Opportunities & Challenges of Digital Pathology Adoption in CDx Development

In the dynamic world of life sciences, digital pathology stands out as a beacon of innovation, promising transformative changes in how pathologists engage, evaluate, and collaborate.

In this episode, we sit down with two distinguished experts, Grace Lee and Douglas Clark from Agilent Technologies, to explore the booming landscape of companion diagnostics (CDx).

Clark opens the conversation by shedding light on the current landscape of digital pathology adoption in both clinical trials and practice, emphasizing the escalating trend towards integration.

Lee then navigates us through the intricate regulatory hurdles surrounding the utilization of whole slide images and AI algorithms for CDx interpretation. She reminds us that getting the chemistry right is a crucial first step before implementing a digital scoring algorithm. She also speaks on evolving regulatory frameworks, highlighting the increasing scrutiny on Laboratory Developed Tests (LDTs) and the new CDx guidelines in the EU and China.

Lee also outlines the importance of collaborating across industry and with regulatory agencies, working towards changing perceptions in relation to the use of digital solutions in CDx development.

“Oftentimes as regulatory professionals, we are not trying to make claims that assays are improving over time. Instead, we are trying to manage changes in the CDx world by providing regulators with evidence that assay performance has not changed and is still selecting the same clinical population as originally intended and tied to drug efficacy.” she states.

Clark echoes these sentiments, emphasizing the challenges posed by image variability and the resultant disparities in CDx interpretation and scoring. However, he counters with an optimistic outlook on the transformative potential of AI, particularly in the realm of multiplexing assays.

For a deep dive into the vast opportunities presented by digital pathology and the steps required to realize its full potential, don't miss out on the complete podcast episode. Tune in now!


The editorial staff had no role in this post's creation.