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

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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 fulfill 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"It is clear that in a world of new science and genetic breakthroughs that the current regulatory systems are out-of-date and steps need to be adapted to bring them into the 21st Century," said ACLA President Alan Mertz.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.