Bioanalytics
Steven Piccoli, PhD (he/him/his)
Head, Clinical Biomarkers
Sun Pharma Advanced Research
Princeton, New Jersey
Patrice Hugo, PhD (he/him/his)
Chief Scientific Officer
IQVIA Laboratories, Quebec, Canada
Lauren Stevenson, PhD (she/her/hers)
Chief Scientific Officer
Immunologix Laboratories
Tampa, Florida
Mark Ma, PhD (he/him/his)
VP, Head of Translational Sciences and Early Development
Biotech
New Haven, Connecticut
The FDA’s proposed rule regarding Laboratory-Developed Tests (LDTs) has significant near-term implications for both the drug development paradigm and clinical laboratories. If finalized, the FDA will regulate virtually all LDTs as medical devices. This change will impose new regulatory requirements on those clinical laboratories offering diagnostic or exploratory biomarker tests as LDTs, extending far beyond the current scope of routine bioanalysis. These laboratories will face new obligations related to reporting, labeling, and quality systems and the proposed rules could cause a dramatic shift in how LDTs are regulated, and ultimately accessed and used. Laboratories will need to make difficult decisions about whether or not to develop novel tests, or which existing LDTs they can continue to offer, potentially affecting patient access to essential diagnostic tests, while drug developers will encounter the same issues in their testing to support clinical trials for regulatory approvals of therapeutics.
>The Rule and implementation date
>Regulatory implications - short and long term
>New biomarker testing paradigm for clinical trials
>Changes in trial endpoints
>Changes in timelines and costs
>Path forward for testing