Navigation Links
The Association for Molecular Pathology releases position statement on LDTs
Date:12/18/2013

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: http://dx.doi.org/10.1016/j.jmoldx.2013.10.003. To view other AMP position statements and letters, visit: http://www.amp.org/publications_resources/position_statements_letters/2013AMPPositionStatements.cfm.


'/>"/>

Contact: Catherine Davidge
cdavidge@amp.org
301-634-7400
Association for Molecular Pathology
Source:Eurekalert

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:
*Name:
*Comment:
*Email:
(Date:3/24/2017)... ... March 24, 2017 , ... According to a new ... invalid because it does not obey the rules Congress has directed the CBO to ... which the GOP reform would restore. Yet, it estimates a reduction in employer-based coverage ...
(Date:3/24/2017)... ... March 24, 2017 , ... Mlynarek ... services to families and business owners across eastern Michigan, is connecting with the ... struggling with financial difficulties. , The Oxford/Orion FISH Food Pantry works to ensure ...
(Date:3/24/2017)... ... March 24, 2017 , ... ... wanted to create a communications platform that positions them as the go-to thought ... ONS reinvented their online publication as an always-on, always-fresh news, views and advocacy ...
(Date:3/24/2017)... (PRWEB) , ... March 24, 2017 , ... The law ... White Plains, N.Y., is pleased to announce Westchester resident Lauren C. Enea has joined ... clerk for the firm, will concentrate her practice in elder law, Medicaid planning and ...
(Date:3/24/2017)... ... March 24, 2017 , ... Empower ... upgrading their training and leads programs. , In February, 2017, Empower Brokerage introduced ... agents, Performance Partners is designed to teach how to maximize their sales efforts, ...
Breaking Medicine News(10 mins):
(Date:3/23/2017)... 23, 2017 Mosaic Life Care, based in St. Joseph, Missouri ... across its network of 58 clinics, located in 22 cities, and its flagship St. ... ways to improve the delivery of health care to its patients, including the insurance, ... ... Mosaic Life Care St. Joseph Medical Center ...
(Date:3/23/2017)... Executive Summary ... primary research (inputs from industry experts, companies, stakeholders) ... the analysis of global heart valve devices market ... Replacement Procedure By Technique (Mechanical, Bioprosthetic, Transcatheter Aortic ... Balloon Valvuloplasty, Transcatheter Mitral Valve Repair (TMVR)), By ...
(Date:3/23/2017)... , March 23, 2017 ... Pharmaceutical and Healthcare disease pipeline guide Primary Hyperoxaluria ... of the Primary Hyperoxaluria (Genito Urinary System And ... a rare condition characterized by recurrent kidney and ... a substance called oxalate. Symptoms include blood in ...
Breaking Medicine Technology: