US FDA to roll back lab-developed test oversight rule following court decision

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(Reuters) -The U.S. Food and Drug Administration will rescind a rule that tightened regulations for clinical laboratories and gave the agency more oversight of diagnostic tests developed by them, a document on the Federal Register showed on Thursday.

The rule will become official after it gets published on September 19.

This follows the United States District Court for the Eastern District of Texas’ decision to vacate the rule in March.

Last year, the Association for Molecular Pathology, a nationwide group of doctors and scientists involved in diagnostic testing, asked a court to block the rule.

AMP called it “a historically unprecedented power grab that will jeopardize the health of hundreds of millions of Americans” and impose tens of billions of dollars in new costs on laboratories.

The American Clinical Laboratory Association, a medical lab industry group, had also filed a similar case.

“The action will help to assure patient access to innovative and targeted diagnostic tests while reducing regulatory burden and costs for both hospitals and the federal government,” said Roslyne Schulman, American Hospital Association’s director of public health policy.

The rule on lab-developed tests was announced in April last year. LDTs, as opposed to commercially produced tests that are marketed with FDA approval, are developed for use within a single lab. They are frequently used to test for cancer, genetic mutations and blood markers of diseases.

The FDA had said at the time more oversight was needed because LDTs have become much more widely used by healthcare providers. The agency had issued a report in 2015 highlighting certain types of LDTs that could harm patients, including tests with a high rate of false results for cancer and fetal genetic abnormalities.

(Reporting by Puyaan Singh in Bengaluru; Editing by Alan Barona)