Diagnostics and screening is in the middle of significant change, partly as a result of the advances in care whereby near patient testing and other disruptive modalities are now being introduced and also as a direct result of the change in regulatory environments, specifically in Europe. These changes are likely to totally alter the landscape when it comes to the deployment of diagnostics as the changes in the pipeline are far reaching and very significant.

EUDAMED is the new IT system developed by the European Commission as an integral part of MDR (medical device) and IVDR (In vitro diagnostic device) regulation implementation. It aims to enhance transparency about medical devices and in vitro diagnostics by improving access for health professionals as well as the public. It will also have the effect of enhancing coordination amongst EU member states. Even though it’s not fully in place yet, companies are getting ready, planning for medical and diagnostic devices, including those using AI.

In diagnostics, there’s a lot of new activity.

For example precision therapeutics, a key development within precision medicine, involves creating treatments tailored to individuals based on their genetic makeup or specific biomarkers. This approach allows for more targeted and effective treatments. However, it also introduces regulatory challenges, as both the treatments and the diagnostic tests used to determine a patient’s eligibility for them require approval. As precision medicine evolves, treatments for rare diseases may become more specialized, leading to a limited number of prescriptions for these treatments and potentially higher costs. This shift towards precision therapeutics represents a significant change in how treatments are prescribed and administered, focusing on individual patient characteristics for better outcomes.

Preventive diagnostics is set to change healthcare even more drastically. We’re developing new methods to predict the likelihood of diseases not only through stable, unchanging genetic information but also through other indicators like changes in genes due to lifestyle (epigenetic switches), gut bacteria (microbiome), and more.

These new types of tests are much more affordable than traditional genetic testing and can help monitor how a patient’s health progresses or worsens over time. They can be done on large groups of people, providing an up-to-date view of health trends across entire populations. The technology behind these tests is impressive, allowing for a wide array of diseases to be checked with a simple finger prick method from home, eliminating the need for clinical lab visits.

This approach to diagnostics is significant because it includes a variety of tests that can detect many common diseases and can be done easily at home, making it unnecessary to go to a lab. This not only makes it easier for individuals to keep track of their health but also offers a broader understanding of health trends within a population.

These advancements are set to transform healthcare by alerting us to potential illnesses much earlier. This means we can either take steps to treat them immediately or prevent them before they start.

Moreover, these methods will help address health inequalities. By understanding the health challenges facing underserved communities in real time, healthcare providers can focus on those who need care the most, fundamentally changing how we approach diagnostics.

You might wonder if this is just another big promise, like the digital transformation that seemed slow to materialise until the COVID pandemic forced rapid change. I don’t believe so. Some technologies, like ChatGPT, have shown how fast innovation can be adopted. In diagnostics, the need for economic and political change will likely speed up the adoption of these technologies faster than we anticipate.

How do you envision these diagnostic innovations shaping the future of personalized healthcare, and what implications could they have for the way we prevent and treat diseases in your community?

– Dr. Charles Alessi,
Chief Clinical Officer of éditohealth and Steering Committee member of Radical Health Festival