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IVD Makers And Clinical Labs Wary Of LDT Rule Effects

Ongoing Lawsuits Add To Complications

 
• By Elizabeth Orr

Clinical labs and diagnostics firms alike are still grappling with the likely impact of the FDA’s final rule on LDTs, speakers said in a recent webinar. Key areas of concern: The potential for lab consolidation, lack of clarity on when clearance is necessary, research-use tests, and the hesitation imposed by an ongoing lawsuit and upcoming election.

Young scientist leans forward with a worried expression on his face.
(PeopleImages.com/Shutterstock)

With litigation and a fast-approaching election complicating the picture, clinical labs and IVD manufacturers alike are still sizing up potential outcomes of the US Food and Drug Administration’s final rule on LDTs, speakers said during a 21 October webinar sponsored by 360Dx and ZeptoMetrix.

For labs, a key concern remains the potential business effects of the increased regulatory burden.

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