The Association for Molecular Pathology releases position statement on LDTs

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.

Explore further: AMP releases statement on diagnostics in drug labels

Related Stories

AMP releases statement on diagnostics in drug labels

May 16, 2011

Today, the Association for Molecular Pathology (AMP) released its new position statement on the appropriate manner to reference diagnostic tests in drug labels. The association also met with officials from the United States ...

FDA draft guidance document may limit patient access to tests

August 30, 2011

The Association for Molecular Pathology (AMP) submitted comments to the US Food and Drug Administration on the draft guidance document titled, "Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use ...

AMP opposes exclusive licensing of NIH proteomics patent

November 22, 2011

The Association for Molecular Pathology (AMP) opposed the National Institutes of Health (NIH) proposal to exclusively license the subject matter of a cancer-related proteonomics patent application filed by the Agency. AMP's ...

Recommended for you

Sustaining biomedical research: Med school deans speak out

May 27, 2015

Cuts in federal support and unreliable funding streams are creating a hostile work environment for scientists, jeopardizing the future of research efforts and ultimately clinical medicine, according to leaders of the nation's ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.