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Laboratory Developed Tests (LDTs)
Patient Perspective on Value of LDTs Video
ACMG/AMP/ISDA Congressional Briefing on Laboratory Developed Tests
FDA Laboratory Developed Tests (LDTs) Responses
On Tuesday September 20, 2016, ACMG joined forces with the Association for Molecular Pathology and the Infectious Diseases Society of America to co-sponsor a Congressional Briefing on the basics of laboratory developed tests (LDTs) and the vital role they play in patient care
, What do Cancer Moonshot, PMI, ZIKA and the CARB National Action Plan All Have in Common?
Over 50 people were in attendance. Briefing materials are below:
Briefing Agenda
One-Page Summary: The Basics of Laboratory Developed Tests
Briefing Speaker Slides
Title
Date Submitted
Document
ACMG LDT Position
October 2015
PDF
One-Page Memo
October 2015
PDF
Background Information about ACMG
October 2015
PDF
LDT Laboratory Coalition Letter to Congress
October 2015
PDF
Docket No: FDA-2011-D-0360: Framework for Regulatory Oversight of Laboratory Developed Tests; Draft Guidance for Industry, Food and Drug Administration Staff and Clinical Laboratories; Availability
February 2015
PDF
Docket No. FDA-2011-D-0357: FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)
February 2015
PDF
AMA Coalition Letter
November 2014
PDF
Follow-up to ACMG/AMP Webinar, “Impending Actions on Laboratory Developed Tests (LDTs)”
On March 1, 2016 a webinar was held, that explains the imperative to regulate oversight of LDTs, ACMG’s position on possible regulatory actions and how impending Federal policies have the potential to threaten patient and physician access to genetic testing.
Webinar Slides
Send a Letter to your Federal Representatives
using ACMG’s template, designed for rapid action with an area to add specific comments and relevant data.
Members of the House Energy and Commerce (E&C) Committee
Members of the Senate Health Education, Labor and Pensions (HELP) Committee
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