Friday, June 24, 2011

If you were expecting another round of the LDT wars at yesterday's Next Generation Sequencing meeting, I have bad news for you: it was more of a collegial academic conference experience than many of us expected it would be.

In fact, the meeting may have demonstrated something a bit surprising in today's environment: the potential to find common ground between federal regulators and the people on the cutting edge of medical product development.

To hear some tell it, FDA and industry are locked in an all-out death match to determine the future of medicine. To sit in yesterday's public meeting, I have to wonder if this issue isn't just going to fix itself soon enough.

The meeting began, fittingly enough, with a retelling of the classic horse manure problem from the dawn of the 20th Century. The obvious lesson of this modern parable is that it's difficult to see that the solution to today's problems may rest in developments that already exist, but are not yet considered practical.

The brewing RUO crisis may be another horse manure problem. It is, in some respects, totally intractable given current assumptions. Perhaps, though, it is the very intractability of current assumptions that will lead to them being swept aside.

One thing that jumped out at me during the meeting is that we may be talking about a whole new regulatory paradigm when it comes to next-gen sequencing. The current assumptions about clearances being driven by intended use may not be practical (or even meaningful) when it comes to this technology. It's way too early to say anything for sure, but I'm pretty sure that what we were talking about yesterday was the possibility of allowing instrument-only clearances.

Instrument-only clearances were previously a thing of legend and myth, like Santa Claus or the Loch Ness Monster. I think FDA might be ready to consider the idea that such a thing should exist, however.

A policy that allows instrument-only applications is no small thing and could easily be a game-changer. Giving instrument manufacturers a reasonable and attractive path to clearance could alleviate a lot of angst around the new RUO guidance and give key players a strong nudge toward adopting QSR.

The door might be open, but we need to be very careful we don't slam it on ourselves. We need to nurture this opening and coax it to fruition. Yesterday's public meeting was an excellent example of a collegial, fact-driven interaction between regulators and industry. We need to build on that good will and cut it out with the name-calling, the accusations of stifling innovation and the public accusations of driving up body counts.

FDA truly isn't opposed to exciting new technology, they just want it to prove what its value is and that the benefits and risks of introducing it into clinical practices are evaluated. That will be no small feat, as was also clear from yesterday's meeting. But we're all on the same side on this one and should bear that in mind as we usher in this quantum leap in molecular diagnostics.

Tags: FDA, Industry, LDTs, Policy, RUO

Other Blog Authors

Dylan Reinhardt
Dave Kern
Steve Gutman
Jo-Ann Gonzales

Recent Blog Posts

The Staple That Changed an Industry LDT regulation and the perils of challenging Eminem to a rap battle
FDA Releases the Kraken Whichever way this breaks, it's long past time to have this conversation in a meaningful way
Illumina Acquires Myraqa Acquisition Strengthens Illumina’s Clinical Readiness
The Spirit of GLP A Best Practice for IVDs
Process Performance Qualification (PPQ) Lots So, how many lots are required?
The Case for Risk-based Monitoring Better the devil you know...
Form Follows Function OIR Reorganizes to Meet the Advancing Wave of Molecular Diagnostics
CDRH Unveils New PMA Guidance Documents Attention shoppers, it's two-for-one day!