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Shift in Regulation

The US Department of Health and Human Services announced last week that the Food and Drug Administration would not require laboratory-developed tests to undergo premarket review, as GenomeWeb reported

The New York Times notes the move appears to be motivated by the COVID-19 pandemic. In the announcement, HHS said CLIA-certified labs could offer tests they developed without FDA premarket review or authorization. 

"This deregulatory action will better prepare us for future pandemics while maintaining regulatory safeguards for quality and accuracy," Brian Harrison, the chief of staff at HHS, tells the Times.

GenomeWeb noted, though, that the practical effect on COVID-19 testing may be limited, as FDA already allowed CLIA-certified labs to offer tests without an EUA if they notified the agency and filed for an EUA within 15 days. However, it adds there may be a broader impact on other tests.

"I think it's quite alarming," Jeff Allen, the president and chief executive of Friends of Cancer Research, tells the Times, noting that there are more and more tests to gauge if patients' tumors will respond to particular drugs. "It's really important for the performance of those tests to be assured."

GenomeWeb notes that the announcement says FDA can still regulate LDTs through notice-and-comment rulemaking, though that is a more time-consuming process.