ACMG/AMP/ISDA Congressional Briefing on Laboratory Developed Tests 

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

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 



FDA Laboratory Developed Tests (LDTs) Responses


ACMG, along with the American Medical Association, have written to Dr. Margaret Hamburg, FDA Commissioner, in response to FDA's proposed guidance “Framework for Regulatory Oversight of Laboratory Developed Tests”.  Please see below for the two ACMG responses as well as other related communication.

 

 

October 2015

Title

Date Submitted Document


ACMG LDT Position

One-Page Memo (PDF)
Background Information about ACMG (PDF)
October 2015 PDF

AMA Coalition Letter 

November 2014 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Docket No: FDA-2011-D-0360: Framework for Regulatory Oversight of Laboratory Developed Tests; Draft Guidance for Industry, Food and Drug Administration Staff and Clinical Laboratories; Availability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
LDT Laboratory Coalition Letter to Congress PDF

Patient Perspective on Value of LDTs Video