12 years or more. This of course poses a big question. With such a rate, does quality drop or does streamlined regulatory rigour encourage much-needed breakthroughs in design and scientific techniques?
Let me go back to World War II for an analogy. The imperative to prevail in a time of incredible turmoil and threat drove extraordinary innovation. The first jets, for example, flew at the end of the conflict and although they didn't contribute significantly to its outcome, they were perfectly placed to drive development in the airline industry post-war. The story of the digital computer, of course, follows an even more direct link to the period. The efforts of code breakers led to the first electronic computer and then to an entirely new industry and way of structuring society.
The considerable experience we have at Cambridge Consultants when it comes to streamlining development relies on rigorous systems engineering. Success comes from identifying requirements and suitable architectures early and planning testing from the start. We believe, and have proved, that medical developments can be safely delivered to quicker timescales. Perhaps we’re currently going though a step change in bringing more rapid medical innovation to the patient. The team here is certainly ready to play our part.
Looking beyond the pandemic, it was good to see the continuing push for developing and delivering specific medicines targeted at tumours with particular mutations. Kristin Beaumont from Icahn School of Medicine at Mount Sinai gave a great talk during which she described her passion for single-cell analysis. Kristen outlined a variety of techniques to access a wide range of omic information from transcriptomic analysis of messenger RNA, DNA mutation profiling and protein expression. It was particularly interesting to hear her description of multi-omic analysis from a single cell and how this can push forward diagnosis in rare disease.
Enabling precision medicine
This drive for precision medicine is opening up a range of new medicines and treatments. Hakan Sakul, VP and head, diagnostics at Pfizer, spoke brilliantly about enabling precision medicine, outlining his vision to deliver the right drug to each patient. I was particularly impressed with how Pfizer is integrating the pharmaceutical development part of its business with relevant diagnostic development. This parallel development approach is essential to ensure that highly targeted pharmaceuticals are suitable to work in a practical manner alongside accurate and deployable diagnostics.
Of course, to deliver precision medicine and facilitate early diagnosis of rare disease requires the manipulation of either single or at least rare cells. Currently, these cells are often lysed soon after capture or become unviable through lack of a suitable environment. The work we are doing here directly addresses this – as outlined by my colleague Josh Gibson in his talk on the CellPreserve platform, which extends the viable life of captured rare cells from hours to weeks. Longitudinal morphological analysis of the cell alongside an assessment of expressed proteins opens a new chapter on rare cell analysis which sits alongside the work discussed by Kristin Beaumont.
My overall takeaway from Tri-Con 2021? It was great to see the phenomenal efforts the molecular diagnostic world has put into managing COVID, but equally reassuring to see that the work necessary to help cancer patients and patients with rare diseases have a better outcome is still progressing at pace. For me, the fact that my fantastic colleagues at Cambridge Consultants are helping to push forward on both fronts is very satisfying.