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Update on the Regulation of LDTs: FDA, VALID Act, CLIA Modernization, and More

Sponsored by the ACMG Advocacy and Government Affairs Committee

May 21, 2024 | 2:00 – 3:00 pm ET

Educational Credits are not offered.

Description:

Join members of ACMG’s Advocacy and Government Affairs Committee and Policy Team to hear updates on potential changes to the regulation of laboratory-developed tests (LDTs) in the US. Speakers will provide updates on the current status of the FDA’s proposed rule on regulation of LDTs and its implementation. They will also provide updates on congressional involvement, including legislative efforts such as the VALID Act and CLIA Modernization.

Target Audience

All healthcare professionals.

Agenda

Michelle McClure, PhD – Intro & FDA update (15 minutes)

Marco Leung, PhD, FACMG – VALID Act (15 Minutes)

Sarah South, PhD, FACMG – CLIA Modernization (15 minutes)

Q&A (15 minutes)

Learning Objectives

At the conclusion of this session, participants should be able to:

1. Summarize the current regulatory and legislative landscape of proposed policies that would change how LDTs are regulated.
2. Assess the impact of the FDA rule on LDT regulation on clinical testing laboratories.
3. Explore the remaining opportunities to block or overturn the FDA proposed rule on LDTs.

Michelle McClure, PhD

 ACMG Director of Public Policy

Marco Leung, PhD, FACMG

Advocacy & Government Affair Committee Chair

Sarah South, PhD, FACMG

ACMG Board of Directors