In the fast-paced field of life sciences, digital pathology is poised to be a game-changer.

In this episode, we sit down with Grace Lee and Douglas Clark of Agilent Technologies to explore the opportunities and challenges associated with companion diagnostics (CDx).

Clark kicks off, shedding light on the current levels of digital pathology adoption in both clinical trials and practice. Thereafter, Lee outlines several opportunities and the associated regulatory hurdles, looking at areas such as the utilization of whole slide images for companion diagnostic interpretation.

Pointing to the amplified scrutiny on Laboratory Developed Tests (LDTs) and the emerging CDx guidelines in the EU and China, she emphasizes the importance of aligning with agencies: “Oftentimes we are trying to manage changes in the CDx world by providing regulators with evidence that assay performance has not changed.”

Clark echoes these sentiments, first highlighting the challenges posed by image variability and the resultant disparities in CDx interpretation and scoring, and then offering an optimistic outlook on the transformative potential of AI in the realm of multiplexing assays.

For a deep dive into the opportunities presented by digital pathology and CDx development, tune into the full episode.