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"
4 comments:
It's really simple. FDA wants more user fees and Genentech wants to regulate startups and academic labs out of existence.
This has NOTHING to do with patient welfare.
This is a giveaway to multinational corporations at the expense of all of us.
Maybe,
Or maybe it is just a reminder to Venture Capital to have their SH!T together when they invest in this space and not exaggerate and use deceptive marketing.......
The historical problem with LDTs has always been that self-validation with no standard is a free pass to build a test any way they please. I know - I was senior management at one of the specialty oncology labs completely skirting the law by validation...with TWENTY replicates. Compare that with the ~2,000 replicates the kit manufacturer I work for now must do to validate.
The present and increasing future reason we have an issue has nothing to do with big vs small or even FDA regulating that which it has always had the right. Remember: CLIA regulates labs, not tests; FDA has always overlooked lab tests in spite of having the responsibility.
This is all about risk and claims. Providing a test for the presence/quantity of a biomarker for which there is only one clinical use - predicting response to drug - but providing it as an LDT without claiming to predict response is allowed today. The rules say prediction must be clinically demonstrated and predictive tests must be registered. The number of labs that offer tests without claims for markers and thereby avoid an requirement for clinical proof is quite large. Most importantly. the manufacturers that actually go to the extreme difficulty to establish clinical proof will be undercut by being compliant with FDA compared to the labs that make a recipe of their own for that marker yet never establish the the test is equivalent and certainly never do the clinical studies.
This there is no risk? Wait until the first class-action suit naming a lab, manufacturer and drug company for a test that made the wrong call on mutation status.
Bottom line: The labs skirt the law because no one enforces it. Manufacturers adhere to the law and sell products to the very same labs. Motivation to make an LDT - better margin. Motivation to hate regulation - lower margin because they will need to be properly validated which actually requires investment in product development beyond a tech building tests over the weekend.
David M, no one accepts a diagnostic without published papers. Not MDs, not insurance.
At the end of the day the MD and insurer will look at the sample size and agree to prescribe or not.
If you say the MDs are not qualified I will disagree and further say the same charge can be applied to bureaucrats.
Every rare variant in the genome cannot be validated on 2000 samples. We need a complete rethink and the FDA is moving in completely the wrong direction. No centralized agency is possibly as smart as millions of distributed MDs and PhDs.
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