LTR 148: Chris Daly on Companion Diagnostics, AI, and FDA’s Evolving Approach
Let's Talk Risk! Podcast
- Published
- March 20, 2026
- Duration
- 29:02
- Summary source
- description
- Last updated
- Apr 29, 2026
Discusses ai.
Summary
Summary“Test, test, test - and don’t accept the outcome unless you’re fairly confident in the level of uncertainty that remains.”Companion diagnostics (CDx) are inherently high-consequence because they can directly shape treatment decisions. That reality drives a higher bar for clarity: intended use boundaries, evidence expectations, and tight specificity…
Show notes
Summary“Test, test, test - and don’t accept the outcome unless you’re fairly confident in the level of uncertainty that remains.”Companion diagnostics (CDx) are inherently high-consequence because they can directly shape treatment decisions. That reality drives a higher bar for clarity: intended use boundaries, evidence expectations, and tight specificity in what the test is claiming and for whom.In this Let’s Talk Risk! conversation, host Naveen Agarwal sits down with Chris Daly to discuss how
Themes
- ai