FDA to start regulating lab-developed tests

Published on NewsOK Modified: July 31, 2014 at 2:52 pm •  Published: July 31, 2014
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WASHINGTON (AP) — The Food and Drug Administration announced Thursday it will begin regulating laboratory-developed tests, a growing class of medical diagnostics that have never before been subject to federal oversight.

The agency says its proposal is designed to make sure that the tests used to diagnose cancer, heart disease and thousands of other conditions are safe, accurate and reliable.

"Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether," said FDA Commissioner Dr. Margaret Hamburg, on a call with reporters. "These devices need to be accurate and reliable."

In recent years scientists have documented laboratory-based tests that provided incorrect results for diagnosing conditions like autism, Lyme disease and antibiotic resistance.

Hamburg said the agency will introduce a proposal to regulate these tests within the next 60 days.

Regulation of laboratory-developed tests has been a subject of debate since at least the 1990s. Several federal advisory committees, including the Institute of Medicine, have recommended that the FDA exercise more authority over such testing. That's also been the position of diagnostic test manufacturers, who have long been subject to rigorous FDA reviews before they can launch new products. The industry has complained to Congress and the FDA that their products must compete with cheaper laboratory-developed tests that have not undergone federal testing.

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