FDA to regulate new diagnostic tests for safety, reliability

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WASHINGTON — The Food and Drug Administration said Thursday that it plans to begin regulating certain diagnostic tests developed by laboratories, which have proliferated and grown more sophisticated in recent years, spurring increased concerns about their safety and reliability.

Just as new drugs must be proven safe and effective before reaching consumers, the devices used to diagnose complex medical conditions also must work properly to avoid subjecting patients to harmful or unnecessary treatments, FDA Commissioner Margaret Hamburg said. “We must make sure that the information is accurate, consistent and reliable,” she said.

For decades, the FDA has chosen not to actively regulate “laboratory developed tests,” or LDTs, because they tended to be simple devices used to diagnose rare or “low-risk” diseases. In recent years, however, the tests have become more widely used and more specialized, able to diagnose specific forms of cancer and other diseases with complex genetic data.

Government regulators say the evolution makes it more critical than ever to ensure that the tests are safe and trustworthy and that patients who rely on them aren’t misdiagnosed. Several incidents in recent years have underscored those concerns, including instances in which the reliability of LDTs for cervical cancer, Lyme disease and whooping cough have been called into question.

Until now, the FDA has relied on a two-tiered approach for regulating diagnostic tests. The agency has long reviewed devices made by traditional manufacturers before they hit the market to ensure their safety and accuracy. But in the past, tests developed and sold by a single laboratory generally have not been subject to “pre-market” review. As diagnostic testing has become a staple of medical decision-making, many laboratories that once produced tests only for use by local doctors and patients morphed into marketing their diagnostics to much broader populations.

Under the new proposal, the FDA said, only the most “high-risk” LDTs would have to prove their safety and efficacy before going to market. Eventually, they would have to adhere to the same rules as tests produced by traditional manufacturers, including abiding by good manufacturing practices and reporting any adverse events associated with their tests.

Any new requirements also would be phased in over several years, and lower-risk diagnostics, including those for rare diseases or for conditions for which no other test currently exists, would be exempt from the expanded oversight, FDA officials said.

The American Clinical Laboratory Association, an industry group, has repeatedly argued that LDTs already face stringent oversight under a federal law that requires monitoring of the reliability of the tests.


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