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:6/24/2017)... ... , ... The weather is heating up and the days are getting longer, ... aware that the summer months provide more than warmer temperatures that are perfect for ... negatively affected from direct exposure to the sun. When it comes to the security ...
(Date:6/23/2017)... ... June 23, 2017 , ... "The Better ... ultimately do significant harm to people with all chronic conditions, including mental illnesses, ... leaves in place the Affordable Care Act (ACA) requirement that insurers cover pre-existing ...
(Date:6/23/2017)... , ... June 24, 2017 , ... Studies show evidence ... reduce the risk of visual loss in these patients. , But how often do ... or smoking cessation to patients at risk of or with early symptoms of AMD? ...
(Date:6/23/2017)... ... June 23, 2017 , ... Military Connection ... denied entry to the JFK Virgin Atlantic lounge. , Bensko is no stranger ... six years ago, Bensko dedicated her life to supporting our wounded veterans. A world-class ...
(Date:6/23/2017)... ... ... The Aesthetic Channel has recently highlighted Dr. Ben Talei’s unique approach to ... technique that he calls the AuraLyft Facelift. The AuraLyft does more than ... expect to look refreshed, rejuvenated, and revitalized. , Dr. Talei’s unique approach stems ...
Breaking Medicine News(10 mins):
(Date:6/3/2017)... , June 3, 2017  Eli Lilly ... announced that results from the Phase 3 MONARCH ... (CDK)4 & 6 inhibitor, in combination with fulvestrant, ... with fulvestrant alone in women with hormone-receptor-positive (HR+), ... breast cancer who have relapsed or progressed after ...
(Date:5/30/2017)... May 30, 2017 Hill-Rom Holdings, Inc. (NYSE: HRC), ... Global Healthcare Conference on Tuesday, June 13, 2017, in ... , Hill-Rom,s president and chief executive officer, is scheduled to ... audio webcast can be accessed at http://ir.hill-rom.com/events.cfm . A ... the live event through September 13, 2017. ...
(Date:5/26/2017)... SANTA BARBARA, Calif. , May 25, 2017 /PRNewswire-USNewswire/ ... the United States , Direct Relief is working ... of overdose-reversing Naloxone available at no cost to community ... and other nonprofit providers nationwide. "Pfizer ... expanding access to medicines and ensuring patient safety through ...
Breaking Medicine Technology: