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:

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Docket No: FDA-2011-D-0360: Framework for Regulatory Oversight of Laboratory Developed Tests; Draft Guidance for Industry, Food and Drug Administration Staff and Clinical Laboratories; Availability February 2015 PDF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.