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LDT Rule Will Have Massive Impact, Analysts Say; Fundamental Questions Remain

 
• By Brian Bossetta

Stakeholders are still processing the US FDA’s proposed rule that would place lab-developed tests under its regulatory purview. While only time will tell what it all means, it is already clear that the agency’s action, if finalized, will significantly affect the healthcare industry and above all patients.

The Rules Have Changed
• Source: Shutterstock

It’s no surprise the Food and Drug Administration decided to flex its regulatory muscle over laboratory-developed tests (LDTs) – Commissioner Robert Califf has made it clear for a year now that the agency’s rulemaking authority was on the table; and when Congress failed to act on diagnostic reform last year, it almost became a certainty the FDA would do so unilaterally.

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