Personalization And Digital Are Pushing IVDs Onto The Health Care High Ground
Executive Summary
Investment in advanced in vitro diagnostics is increasing as the technologies themselves are becoming less esoteric and more easily "understood" by patients and providers alike. Are these technologies finally breaking through the glass ceiling to visibly assume their rightful place in health care delivery?
In vitro diagnostics champions like the UK's Sir John Bell are no longer the exception. He is not the first to talk up the vital contribution of diagnostic medicine to modern heath care. He won't be the last, but his public figure status and importance to life sciences in the UK give his words resonance. (Also see "World In Motion – The Shape Of The New Health Care Technology Ecosystem In 2022" - In Vivo, 11 Jun, 2018.) Others have doubtless said it better, but perhaps not more succinctly than his recent soundbite on the ABHI's news portal that simply said that therapy cannot work to its best without diagnostic medicine. That, and digital medicine, are the future of heath care.
Jesús Rueda Rodríguez, director for international affairs at MedTech Europe, elucidates on the theme. Speaking to In Vivo, Rodríguez said that diagnostic information is becoming more relevant to patients in a more direct way. Formerly the IVDs regulatory affairs director at EDMA (European Diagnostic Manufacturers Association), Rodríguez said two things had made a major difference in the way diagnostics were perceived and used.
Jesús Rueda Rodríguez
One is the generation of increasing volumes of personalized information that are helping patients get the right treatments at the right time. For that, the right diagnosis of the patient's condition is vital. There has been a lot of investment in genetics and in collecting information over time from patients. "We now have more results, and, because of better analysis, we are getting more out of those results," he says. Ten years ago, genetic testing was a mystery to much of the public, but now, gene tests are more routine, better accepted and more frequently requested. The information derived from them is making a big difference in the diagnosis and treatment of patients.
Communication Of Results Has Revolutionized Perceptions
And the second is a consequence of the realization that "diagnostics" is not just a lab concept, but is available to everyone as a general tool: the sector has become much better at communicating diagnostic test results. "The way that results are now being delivered means that people are really understanding the value of diagnostics." Take for example BRCA1 and breast cancer – the information seems pragmatic, less esoteric, not necessarily needing specialist knowledge, says Rodríguez. In short, everything is much clearer.
Three trends have converged to produce this perceptibly upbeat message. And although Rodríguez confesses to being a hard-wired optimist, it's a compelling enough scenario that he describes.
First of all, industry recognized the problem and began to use more data and do more studies to validate the results, thereby building more confidence in these results. Next, the physicians themselves are understanding and using the results much more often, to the extent that testing has become more routine medical practice, not just a one-off request.
And thirdly, there is no ignoring the cultural phenomenon of diagnostic testing on the patient side. High-profile news items about celebrities undergoing tests has surely played a part here, helping people to relate to tests better. The result is that diagnostics is suddenly no longer the province of doctors alone; it is a world where easy-to-obtain test results can be provided via apps that explain matters in a detailed, yet simple way. "The fact that people are more involved is driving lot of the change," he notes.
Faster results are another element. Assays are moving out of the lab and to the bedside or to the physician's office. Much faster turnaround means patients do not have to wait days to get their results.In the past, their interest may have waned as the momentum dropped, but that is less so in 2018.
Is Investment Increasing As A Result?
The IVDs space of the medtech industry has always been rich territory for R&D and innovation, Rodríguez claims, partly because of its close links to biotech. There has always been strong investment in the sector, and that is accelerating, given the increasing opportunities and the broader acceptance of the technologies. It comes from both the private and public sectors. But because of the investment culture in Europe, it is not always as easy in Europe as it is in the US, which has more appetite for risk-taking.
Those more resource-intensive diagnostic procedures can attract significantly more funding than previously. However, the traditional route to market, whereby a start-up would develop an idea from a lab or university into a straightforward, low-cost test, still exists. Rodríguez predicts that the commodity test segment side will continue to be stable.
As to point-of-care, it has yet to find its right position within health care systems. "There's no doubt that POC has huge growth potential, but maybe we are not quite there yet in delivering the solutions that people are comfortable with." The UK's BIVDA industry association recently voiced the same sentiments. (Also see "IVDs Are Hitting An Adoption 'Glass Ceiling' While A £7Bn UK Opportunity Goes Begging " - Medtech Insight, 17 Jun, 2018.)
Rodríguez is sure that IVD start-ups will continue to be picked up and developed by larger companies, but that there will also be new and interesting models of how to deliver health care, where there is much innovation ongoing that will benefit the IVDs sector. "The past system of silos and separate cost centers is starting to change, and that will definitely benefit diagnostics in the long run," says Rodríguez, observing that Germany, France, the UK, Spain and the Netherlands were leading the way on this in Europe.
