IVDs and LDTs and Companion Diagnostics, Oh My!

In this 154th episode of the Combinate Podcast, host Subhi Saadeh is joined by Devon Campbell to venture into the complex world of in vitro diagnostics (IVDs), lab-developed tests (LDTs), and companion diagnostics. Much like Dorothy’s journey through the land of Oz, navigating IVD development requires courage, brains, and a heart for innovation. Devon shares insights drawn from his vast experience in both big pharma and startups, shedding light on the challenges and surprises along the way.

The conversation touches on the high-stakes nature of risk management in diagnostics. As Devon explains, “In the IVD space, we are delivering very important information about the patient. If that information is wrong, the implications can be massive.” False positives or negatives aren’t just technical issues — they can lead to critical mistakes in patient care. Devon also dives into the rigorous processes of design, verification, and validation, revealing why startups often find the journey longer and more resource-intensive than expected.

‘People are often surprised by how much time and money is required for clinical testing toward the end of IVD development. It’s never just a simple check — the stakes are too high for that.’

Just as Dorothy had to navigate unexpected twists and turns on her way to the Emerald City, bringing an IVD to market demands careful planning, especially when precision medicine and patient outcomes are at stake. Whether you’re a diagnostics professional or curious about the role of companion diagnostics in precision medicine, this episode offers valuable insights and practical advice for avoiding pitfalls.

Ready to follow the yellow brick road to successful IVD development? Listen to the full episode for actionable strategies and lessons learned from decades of experience. Listen now and prepare for your IVD journey!