FDA Releases the Kraken

Thursday, July 31, 2014

After our big news a couple weeks ago, a number of people have asked me whether our blog would get crushed out of existence. There are a few things we'll probably need to adjust, but I'm pleased to say that Illumina is cool with me continuing to write in one form or another. I just hope my old stuff didn't have anything to do with turning Jay Flatley's hair white.

So now that I'm sitting up straight and combed my hair a bit, what's the news? Turns out today is a red letter day at OIR. The CoDx guidance has been finalized and, against all odds, FDA has announced that they're going to release the LDT draft guidance.

I was a naysayer on this recently and FDA has shown my pessimism to be premature. And I'm very happy to be wrong this time. Whichever way this breaks, it's long past time for the diagnostic industry to have this conversation in a meaningful way.

FDA published the final version of the CoDx guidance document today. The document is polished up a bit from the original version but doesn't hold any surprises for those of us that have been hip-deep in this world. The document has been improved with more specific examples and explanations. It is helpful, useful and still includes what I like to call the 'escape clause' for those cases where FDA needs to approve a drug or change the labeling of drug even in the absence of an approved CoDx.

FDA also notified Congress of their intent to publish a proposed framework for regulating LDTs. This notification includes the draft guidance document. If the proposed draft framework is indeed published, FDA intends to regulate the highest-risk portion of the LDT world and establish specific limits on what can be called an LDT. I'm still working through the document but at first and second read, it appears FDA has had ample time to prepare themselves for the arguments against regulating LDTs. Those opposed to regulation will need to step up their game and you can believe that process has already gotten started.

Lots more to say as we all get into this conversation. Whatever else happens, I'm looking forward to seeing the fireworks at the first public meeting.

Tags: CoDx, FDA, LDTs, Policy

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