miDiagnostics: Transforming the Delivery of Advanced Therapies

For patients awaiting life-saving cancer treatments, every hour matters. Based in Leuven, Belgium, miDiagnostics develops ultra-fast testing technology that helps ensure personalised medical treatments used to fight cancer are safe and ready to use as quickly as possible.

Pioneering biotechnology company miDiagnostics delivers ultra-rapid PCR-based testing solutions designed to meet the unique demands of advanced and novel immuno therapies such as CAR-T in the battle against cancer. By enabling sterility results in under two hours rather than several days, the company is helping deliver treatments faster, safely and with confidence. For patients whose time is limited, that difference can be life-changing.

Solving a Critical Bottleneck in Modern Medicine

CAR-T therapy, a revolutionary treatment that uses the patient’s own immune cells to fight cancer, is one of the most promising developments in oncology in recent years.

Unlike traditional medicines, CAR-T therapies are manufactured individually for each patient. Immune cells are collected, genetically modified to recognise cancer cells, and then returned to the patient. This highly personalised process offers remarkable clinical potential, but it also introduces new manufacturing challenges.

Before any treatment can be given to a patient, it has to be carefully checked to ensure it’s completely free of contamination.Traditional sterility testing methods can take several days, creating a delay between manufacturing and start of the treatment. For patients with aggressive cancers, that delay can carry serious consequences.

miDiagnostics addresses this challenge using advanced PCR technology; a method that rapidly detects tiny traces of microbial contamination in under two hours. This dramatic reduction in testing time allows to accelerate treatment delivery while maintaining the highest safety standards.

Speed and Quality Combined

While speed is a defining feature of miDiagnostics’ technology, quality and regulatory confidence remain at the heart of its strategy.

In pharmaceutical manufacturing, sterility testing is closely linked to regulatory approval. Each treatment requires validated testing methods that demonstrate safety and compatibility with the manufacturing process. This complexity demands rigorous quality standards and close collaboration between technology providers and pharmaceutical manufacturers.

By working closely with partners throughout the validation process, the company supports pharmaceutical companies in meeting strict regulatory expectations while reducing time-to-treatment. This dual focus, which balances speed with regulatory confidence, has become one of the company’s defining strengths.

From Scientific Foundations to Commercial Scale

miDiagnostics was founded in 2015, built on strong scientific expertise and a commitment to advancing PCR-based diagnostic technology. From the beginning, the company invested heavily in research and development, assembling a highly skilled team of scientists capable of pushing technological boundaries.

However, translating innovation into real-world impact requires more than scientific excellence. That next phase began in 2021, when Katleen Verleysen joined the company as CEO.

While the organisation already possessed strong research capabilities, her appointment brought a new dimension to the company, opening new doors into commercial growth and global scalability.

A trained chemist, Verleysen built her career on a strong scientific foundation, formalised through the PhD she obtained, which shaped her understanding of how complex technologies are developed, tested, and validated. This technical background gave her not only credibility within highly specialised scientific environments, but also the ability to translate complex innovation into practical, real-world applications.

Expanding her career beyond the laboratory, she moved into leadership roles across the life sciences and technology sectors. There, she developed extensive experience working at the intersection of innovation, strategy, and commercial development, helping organisations transform promising scientific breakthroughs into scalable products and services.

This combination of scientific expertise and commercial leadership proved critical when she joined miDiagnostics in 2021. While the organisation already possessed strong research capabilities and a highly skilled team of scientists, Verleysen recognised the need to build the infrastructure required to scale globally.

Focusing on strengthening operational structures and commercial viability, she used her extensive network contacts to assemble a multidisciplinary team that bridged science and business, developing a commercial strategy capable of bringing advanced testing technology from the laboratory into real-world clinical environments.

Partnerships That Drive Innovation

miDiagnostics has adopted a collaborative model designed to integrate seamlessly into pharmaceutical workflows. By working alongside leading industry organisations, the company ensures its solutions address real-world operational needs.

Collaborations with globally recognised institutions, including imec, have supported the development of cutting-edge technology, while clinical and validation partnerships with major life sciences organisations such as Thermo Fisher Scientific have strengthened the pathway to commercialisation.

Today miDiagnostics is working with some of the largest pharmaceutical companies in the world to evaluate and implement rapid sterility testing solutions in CAR-T manufacturing environments. These partnerships create credibility, scale, and trust, all of which are essential for companies operating in regulated healthcare markets.

Expanding the Scope of Immunotherapy

Although oncology remains the most visible application of immunotherapy today, the broader potential of rapid sterility testing extends well beyond cancer.

Immunotherapy is rapidly emerging as a transformative treatment approach across multiple disease areas, including autoimmune disorders. As researchers explore new ways to harness the immune system to treat chronic conditions, the demand for safe, rapid, and reliable manufacturing processes will continue to grow.

miDiagnostics is positioning itself to support this expanding landscape. By enabling faster sterility validation across a wide range of advanced therapies, the company’s technology could help unlock new treatment pathways for millions of patients worldwide. 

This broader vision reflects a shift in healthcare itself, from one-size-fits-all medicine to highly personalised therapies tailored to individual patients.

A Future of Smarter, Personalised Treatments

As personalised medicine continues to evolve, the pace of innovation is accelerating across the global life sciences sector. New therapies are emerging not only for cancer, but for autoimmune and other complex conditions that were once considered difficult to treat.

For companies like miDiagnostics, the opportunity lies in supporting this next wave of medical progress; helping pharmaceutical partners deliver increasingly complex therapies safely, quickly, and at scale.

For Katleen Verleysen, the significance of this work is not purely professional, but deeply personal, and she’s motivated by playing an integral role in the eradication of cancer and other autoimmune conditions. 

She reflects on her son’s future, imagining a world where treatments such as chemotherapy may one day no longer be necessary, replaced by highly targeted therapies that work with the body’s own immune system.

That vision may still be years away, but the foundations are already being laid.

miDiagnostics has quickly established itself as a leader in diagnostic innovation, earning multiple high-profile awards and recognitions. The company was named Top MedTech Startup in Europe, while Katleen Verleysen has been celebrated for her leadership, receiving European CEO of the Year 2024 and 2025, Top Innovative Chief Executive Officer in Life Sciences at BIO-Europe 2025, and the Exemplary Woman of Achievement award at the Burj CEO Awards 2025. Other honours include the Alychlo Deal of the Year 2025, being shortlisted as MedTech of the Year finalist 2025, securing FDA 510(k) clearance for rapid diagnostic tests, and selection for the UNAIDS Health Innovation Exchange program. Together, these accolades underscore miDiagnostics’ pivotal role in delivering faster, safer, and more accessible testing solutions for advanced therapies.

As the industry moves toward more precise, personalised treatments, the organisations capable of turning scientific breakthroughs into practical, accessible solutions are defining what the future of medicine looks like. And miDiagnostics is certainly a name to watch.