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FDA LDT meeting, bigger than just DTCG!

Posted Jul 19 2010 6:34pm
At the FDA public hearing today , I began to hear a collective groan. The groan was from the LDT community that provide tests that are actually in clinical use today. You, see, this hearing is much more about LDT than it is about little 'Ol DTCG.

DTCG in fact was the perp walk that allowed LDT to now fall under question. For years, Home Brew labs up at Yale and Harvard and GeneDx and I could go on and on, went unscathed from FDA regs. Why? The tests were used by so few people and the case for harm was pretty weak.

Despite all of this, the FDA is now awoken and realizing it was asleep at the wheel here while the wagon train was being run by the Music Man ! You can tell from the agenda that there is one thing at stake here........the future of nearly ALL genetic testing.

If you look at the list of speakers it was a hodgepodge of diagnostic labs, testing advocacy groups, consulting firms that bring biopharma through the pipeline and something called OMBU. WTF is OMBU ?

Tomorrow is more of the same. Of course Wadsworth was there to represent some sanity in this process, thank god. But my big Gestalt from today's action is:

1. The FDA firnly believes it is time to get its act together in regulating genetic testing


3. The FDA regulates tests, not labs.

What does this mean.

Well I can tell you this. The FDA will regulate LDT and follow some line that it already has with things like AmpliChip.

I can also tell you, the LDT house is huge and a few little revolutionaries in DTCG have brought the entire house down. I am surprised that the genetic testing industry and academic labs didn't see this one coming. So many I know in the space were always pro DTCG, I warned them precisely against the regulatory scrutiny which LDT would face given "Oprah, Dr. Oz, Blimps, Open Bars and Trump"


They said, nawh, we are ok in this space and serve a need, why regulate us? I think in Genetech we just found the answer. How can we hold a corporation to a different standard than an academic lab? How can we hold a big company to a different standard from a small company? How can we justify that to the public? More importantly, to the court?

The answer: They can't.

The Sherpa Says: I don't think I could stand another moment of the FDA conference tomorrow. Instead I will play on loop C3PO saying "Please don't deactivate me"
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