Date of Award
7-16-2025
Document Type
Capstone Project
Degree Name
Master of Science in Medical Laboratory Sciences (MSMLS)
Department
Department of Medical Laboratory Sciences
First Advisor
Karen Reiner
Abstract
Abstract
In the article “The Future of Laboratory Medicine Understanding the New Pressures," author Mauro Panteghini expresses that the clinical laboratory has always undergone significant changes due to technological advances and external economic pressures. “Laboratories are indeed an easy target for economic restrictions and limitations due to their technological characteristics.” (Panteghini, 2004, pg. 205) Though these words were written over 20 years ago, no more valid words have been spoken in light of the newest pressure all laboratories face with the new LDT regulation set by the FDA.
This regulation places drastic economic pressure on laboratories to pay the FDA for laboratory-developed tests that vendors have not defined or submitted initially. It is essentially coercing laboratories to decide what tests are deemed “unmet needs” and what tests can be discontinued to avoid having to pay fees to develop package inserts for tests established by these labs and considered helpful by the FDA for continued use for patient testing. It feels like a revenue-generating scheme by the FDA that forces labs to either quit the innovative approach for testing solutions they have provided for years or pay the mandatory fines to continue testing. This will be an economic strain on many hospital labs, proving detrimental to all stakeholders.
Recommended Citation
Henry, Charma, "LDT FDA Ruling: a Conundrum for Laboratories Across the USA" (2025). MSMLS Capstone Projects. 2.
https://digitalcommons.andrews.edu/msmls/2