ACLA Expresses Strong Support for Bill Modernizing Regulation of Lab-Developed Tests

For Immediate Release, October 14, 2011

Contact: Alan Mertz, 202-637-9466

ACLA Expresses Strong Support for Bill Modernizing Regulation of Lab-Developed Tests

Washington DC – The American Clinical Laboratory Association (ACLA) today announced its “full and strong” support for legislation introduced by Rep. Michael Burgess (R-TX) that would modernize the current regulatory pathway for all laboratory developed tests.

The legislation, H.R. 3207, the Modernizing Laboratory Test Standards for Patients Act, would establish a notification and review process at the Centers for Medicare and Medicaid Services—which now regulates the safety of clinical labs—that would allow the agency to evaluate the clinical validity of the tests.

“This bill reflects the need for government regulation to keep pace with the advancements in science that will move our health care delivery system to one focused on what is best for the patient, public health, and the economy,” wrote ACLA in a letter to Rep. Burgess endorsing the bill. “In particular, we note the legislation’s effectiveness in reaching these goals by strengthening the current regulatory structure and eliminating duplicative regulation; enhancing public transparency for patients, providers and regulatory agencies; and strengthening reporting for adverse events—all without additional government expenditures.”

ACLA went on to say that the approach taken in the legislation would accelerate progress toward a personalized medicine revolution. “A hallmark of that revolution is the contribution that clinical laboratory developed tests continue to make in enabling better informed diagnosis and better targeted care,” said the ACLA letter. “The clinical laboratory industry is constantly innovating with new tests that detect and diagnose disease as well as inform the treating physician whether a drug or biologic is an effective means of treating a particular patient.” The letter added that the legislation will help ensure the accuracy and reliability of these tests while maintaining the integrity of the current regulatory framework.

In commenting on the legislation, ACLA President Alan Mertz commended Rep. Burgess for modernizing the regulatory structure created by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). “This legislation offers a modern, innovative, and flexible approach that builds on the success of CLIA,” said Mertz. “It avoids regulatory overlap and redundancy, while assuring consumers that laboratory developed tests are reliable and accurate. This is a balance that will encourage continued innovation and protect consumers.”

ACLA is an association representing clinical laboratories throughout the country, including local, regional, and national laboratories.

For a copy of the ACLA letter, go to

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