After a federal court vacated FDA’s final rule for laboratory-developed tests (LDTs) in 2025, did the LDT pathway fully reopen? Not exactly.

In Season 3, Episode 15 of Expert Insights, host Emily Friedland, VP of Clinical Research at DCN Dx, speaks with Jesse Young, Ph.D., Medical Director of Clinical Device Trials and Research at TriCore Reference Laboratories, and Dan Simpson, RAC, Director of Regulatory Affairs at DCN Dx.

They explain what the court decision did and did not settle, where FDA oversight ends and CMS/CLIA laboratory oversight begins, and why developers should still evaluate the regulatory and operational risks of an LDT strategy.

The conversation covers:
• Single-lab LDTs versus distributed IVDs
• FDA enforcement discretion and future regulatory risk
• RUO materials, clinical claims, and supplier responsibilities
• Certificates of analysis and supply-chain controls
• Laboratory validation, rare analytes, and funding constraints
• Designing assays for reproducibility in another operator’s hands
• Deciding whether an LDT is sustainable or should serve as a bridge to FDA clearance

Read the full transcript and episode summary:
https://dcndx.com/insights/court-vacated-fdas-ldt-rule-ivd-developers/

Discuss your LDT or IVD regulatory strategy with DCN Dx:
https://dcndx.com/contact/

Learn about DCN Dx’s Wellness Regulatory Assessment:
https://dcndx.com/wellness/

Contact TriCore Reference Laboratories:
https://www.tricore.org/contact/