Panakeia joins digital health companies shaping the future of AIaMD regulation  

At Panakeia, we are tackling one of the biggest challenges in healthcare: slow, resource-intensive molecular testing workflows that delay access to precision medicine. Patients often wait weeks for essential biomarker results due to overstretched pathology services and complex laboratory workflows.  

Our technology helps healthcare professionals get answers faster, reduces pressure on overstretched molecular and pathology labs, and supports earlier, more informed clinical decisions – making precision medicine more accessible at scale.  

Since completing the DigitalHealth.London Accelerator, we have made considerable progress across product development, clinical deployment and evidence generation. In addition to our breast cancer molecular profiling software, PANProfiler Breast, we have launched and deployed our colorectal cancer software, PANProfiler Colorectal (MSI/MMR), in multiple NHS hospitals. Both solutions are now approved for use in the UK.  

We have also expanded partnerships with leading NHS Trusts, including Leeds Teaching Hospitals NHS Trust and NHS Lothian, and have demonstrated that our technology can streamline diagnostic workflows, reduce turnaround times and alleviate pressure on overstretched molecular testing services. These advancements have strengthened our clinical evidence base and enhanced our regulatory readiness.  

Off the back of these successful deployments, our commercial traction continues to accelerate both across the UK and internationally, alongside growing interest in several additional cancer indications.  

We applied to the AI Airlock because it’s a unique opportunity to work directly with the MHRA in a “safe-to-test” environment. It’s a collaborative opportunity to transparently explore challenges together, understand evidence needs, and ensure AI technologies meet the highest standards.  

For Panakeia, this aligns directly with our patient-first mission. Participating in the AI Airlock helps ensure our precision cancer tools are not only innovative but clinically robust, evidence-driven, and ready for safe, scalable adoption across the NHS and beyond.  

A key challenge is that AI regulation is still evolving, and innovators need clearer, more predictable pathways to bring safe, effective products to patients quickly. This includes developing fit-for-purpose approaches for generating evidence, demonstrating robust performance, and managing ongoing model and product improvements in a way that reflects how AI technologies operate in practice. 

We view this not as a barrier, but as an opportunity to work closely with regulators to co-develop approaches that accelerate innovation while maintaining the highest standards for patient safety.  

Through the AI Airlock, we want to help shape how AI-powered diagnostic tests are assessed and approved. We’re using our PAN Profiler Colorectal (MSI/MMR) test as an example to explore what ‘fit-for-purpose evidence’ looks like for AI IVDs 

Through the AI Airlock, we want to help shape how AI-powered diagnostic tests are assessed and approved. We’re using our PAN Profiler Colorectal (MSI/MMR) test as an example to explore what ‘fit-for-purpose evidence’ looks like for AI IVDs.  

Traditional lab tests can generate different results depending on the method or the laboratory in which tests are conducted, which makes it hard to define a single standard for accuracy or ‘ground truth.’ By working closely with the MHRA, we aim to understand how AI can provide more consistent, reliable measures of performance. 

As a multi-environment candidate, we will test PANProfiler Colorectal (MSI/MMR) in both simulation workshops and a virtual data environment. This means we can explore regulatory scenarios with experts in a simulated setting, such as through round-table discussions, and test how our AI performs using real clinical data in a controlled, non-clinical environment.  

By working across more than one environment together with expert stakeholders, we can gain a deeper understanding of how our product (and other AI IVDs) behaves in practice, what fit-for-purpose evidence is needed, and how best to meet regulatory expectations. This will ultimately help us to ensure our AI diagnostics are safe, reliable and ready for real-world use.  

Working with partners across healthcare, research and regulation means we can develop AI tools that are safe, practical, and ultimately benefit patients.  

Each group brings something essential: clinicians show us what works in hospital settings, academics help strengthen science, charities ensure patient needs stay at the centre, and regulators make sure everything meets the highest safety standards.  

For new technologies like AI diagnostics, no single organisation has all the answers. Collaboration helps reduce uncertainty, create clearer standards, and speed up safe adoption. Most importantly, it builds public trust by ensuring AI is developed responsibly, openly and with patient benefit front and centre.  

Working alongside six other innovators gives us a chance to learn from teams tackling similar challenges in different ways. Each company brings its own experience – whether that’s how they build their AI, how they work with data, or how they approach regulation. By sharing what’s worked and what hasn’t happened, we can spot common challenges and explore solutions together.  

It’s also incredibly helpful to see how others think about safety, evidence and real-world use. This kind of open learning strengthens the whole sector and helps ensure that AI technologies reach patients sooner, safely, and with greater confidence. This collaborative learning environment strengthens the entire UK AI ecosystem.