Grail’s Galleri blood-based cancer detection test appears headed towards approval by the FDA after it passed a trio of votes from an advisory committee Sept. 23. However, a closer look at the votes — especially the split vote on the question of efficacy — and the debate that preceded it revealed just how much remains unsettled about what the test achieves. As this is the first test of its kind, with more to follow, how FDA chooses to regulate multiple aspects will reveal a lot about where the field is and what it still may need to prove.
And it may be the last chance science-minded regulators have to put some reins on Galleri before it gets out into a world where Grail has used its money and influence to tilt the market in its favor.
Alex Dickinson, a former Illumina executive who has built a large following on LinkedIn, in part due to his sharp critiques of Grail and Galleri, joined me to break the situation down.
Grail has spent years building up Galleri as a “multi-cancer early detection” test, but as Dickinson pointed out, “if you look at Grail’s [FDA approval] application, it doesn’t quantify either ‘early’ or ‘multi.’” The FDA advisory committee zeroed in on exactly that gap: what does “early” mean, and should Grail be allowed to use that word?
What the FDA decides to allow Grail to put on the test label and say in its advertisements may be as consequential as the approval itself. The decision will set precedent for Abbott/Exact Sciences’ Cancerguard test, Natera’s new test and Breakthrough device designation announced this morning, and others developing competing blood-based tests to promise to detect many cancers early.
Other key questions we try to address:
What do Galleri’s capabilities and shortcomings mean for the future of this kind of test?
How might the FDA regulate them in the future?
What impacts will they have on the US healthcare system?
You can also listen on Apple Podcasts and Spotify
Show Notes
Alex Dickinson’ LinkedIn Feed
Gilbert Welch STAT Op-ed
AdCom Vote Explanation Segment Transcript:
My story for GenomeWeb on Grail disclosing that the NHS-Galleri trial not meet its primary endpoint (Paywall)
David Cameron NHS/Grail/Illumina
https://www.bbc.com/news/business-58146567
BMJ investigation into Grail’s NHS-Galleri trial: “Galleri promises to detect multiple cancers—but new evidence casts doubt on this much hyped blood test”
Grail’s $15 million in lobbying:
Grail participation in RFK Jr.-linked event, first reported by Bloomberg (paywall) and also in the Los Angeles Times.
NHS Oncologists’ Letter to The Lancet: “GRAIL-Galleri: why the special treatment?”
Dan Swerdlow (Radiologist, Georgetown University) quote from AdCom meeting on the burden on the healthcare system for follow-up testing:
“I’m also concerned about the ability to deal with what are we going to do with all the positive tests that come out of this and everything else that’s going to get approved. For instance, you know, a lot of this stuff is solid organ tumors which [are going to require] imaging to confirm and a lot of the rest will require endoscopy and simply there aren’t enough physicians to do this.
We already don’t have enough trained endoscopists in this country to do the routine screening colonoscopy that needs to be done in this country and there large areas of this country where there is no access to anybody who’s trained to do endoscopy.
By the same token there’s a massive shortage of radiologists in this country estimated at 7,500 which, if my math is correct, is about 13 years of graduating residency classes. The expected radiology shortfall is going to last for 30 years.
It’s one thing for one company to start this, but when they all start coming online, they’re not going to get read in any timely fashion because there just simply aren’t enough bodies to go around further.
The idea that this is going to appeal to the rural and underserved communities. It’s a beautiful idea, totally in favor of it, but those rural communities don’t have MRIs, don’t have PET CTs, not for long distances, and [there are] CAT scanners around, but there’s nobody going to be around to read them. And it’s not the imaging test that produces the finding, it’s the radiologist who’s interpreting that test and there are not enough of us and it’s not going to change anytime soon.”
