ADLM survey suggests FDA LDT oversight will disrupt toxicology testing

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New regulatory enforcement policies for laboratory developed tests (LDTS) will force many clinical laboratories, especially those in hospitals, to discontinue critical tests such as those that identify prescription and illegal drug use, according to a new survey by the Association for Diagnostics and Laboratory Medicine (ADLM).

ADLM's survey went out to clinical laboratories across the U.S. According to ADLM, a majority of 128 respondents said that they do not have the staff or resources to fulfill new U.S. New Food and Drug Administration (FDA) regulatory requirements, even though some tests are exempted. The survey noted that the types of tests at risk for discontinuation include toxicology tests for methamphetamine, fentanyl, opioids (e.g., oxycodone), barbiturates, and cocaine.

Additionally, more than half of the labs that won't be able to comply new FDA requirements anticipate discontinuing some of their exempt tests, ADLM said in a statement.

"We appreciate that the FDA has tried to include provisions in its final rule with the aim of preserving patient access to laboratory developed tests," said ADLM president Dr. Octavia Peck Palmer in the statement. "But the fact still remains that clinical labs are not medical device manufacturers, nor are laboratory developed tests the mass-manufactured devices that the FDA currently regulates. This means that the FDA's regulatory framework is simply not appropriate for laboratory developed tests, and the results of ADLM's survey demonstrate that placing these tests under FDA oversight will only hinder patient care and critical public health initiatives."

ADLM noted that it has sent a letter about the survey results to the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) and the House Committee on Energy and Commerce.

View the letter and full survey results here.

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