Clinical Laboratory Industry on Role for FDA in Regulating Laboratory Developed Tests

July 16, 2010
For Immediate Release

Contacts: Alan Mertz, 202-637-9466;
David Mongillo, 202-637-9466;

Clinical Laboratory Industry on Role for FDA in Regulating Laboratory Developed Tests
“21st Century tests require 21st Century Solutions”

Washington, DC — The Food and Drug Administration can promote progress toward personalized medicine by approaching the oversight of laboratory developed tests (LDTs) in a focused, flexible, and balanced way according to the American Clinical Laboratory Association (ACLA). ACLA, which represents the nation’s leading clinical laboratories, says that the factors supporting this approach include the growing role that such tests play in clinical decision making, especially in the area of new advanced diagnostics that derive from the mapping of the human genome and help fufill the promise of personalized medicine.

“It is clear that in a world of new science and genetic breakthroughs that the current regulatory systems are out-of-date and steps need to be adapted to bring them into the 21st Century,” said ACLA President Alan Mertz. “Lab-developed tests are improving patient care and quality on the front lines of medicine—from enabling dramatic improvements in survival rates for childhood leukemia to transforming HIV from a killer into a chronic disease. FDA moves in this area must recognize that clinical laboratories are not traditional medical device manufacturing facilities and if strict medical device regulations are applied to the labs, important work in the development of cutting edge tests could be impeded.”

For that reason, ACLA has recommended that FDA engage in a process with stakeholders to first identify any gaps in regulation and then meet to reach consensus on approaches that both protect public health and preserve the ability of clinical labs to innovate. ACLA said that the issues that must be addressed include:

  • Identify and better understand the differences between laboratory services and In Vitro Diagnostics (IVDs) used by clinical labs to perform tests
  • Reach consensus on gaps in oversight
  • Discussion toward consensus of the criteria for risk-based categorization of tests,
  • Determine the appropriate evidence requirements linked to each risk based category of tests
  • Recognition of the need to grandfather the vast majority of well-accepted and well-understood tests already in clinical use to avoid disruption in patient care
  • Discussion of the gaps between the FDA quality system regulations and the Clinical Laboratory Improvement Amendments (CLIA) quality requirements

“ACLA members are the experts on how clinical laboratories operate – including how tests are developed, validated and how quality is ensured,” Mertz said. “We recognize the need to communicate that information more effectively to FDA. We also recognize that we must understand better FDA’s regulation of medical devices. We hope to continue a constructive two-way communication with FDA toward this shared understanding. ACLA pledges our active support and engagement to reach a timely and positive outcome.”

ACLA will present its views at a special FDA conference on July 19 – 20 on the appropriate regulatory oversight for laboratory developed tests. ACLA’s statement to FDA on the oversight of laboratory developed tests is available at

Advanced tests developed in clinical reference laboratories have played a critical role in better and more effective care for a wide range of conditions. Genetic tests, for example, have largely enabled the development of personalized medicine. Such tests allow earlier identification of disease; predicting the risk of disease before symptoms occur, thus allowing earlier treatment; and helping physicians select the specific medication that will best treat the disease. Examples include HIV resistance testing; BCR/ABL testing for chronic myelogenous leukemia; Fragile X testing for developmental delays; KRAS mutation testing to reduce or eliminate side-effects of colon cancer treatment; testing to identify how quickly a person’s body metabolizes certain drugs, thus permitting more effective dosing and reduced side-effects; and testing for rare genetic diseases like Gaucher, Tay-Sachs, Canavan among so many others. In addition, advanced diagnostic tests have helped protect the public health of the nation by allowing for the identification of SARs, Avian Flu, West Nile Virus and more recently H1N1. Although many more examples exist, these underscore why lab developed tests—and their ability to respond rapidly to new and often menacing health challenges—should continue to be introduced in a flexible and balanced way.

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