
The EU Market Access Playbook for Diagnostics Companies - Svetlana Nikic
In this episode of Diagnosing Dx, I’m joined by Svetlana Nikic, Founder of Precision Oncology Consulting.Svetlana shares her journey from Roche and Illumina into building her own consultancy focused on helping diagnostics companies navigate the realities of market access in Europe. We explore the gap between innovation and implementation, why strong science alone does not guarantee patient access, and what US diagnostics companies often underestimate when they look at Europe as a commercial opportunity.We also discuss what it really takes to make oncology diagnostics work across European markets, from KOL engagement and clinical utility studies to health economics, reimbursement strategy, and the complexity of regional healthcare systems. This is a practical conversation about precision oncology, policy, and why implementation may now matter more than innovation.Key takeaways:🔹 Why innovation without implementation does not create real patient impact🔹 What diagnostics companies need to understand before entering Europe🔹 Why clinical utility alone is often not enough for reimbursement in European markets🔹 How KOL engagement, local evidence, and health economics shape adoption🔹 Why diagnostics now needs more implementation focus and less innovation for innovation’s sakeGuest:Svetlana NikicLinkedIn: https://www.linkedin.com/in/svetlananikic/Host:David FilbyLinkedIn: https://www.linkedin.com/in/davidfilby/Chapters:01:50 Svetlana Nikic’s background in diagnostics and oncology07:37 What Precision Oncology Consulting helps companies do in Europe10:25 When diagnostics companies should start planning for Europe15:23 How reimbursement works across European markets19:22 Why KOL engagement is so important for market access20:57 Choosing the right European market and identifying low-hanging fruit25:28 Why the reimbursement bar is often higher in Europe43:30 Diagnostics in 2026: implementation, policy, and what needs to change next🔔 Subscribe to Diagnosing Dx for weekly conversations with leaders shaping the future of diagnostics and omics.#PrecisionOncology #Diagnostics #MarketAccess #Reimbursement #Europe #Oncology #BiomarkerTesting #healthcarepolicy #ClinicalUtility #HealthEconomics #CancerDiagnostics #LifeSciences #HealthCare #PrecisionMedicine #Innovation










