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



Module 2: The Importance of LDTs to Clinical Care



Module 3: Past and Current LDT Policy Proposals



Module 4: Advocating for LDTs



Relevant ACMG Statements & Letters


Current LDT Legislation

Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022
Summary: The FDASLA includes the new user fee agreements for medical devices, drugs, generic drugs, and biosimilars, which must be passed by Sept. 30th, 2022 to avoid disruption of FDA’s review activities. Currently, the FDASLA also includes the text from the VALID Act of 2022 (subtitle C, sections 821-830) as well as many other provisions on topics unrelated to FDA user fees, such as regulation of cosmetics, supplements, and infant formula.

Senate Bill: 4348

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