Grail delivers final study results showing its blood test’s accuracy in spotting 50 different cancers

fiercebiotech.com ^ | June 25, 2021 | Conor Hale

[House Atreides]

The final results from a Grail study of its cancer-tracing blood test found it was accurate at detecting a range of different tumors at early stages—especially those more likely to be lethal and have fewer screening options.

Grail launched its prescription Galleri diagnostic in the U.S. earlier this month. The test is designed to help spot as many as 50 different cancers and uncover their original organ sites from a blood sample…

In a paper published in… cancer journal Annals of Oncology using data gathered from the company’s Circulating Cell-free Genome Atlas study, researchers found the test could detect cancer before symptoms developed, while offering an overall false-positive rate of 0.5%.

…The test relies on capturing and analyzing small pieces of DNA released by tumors into the bloodstream, with some cancers shedding more genetic material than others….

…In addition, the test was able to identify the tumors’ organ sites 88.7% of the time, giving clinicians a head-start in targeting the disease for treatment and helping them choose the most effective follow-up diagnostics.

The Galleri test does this by analyzing changes in the tumor DNA’s larger chemical structure, where clusters of attached compounds known as methylation groups form specific patterns that can be traced back to individual cancer sites. Grail said it expects to be able to turn around results within 10 business days.

Among people most likely to develop cancer, such as those between ages 50 and 79, researchers found the test had an overall positive predictive value of 44.4% and a negative predictive value of 99.4%.

…“Developing technologies that address this issue is the first step. Next steps will include the development of new therapeutic interventions,” André said. “In parallel, major efforts related to population awareness must continue, or all these efforts will not lead to transformation of outcomes."

[House Atreides]

Following its initial launch it is expected the Galleri test could be used to help screen as many as 50 million people, according to the DNA sequencing giant Illumina. The Galleri test was launched under a “CLIA waiver” under which waived tests are categorized as “laboratory examinations and procedures that have an insignificant risk of an erroneous result” - which is a pretty good standard in my book.

Grail will pursue the full bureaucratic FDA approval in 2023. Until it gets full FDA approval our health insurance plans wouldn’t cover the cost but we could likely use flexible spending accounts (which, unfortunately, I don’t have) to pay the cost.

Anyway, this is very good news, IMHO. I recommend going to the linked site as I was required to edit the extract down to only 300 words to post.

[BenLurkin]

bttt

[ProtectOurFreedom]

This could be excellent.

Let’s hope Elizabeth Holmes isn’t involved.

[Shadylake]

First thing I thought, another Edison machine. Hopefully not.

[hadrian]

“Let’s hope Elizabeth Holmes isn’t involved”
________________________________

Exactly my thoughts. “Too good to be true” usually is.

[ClearCase_guy]

Sounds a bit like Elizabeth Holmes and Theranos. Almost everyone thinks she was a complete fraud. But at least a few people think she had real science and The Powers That Be didn’t like her diagnostic tools. I believe she’s still tied in court and financially ruined.

[House Atreides]

“Sounds a bit like Elizabeth Holmes and Theranos. Almost everyone thinks she was a complete fraud….”
*********************************************************************
No, this is not the least like the Holmes fraud. And, IMHO, anyone who does NOT think Elizabeth Holmes is a complete fraud has a few screws loose. I think if Trump was still president he would be all over the FDA to make the approval process for this test a PRIORITY. But like all things government, they’ll take their sweet time to show how important they are.

[DAC21]

The Eyes!

This Fraud will probably never spend a day in jail.

[mrsmith]

2023 and not good at finding prostate cancer...
Guess I’ll be getting that biopsy after all.

[House Atreides]

“The Eyes!”
**************
The Voice!

[CrazyCatChick]

Here I’ve been waiting for med-beds like a sucker!

[Richard Axtell]

Some persons have a look in their eyes, that is both disturbing and disturbed. Marshall Applewhite, the founder of the Heaven’s Gate cult certainly comes to mind.

[House Atreides]

“2023 and not good at finding prostate cancer...
Guess I’ll be getting that biopsy after all.”
*************************************************
Yeah, its sensitivity (11.2%) at detecting prostate cancer signals in the blood sample (picked up 47 of 420 cancer cases) was pretty poor in their clinical trials. But it was much better at detecting other cancers such as pancreatic (83.7% picking up 113 out of 135) and lung cancer (74.8% picking up 302 out of 404 cancers). Remember, this test is meant as an early detection screen and the same blood sample is looked at for signals of a bunch of different cancers. And some of those cancers (e.g., pancreatic) have no existing screening tests and are usually found too late to be cured.

Since it will be several years until final “official” FDA approval, this screening test will initially only be taken by those who can self-pay. I hope President Trump’s doctors have him do the screening test once a year. It was bad enough to lose Rush, I don’t want us to lose Donald Trump.

https://www.annalsofoncology.org/article/S0923-7534(21)02046-9/fulltext

I wish you well with your biopsy.

[Vermont Lt]

Pancreatic Cancer early detection would increase the survival rate ten fold. It so horrifying now that ANY improvement would be huge.

[mrsmith]

Was being flippant. It seems there’s one part of my anatomy the VA cares about these days...

Thanks for the good wishes.

Looking forward to this test being employed.

[Mastador1]

Am I reading this right? Grail is hyping a study they conducted themselves? If that’s the case I’ll just wait till an outside independent study corroborates their self evaluation.

[FoundinTexas]

My husband had prostate cancer. MDAnderson doctors watched him over three years after his diagnosis. He chose surgery when they told him it was time to treat. Everything is great. Get the biopsy and keep positive.

[House Atreides]

Here’s a PDF version of the online article I linked to in post #13 above. It might be easier to read than the online version.

https://www.annalsofoncology.org/action/showPdf?pii=S0923-7534%2821%2902046-9

I posted this thread for the information of FReepers. Some may be interested in a multi-cancer early detection test and others won’t. My suspicion is that before the FDA finally gets around to formally approving the test (so insurance will cover its cost) an unknown number of lives will have been saved by the test’s early detection of cancers. Many more lives will be lost because other people did not have their cancers detected until the cancers were well advanced.

Since I have had several cancer deaths among both my and my wife’s extended families and my friends I will choose to have the screening test done for both my wife and myself. It’s a personal choice that fits our particular circumstances. Other folks will make a different choice and that’s OK.

[dkGba]

On the other hand I would also be very concerned about the rate of false positives. Indiscriminately ordering and getting this test will result in many people being denied health insurance, long-term care insurance, disability insurance, and life insurance -once the insurance companies get a hold of these results or require it as a condition of a policy you will be denied. Almost all of us have cancer cells in our body that doesn’t mean that we’re going to get cancer or die from cancer. However I have to certainly applaud to anything that will find pancreatic cancer early for sure-it’s nasty and disgraceful that we’ve barely made any progress against this awful killer that seems to be increasing in numbers

[mrsmith]

Thanks for the positivity.