The Association for Diagnostics & Laboratory Medicine (ADLM) released the results of a survey the organization conducted to determine how the Food and Drug Administration’s (FDA’s) proposed laboratory-developed tests rule would impact patient care.
The survey found that, if enacted, the FDA’s rule would force children’s hospitals to outsource tests to commercial clinical labs, which could lead to life-altering delays in diagnosis and treatment for sick children.
Further reading: Labs Express Concern about Testing Access if FDA Regulates LDTs
The Significance of Laboratory-Developed Tests
Laboratory-developed tests are tests that clinical labs create and perform in-house to meet the needs of their local patient populations. These tests are currently regulated by the Centers for Medicare & Medicaid Services (CMS) via the Clinical Laboratory Improvement Amendments (CLIA).
CLIA already subjects these tests to rigorous oversight, and ADLM believes that any reforms to laboratory-developed test regulation should be made by updating CLIA legislation. However, FDA has been trying for years to place these tests under dual FDA-CMS oversight, despite the fact this additional regulation would be duplicative and burdensome for clinical labs. In the FDA’s latest attempt to push this through, the agency has pursued unilateral regulatory reforms through rulemaking that go beyond its statutory authority.
Further reading: Is There a Balancing Point for LDT Regulations?
How FDA Regulation of LDT’s Would Impact Patient Care
To determine just how FDA regulation would impact patient care, ADLM conducted the first of several surveys to identify the challenges that clinical laboratories would face if the FDA’s proposed rule went into effect. Hospitals and academic centers across the U.S. that perform clinical testing were invited to complete the survey. In the first week, 140 U.S. clinical labs responded to the survey, 87% of which said they perform laboratory-developed tests.
One of the survey’s most worrying findings was that the FDA’s proposed rule would have a significant adverse impact on children’s hospitals. Among the children’s hospitals that are developing a contingency plan to deal with FDA oversight, 71% stated that they would outsource many tests if laboratory-developed tests become FDA regulated. This could significantly delay diagnosis and treatment and is particularly concerning for tests used to diagnose and monitor genetic disorders in infants, where every minute of delay can contribute to brain damage and the risk of severe disability.
Further Impact on Children’s Hospitals
Additionally, more than half of children’s hospitals with contingency plans would switch to FDA-approved tests in certain cases. This could also lead to subpar care because some FDA-approved tests, such as immunoassay drug screens, are less accurate or effective at identifying parent drugs and their metabolites than their laboratory-developed test counterparts.
“If laboratory developed tests become FDA-regulated, children’s hospitals could be forced to make exceedingly difficult tradeoffs at the expense of patient care,” says ADLM President Octavia Peck Palmer, PhD. “While ADLM shares FDA’s goal of ensuring that laboratory developed tests are safe and effective, we need to balance that with preserving the accessibility of these tests — especially for the most vulnerable patient populations. ADLM’s survey findings underscore the fact that placing these tests under additional FDA oversight would undermine care for children across the U.S.”
Graphic of select survey results courtesy of the Association for Diagnostics & Laboratory Medicine (ADLM)