Digital will drive part of the change in the IVDs sector. There is much more investment in this area, but stakeholders are still working on getting the right mix and defining how to use the technologies and make use of the information derived. "Apps require people that use them to interact with them, and we are still working on that 'experiment' on a huge scale," says Rodríguez. "It's the holy grail of health care and no one has the answer just yet."Elsewhere, some companies are already seeing themselves as service providers rather than as merely providers of tests. The major groups are all eyeing the opportunities here, and are positioning themselves differently. "Nobody expects health care to be the same in 10 years' time."
Overall, the climate for acceptance of diagnostics has improved markedly. "We're starting to find better pathways to really show clinicians the value of IVDs, and patients want to be aware of the options, and that will increase the use of IVDs." The eternal conundrum for IVDs is that these relatively low-cost tests do not share fully in the benefits they bring further along the care pathway. Pilots are said to be ongoing to demonstrate the value of diagnostics to the whole health care system.
IVDR: Short Term Pain For Long Term Quality Gain
The EU 28 is a market of some €10-11 billion for IVDs, representing 10% of wider EU medtech market. It is growing, albeit not dramatically at present, but there are fears that this growth could be trimmed, and the quality and volume of innovation ahead reduced, as a result of the forthcoming EU In Vitro Diagnostics Regulation (IVDR). "We're going to see a shift in innovation, and the IVDR will certainly have an effect," says Rodríguez. One change is that more upfront data will be required on some tests, meaning they will be better validated and better studied.
This will be a cost to manufacturers, but on the flip side, it would be help uptake over the longer term, given that the products are now better backed up by claims. Some IVD technologies will be made obsolete by IVDR, perhaps the older tests that are inexpensive but perhaps do not perform quite as well as some others. Obsolescence will not be a huge issue, maybe resulting in the loss of a few percent of the current range, Rodríguez believes. And while the IVDR will increase time to market, the products will be better quality and show better performance.
"While there will not be a significant shortfall in product availability, I am concerned about rare disease therapies – those products with low market volumes that require a very high threshold of evidence," says Rodríguez. There are ways around the problem. Rodríguez noted that tests use basically similar platforms, and so a lot of information could be useful across several tests, meaning not all tests would need to be done from scratch. In addition, there is the prospect of public or European Commissioning funding to support such products.
NB Number Not Indictive Of Coverage
Notified bodies (NBs) serving the EU IVDs market could halve in number. Current indications are that just 11 notified bodies have signaled that they will continue auditing the EU IVD sector, come May 26, 2022. This has given rise to fears about capacity and market coverage, but in Rodríguez's view, there is a need to look more deeply. "The number of NBs is a terrible metric by which to measure the IVDR. Much better is to look at the number of actual auditors."
These 11 probably cover 80% to 90% of the market, and many of the remaining NBs would be niche, he explained. The big question is, will they be ready? There is a lot of work to do, as 80% to 90% of IVDs will now need full NB oversight, as the old system of self-certification or listing in annex 1 or 2 of the IVDD is phased out. There are consequently major fears over the readiness of the system.
However, IVDs have two more years than devices to prepare, and Rodríguez observes that IVD companies, right now, were not particularly stressed. He foresees the usual last-minute scramble, but essentially considers it manageable, to the extent that the extra two years (to May 2024) of "soft" transition available for manufacturers to keep their IVDD registrations in place is unlikely to be heavily used. This would only apply to the 10% or so IVDs that were required to undergo NB auditing under the IVDD. As such, it won't be a major game changer in the IVDs field. "The IVDs industry is not over-worried so far, and the message is essentially positive," says Rodríguez. But Europe does have its hurdles. The problem for manufacturers is the sheer number of different systems, and that value is looked at differently across Europe. "You have to show it over and over again, but this is an area where we want to develop a model for easier assessment, and the European Commission is reportedly trying to develop a solution to that."
Brexit Not A Top Concern For IVDs Industry
Brexit will cause short-term disruption for the next two to three years to the wider European IVDs sector in areas such as shipping products, for instance. But it will be managed, by and large, according Rodríguez, who instead sees the top three challenges for European IVDs manufacturers as:
- Access to markets: ensuring new technology is adopted
- Innovation: finding the "right" innovation
- Visibility of IVDs: getting health systems and clinicians to engage with IVDs
In spite of these challenges, and the IVDR, the EU IVDs sector is in a good phase right now, and it does not necessarily take an "optimist by nature" like MTE's Rodríguez to see that this is a valid assessment.