Still Unhappy with FDA’s Plan to Regulate LDTs, Professional Lab Groups Go Direct to the Senate


Roger Klein, ‎Medical Director of Molecular Oncology at the Cleveland Clinic

Chapters:

Listen 0:00 What was your message to the Senate? (6:35)

Listen 6:36 Beefing up CLIA to include clinical validation (4:51)

Listen 11:27 What is your definition of LDTs? (8:27)

Listen 19:54 What is the timeline of your new proposal? (4:25)

It's no secret that America's molecular testing laboratories by and large are worried that the FDA's plan to regulate laboratory developed tests, or LDTs, will severely harm patients. Now they have a new proposal which they are taking directly to Capitol Hill.

Roger Klein is the Medical Director of Molecular Oncology at the Cleveland Clinic. He’s also serving as the spokesperson for the Association for Molecular Pathology (AMP) on the controversial topic of regulating LDTs.

Several weeks ago Roger was in Washington arguing before the Senate’s HELP Committee presenting them a newly drafted proposal that he, AMP and other professional groups feel to be a better solution to regulating LDTs. Currently the FDA is on a path to issue their final guidance for LDTs in a way that treats these lab tests as medical devices.

Klein and the professional lab groups are highly concerned that the FDA’s proposed regulation will be too restrictive and will curtail an industry just as it is blooming. Their proposal: to beef up the existing CLIA regulation so that it includes determining a test’s clinical validity. So far, CLIA has been concerned only with the analytical validity of a test.

But wait a minute, haven't we heard these arguments before? Roger explains in today’s interview that his proposal before the Senate is much more complete than what they had in January.



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