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A Call for LDT Regulation

The New York Times editorial board thinks it is high time that the Food and Drug Administration take a stand on regulating lab-developed tests and publicly release the draft guidelines it has been working on to regulate LDTs.

The Times says that regulations of LDTs "are long overdue," because the number of these tests and labs that offer them have been expanding, and because there is the potential for real harm if they are not regulated.

The paper's editorial board cites a speech FDA commissioner Margaret Hamburg gave at the American Society of Clinical Oncology's annual meeting in Chicago last month, in which she gave the example of the OvaSure ovarian cancer screening test as a reason for regulating LDTs.

That test was not validated adequately, Hamburg told the ASCO conference. OvaSure fell into a crack in the regulatory framework, and healthcare providers later raised alarms about its validity. Hamburg has admitted that FDA does not know how many women had received erroneous results from the test, and the agency forced the test to be pulled from the market.

In her ASCO speech, Hamburg suggested that FDA is prepping to advance some new regulations.
Her words spurred action from the LDT industry, as the American Clinical Laboratory Association submitted a petition to FDA saying that the agency does not have the authority to regulated LTDs, and that a better solution would be to amend CLIA and not "impose an additional layer of regulation based on a different statute designed for products rather than laboratory testing."

The Times points to the bifurcated regulatory landscape that these tests, in which tests from device makers are regulated by FDA and tests that labs develop and fall under the Centers for Medicare & Medicaid Services' CLIA purview, as a problem.

"The F.D.A. has always had the authority to regulate laboratory-developed tests but chose not to do so when tests were used locally…. But the landscape has changed with the advent of more sophisticated tests and the rapid expansion of commercial laboratory companies."

The Times says that an "alarming number of diagnostic medical tests have never been tested for safety and accuracy," and urges FDA to take action.

Likely, the Times suggests, the draft guidelines currently may be stalled in the Office of Management and Budget, "a frequent graveyard for regulatory initiatives.