ACMG/AACC/AMP/APC Joint Webinar on Laboratory Developed Tests (LDTs)

On Tuesday, October 26, 2021, ACMG, together with the American Association for Clinical Chemistry (AACC), the Association for Molecular Pathology (AMP), and the Association of Pathology Chairs (APC), hosted a webinar on The Regulatory Landscape of Laboratory Developed Testing Procedures: How we got here, why it’s important, where we’re going, and how you can get involved. Recordings and slides of the four presentations given during the webinar are available below.

Module 1: Background on LDTs

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Module 2: The Importance of LDTs to Clinical Care

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Module 3: Past and Current LDT Policy Proposals

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Module 4: Advocating for LDTs

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Relevant ACMG Statements & Letters

 

Current LDT Legislation

Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021
Summary: If passed, the VALID Act would create a single regulatory pathway under the Food and Drug Administration (FDA) for all in vitro clinical tests (IVCTs), which includes manufactured laboratory tests and LDTs. All LDTs would be under the jurisdiction of FDA, and they would also continue to be regulated by the Centers of Medicare and Medicaid Services (CMS) through the Clinical Laboratory Improvement Amendments (CLIA).

House Bill: HR 4128

Senate Bill: S 2209


Verified Innovative Testing in American Laboratories (VITAL) Act of 2021
Summary: If passed, the VITAL Act would clarify that LDTs, referred to in the legislation as laboratory developed testing procedures, are regulated solely by the Centers of Medicare and Medicaid Services (CMS) through the Clinical Laboratory Improvement Amendments (CLIA). The bill would also require the Secretary to hold a stakeholder meeting to inform modernization of CLIA.

House Bill: TBD

Senate Bill: S 1666