11. company entrusted by its clientele to deliver forward-thinking solutions that are compliant with the most stringent regulatory standards. miDiagnostics’ core programme focuses on rapid sterility testing for CAR-T and other advanced therapy batch releases. Using its proprietary silicon-based PCR technology, the company enables biopharmaceutical companies to dramatically reduce release times for life-saving therapies. In a highly specialised area – where every hour matters – miDiagnostics’ platform can help save countless lives by accelerating access to personalised treatments. At the heart of everything miDiagnostics does lies a deep commitment to people. Whether pushing the boundaries of diagnostic science, pivoting an entire business, or navigating complex ecosystems, the company has and always will champion an unfaltering dedication to promoting the human side of innovation. As Katleen explained: “Innovation only matters if it reaches patients, if it empowers teams, and if it transforms lives. That is the lens I apply to every decision I make as a CEO.” Of course, the journey has not been without its challenges for miDiagnostics, though Katleen’s strategic, human-centric approach has driven the company forward even in the face of adversity. One of the most defining challenges Katleen has faced during her time at miDiagnostics has been navigating the transition from COVID-19 to a post-pandemic landscape. At the height of the pandemic, miDiagnostics developed one of the fastest, most accurate RT-qPCR tests on the market – a true benchmark in point-of-care diagnostics. When the urgency of the pandemic subsided, however, so too did the demand for such solutions. As with many diagnostic companies, miDiagnostics was faced with a stark reality: choose reinvention or risk irrelevancy. Whilst the industry moved en masse toward respiratory panels and STI testing, miDiagnostics made the deliberate and bold decision to pivot towards pharmaceutical services – focusing specifically on the field of sterility testing in cell and gene therapy, where their PCR platform can have a transformative impact. This pivot not only required technological reorientation, but also strong leadership through a period of great uncertainty. “Investors were understandably cautious,” Katleen recalled, “internal teams were anxious about the unknown and external stakeholders were divided in their expectations. Yet we remained committed to our vision, adapting quickly, communicating transparently, and making data-driven decisions to realign the organisation around a new, more sustainable direction. That strategic shift is now proving to be highly successful.” A second significant obstacle that miDiagnostics has navigated has been scaling its platform from lab-scale prototypes to industrial-grade, validated systems that can operate reliably at scale. Innovation within the field of diagnostics can be inconsistent, often stalling between proof-of-concept and real-world implementation. miDiagnostics, however, has made significant strives in this sphere by embracing multidisciplinary collaboration, conducting rigorous validation, and engaging world-class partners to accelerate industrialisation efforts, such as Thermo Fisher. Since joining miDiagnostics, Katleen has directly demonstrated that when an individual is willing to question their assumptions, adapt strategically, and lead with clarity, transformation not only becomes possible, but impactful. This attitude towards emerging obstacles has shaped Katleen’s approach, opened her eyes to the importance of authenticity and transparency in leadership – enabling her to better serve her team at miDiagnostics. “I believe we need to talk more openly about resilience in leadership,” she told us. “Not just celebrating success, but acknowledging the ambiguity, the pivots, and the tough calls that come with building something meaningful. True leadership is not about having all the answers; it is about being willing to listen, adapt, and bring others with you on the journey.” And for miDiagnostics, the journey is far from over; as we progress through 2025, the company is focused on expanding its pharmaceutical services offering – with a particular emphasis on ultra-fast, highperformance PCR sterility testing for CAR-T and other Advanced Therapy Medicinal Products. These are areas where demand for speed, reliability, and compliance is only increasing over time and, under Katleen’s expert guidance, miDiagnostics is well-positioned to support that growth. As for Katleen, she has never been one to follow a formal career plan. Instead, the CEO has been fortunate to encounter opportunities throughout her journey, making conscious decisions based on where she currently is in life, the impact she believes she can make, and the time and energy she can commit to each project. These ventures are never financially motivated, instead driven by purpose – specifically the potential for science and technology to create meaningful change for patients and society. Equally important to Katleen is giving back. She believes it her responsibility to mentor the next generation of leaders – especially CEOs navigating the complex landscape of life sciences. Having walked the path from deep academic science to venture-backed entrepreneurship and executive leadership, Katleen recognises that sharing what she has learned and learning from them in return is one of the most meaningful ways she can contribute to shaping a future built on purpose and innovation. Moving forward, Katleen informed us that she will continue to observe the broader industry as it advances, keeping a close eye on specific areas of interest. She shared: “Looking ahead, I remain energised by the promise of cell and gene therapies to redefine the boundaries of medicine. I’m also increasingly intrigued by the frontiers of neuroscience, artificial intelligence, and their broader implications for human health and society. These are not just intellectual results; they reflect a deep curiosity about the future of life, cognition, and connection.” Contact: Dr. Katleen Verleysen Company: miDiagnostics Web Address: www.midiagnostics.com
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