Navigation Links
The Association for Molecular Pathology releases position statement on LDTs

Bethesda, MD, December 18, 2013: The Association for Molecular Pathology (AMP) released a special article in the January 2014 issue of the Journal of Molecular Diagnostics titled "Revisiting Oversight and Regulation of Molecular-Based Laboratory-Developed Tests"(LDTs). The article was authored by the Laboratory Developed Tests Working Group of the AMP Professional Relations Committee. "The article serves as a re-affirmation of AMP's continued assertion that the CLIA program, in combination with laboratory accreditation programs and professional certification, provides a rigorous and flexible framework for ensuring high quality laboratory testing in the United States," said Elaine Lyon, PhD, AMP President.

The article includes an overview of different group's perspectives on LDTs. Approaches of the FDA and AdvaMed are compared to those of ACLA, CAP, and others including an upcoming HHS report on the issue. Taking all of these viewpoints into account, the AMP report hones in on the specific services integrated within existing LDTs. Unlike traditional medical devices, LDTs rely on the critical role of the laboratory professionals who help design, consult on follow-up testing, and interpret the test results.

This important distinction resulted in AMP's proposal of the term Laboratory Developed Procedures (LDPs) to be used in place of Laboratory Developed Tests, and this is a key element of the paper. The definition of AMP's new term, Laboratory Developed Procedure is: A professional service that encompasses and integrates the design, development, validation, verification, and quality systems used in laboratory testing and interpretive reporting in the context of clinical care. "The services inherent in LDPs are provided by highly trained laboratory professionals including; pathologists, molecular geneticists, and other clinical laboratory scientists," said Andrea Ferreira-Gonzalez, Chair, AMP LDT Working Group. "The new term accurately describes the integral expertise of the clinical laboratory professional."

The working group also re-affirmed AMP's prior position that some very high-risk tests do require pre-introduction review by a third party reviewer and outlined the types of LDPs to which this would apply. To download a PDF of the article, visit: To view other AMP position statements and letters, visit:


Contact: Catherine Davidge
Association for Molecular Pathology

Related medicine news :

1. Avitus Group Helps Chase Hawks Memorial Association Recruit for New Position: Executive Director
2. DocbookMD Launches Integrated Radiology Service with Austin Radiological Association
3. The Florida State Hospital Association Becomes Supporting Organization of the Healthier Hospitals Initiative
4. 2014 American Heart Association Go Red for Women Chair Natalie Baro
5. Metro Maryland Ostomy Association, Inc. Is Pleased to Announce the Launch of Its New Flagship Project, "IT GUTS BETTER" in Concert with Our 40th Anniversary Celebration
6. Association of Nurses in AIDS Care Announces Chief Nursing Officer
7. National Association of Professional Women Announces Keoma L. Hamer, Founder and President of The KeLaHa Projects Foundation, as VIP Woman of the Year
8. National Association of Professional Women Announces Paula J. Meyers, M.S.N., C.S.R.N., R.N., System Director at OhioHealth Stroke Network, as VIP Woman of the Year
9. The NAPW Announces Lisa E. Harris, Ph.D., Director/Program Coordinator, Project Hope at Mental Health Association of Nassau County, as VIP Woman of the Year
10. National Association of Professional Women Announces Tammie Langdon, Manager at CVS Caremark, as VIP Woman of the Year
11. Antiaging Medicine and Research Conference "INDOMEDICON 2014" to be Held in Mumbai in Collaboration with World Anti-aging Network & Medical Wellness Association USA
Post Your Comments:
(Date:6/25/2016)... Austin, TX (PRWEB) , ... June 25, 2016 , ... ... Fellow of the American College of Mohs Surgery and to Dr. Russell Peckham for ... popular and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic ...
(Date:6/25/2016)... California (PRWEB) , ... June 25, 2016 , ... "With ... fit their specific project," said Christina Austin - CEO of Pixel Film Studios. ... customizable and all within Final Cut Pro X . Simply select a ProHand ...
(Date:6/25/2016)... CA (PRWEB) , ... June 25, 2016 , ... As ... with Magna Cum Laude and his M.D from the David Geffen School of Medicine ... and returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of ... recognition of their exemplary accomplishments in worksite health promotion. , The Wellness at Work ... Symposium at the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses ...
(Date:6/24/2016)... ... 2016 , ... A recent article published June 14 on E ... goes on to state that individuals are now more comfortable seeking to undergo not ... as calf and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... CLEMENTE, Calif. , June 24, 2016  American Respiratory Labs ... company, is now able to perform sophisticated lung assessments in patients, ... Technologies , Inc. Patients are no longer limited ... ndd,s EasyOne PRO ® , ARL patients like Jeanne R. of ... done in the comfort of her own home. ...
(Date:6/24/2016)... , June 24, 2016   Pulmatrix, Inc ... company developing innovative inhaled drugs, announced today that it ... Russell Investments reconstituted its comprehensive set of U.S. ... "This is an important milestone for Pulmatrix," said ... increase shareholder awareness of our progress in developing drugs ...
(Date:6/23/2016)... HOUSTON , June 23, 2016  MedSource ... platform as its e-clinical software solution of choice.  ... the best possible value to their clients by ... nowEDC.  The preferred relationship establishes nowEDC as the ... pricing for MedSource,s full-service clients.  "nowEDC has long ...
Breaking Medicine Technology: