Fireside Chat: LDT Compliance in an Uncertain Environment

Wednesday, November 20, 2024

5:15 PM – 6:15 PM PST

Location: 211, Level 2

Corporate Workshop Speaker(s)

JL

Jordan Laser, MD

Senior Director, Clinical & Medical Affairs
Bio-Techne
LD

Leanne Deptula, MS

Director of Operational Excellence
Versiti
AK

Annette Kim, MD, PhD

Professor of Molecular and Genomic Pathology
University of Michigan
HW

Heather Williams, PhD, MS

Chief Operating Officer
Cache DNA

With so much uncertainty around the FDA’s LDT Rule, it is challenging for laboratory leaders to make firm plans for how to achieve compliance. This session will consider three different tactical approaches for stage I of the rule: a) labs actively preparing for compliance; b) labs preparing, but cautiously using resources; and c) labs that are deferring preparation. No matter where your lab is on the spectrum, please join this interactive session as we discuss aspects of each approach and the practicalities of adjusting to the new regulatory landscape.