5 ms·
Galleri test: Exciting results from blood test for 50 cancers
- defrost 1y agoExciting results from blood test for 50 cancers (Oct, 2025) The trial followed 25,000 adults from the US and Canada over a year, with nearly one in 100 getting a positive result. For 62% of these cases, cancer was later confirmed. Lead researcher Dr Nima Nabavizadeh, associate professor of radiation medicine at Oregon Health & Science University, said the data showed that the test could "fundamentally change" their approach to cancer screening. ~ https://www.bbc.com/news/articles/c205g21n1zzo https://www.bbc.com/news/articles/c205g21n1zzo A year ago: Galleri promises to detect multiple cancers—but new evidence casts doubt on this much hyped blood test (August 2024)) The NHS is currently running a £150m trial of the test, funded by Grail and involving more than 100 000 participants in England. ... Documents leaked to The BMJ indicate that the criteria being used, unpublished until now, are unsuitable to justify a new national screening programme aimed at saving lives. They show that even Mike Richards, the chair of the independent UK National Screening Committee, has privately voiced “serious concerns” to Amanda Pritchard, NHS England’s chief executive, about the trial and its ability to provide sufficient evidence “on whether the benefits of testing outweigh any potential harms and at reasonable cost.” ~ https://www.bmj.com/content/386/bmj.q1706 https://www.bmj.com/content/386/bmj.q1706 Company site: https://www.galleri.com/what-is-galleri/types-of-cancer-detected https://www.galleri.com/what-is-galleri/types-of-cancer-dete...
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- odie5533 1y agoSo 250 came back positive. What about the 24,750? Are they confirmed cancer free?
- MPSimmons 1y ago>The test correctly ruled out cancer in over 99% of those who tested negative. Forgive me if I'm wrong, but isn't this the textbook example of understanding false negatives in testing people at scale?
- more_corn 1y agoNeato
- HardCodedBias 1y agoMy doctor requested one for me, and I just got it in the mail (USA), which is nice for me. I suspect that this will remain a niche product. It would, in theory, be applicable to most people on earth. Such wide spread screenings simply aren't viable in a world of massive compliance costs and subsidized health care. It took an act of god for simple COVID testing to become somewhat inexpensive. I look forward to getting this test every few years until it is killed by our regulatory apparatus.
- johnnyApplePRNG 1y agoDoctors can simply request these now? The article made it read like it was some trial that just completed. Does anyone know if (or when) these are regularly available in Canada? And the costs associated?
- bitwize 1y agoIt could be that GP participated in a study, or simply had a cool doctor willing to pull a few strings.
- epistasis 1y agoThey always could! Diagnostics are a bit different than therapeutics, which need that big Phase 3 trial before you can start selling a new therapy. There are two regulatory regimes for diagnostics in the US: 1) Lab developed tests (LDTs) licensed under the CLIA legislation (I think from the 1980s). These are verified by a Lab Director with a professional license in diagnostics, that allows them to sign out clinical results from the test. There are professional organizations that perform regular inspections of the lab, its condition, its paperwork, its tests, the SOPs, and the internal validations that have been performed at the lab director's direction to assess performance of the tests. These are limited to a single site, the kits for the test can not be sold except for Research Use Only, and if a second site wants to start doing a similar test the lab director at the other site needs to do all the same validation all over again as at the first site. 2) FDA approval for diagnostic medical devices. These can be simple and straightforward for Class 1/2 devices, which do not directly provide medical advice but mere physical readouts (to greatly bastardize the distinction between Class 1/2 and 3). Or the device approval can be quite complex for Class 3 devices, and would require a huge trial like the one described here. If you want to sell the device for others to use, rather than just testing as service, you want to go this route. Though there are still single-site "devices" especially for DNA sequencing tests, that want the FDA label. Neither of these will result in getting reimbursement for a test. For that, you need to pursue coverage determinations from all the payers, basically one on one. For complex sequencing tests like this that mostly affects older populations, getting CMS coverage (Medicare) can pave the path for others. For other conditions... well... get all your trials and papers together and hope that your patient population is super sympathetic or you can show the insurance company some savings. A large clinical trial like this one can help with getting coverage for the test, but it has to either show a big medical benefit, or show economic benefits within five years for the payor. Or ideally both. Early cancer detection has potential for this, but I have not heard optimistic things up until now at Galleri's chance for reimbursement any time soon.
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- evantbyrne 1y agoNot convinced the Grail approach is safe and effective for low-risk cohorts given the false-positive rate. Follow-up diagnostics are not risk-free.
- ggm 1y agoThe non-invasive followup for people with positive test results would knock out a lot of the false-positives. At least, thats what I understand of "the usual result of a positive test result for a serious illness, is that a repeat test does not confirm it" That said, at what level of risk of follow up diagnostic would you baulk? Any procedure which requires a general is bad news, and if you are over 70 its a lot more bad.
- evantbyrne 1y agoTheir advertised sensitivity and specificity put them in the ballpark of what other liquid biopsies advertise. The ones I know of target high-risk cohorts where the benefits of other screenings already outweigh the risks of taking them. It doesn't make sense for the average person to be getting periodic full chest CT scans for instance, but it might for a decades-long smoker.
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- nradov 1y agoSure, that's a concern. But for screenings like this the ultimate metric is all-cause mortality (perhaps adjusted for costs and quality of life). It will take several years before we have a clear signal on that.
- tptacek 1y agoI'm a tedious broken record about the fact that the base rate of most cancers means that extraordinarily-accurate-seeming screening tests have surprisingly untenable false positive rates. Like, a 99% accurate test for liver cancer might be almost worthless: because the base rate is so low, 99% of positives will be false. And a false positive screening result is not innocuous: it incurs costs in a variety of different ways, including human health.
- para_parolu 1y agoWhat if you just do these testa every few days? Would this minimize error rate?
- Nifty3929 1y agoProbably not. They are not likely independent. Whatever it is about you that caused the false positive yesterday might likely cause it tomorrow.
- throwup238 1y agoNo, the factors causing the false positives are usually correlated. The most common cause is mutations causing unrelated proteins to mimic an epitope (binding site) of the biomarker protein. Another cause is analytical interference where some other molecule absorbs the wavelength used to measure the assay. Running the test using multiple different labs helps eliminate contamination and handling errors but most false positives are due to genetics and long term environmental factors.
- raffraffraff 1y agoBut if you got one test saying "Detected a fragment of pancreatic cancer DNA" two days later another saying "Didn't see any cancerous DNA fragments" what would the actual effect on the doctor or patient be? Who'll take the risk and say "the first was a false positive"? Also, these tests are a grand a pop if I'm reading it directly (which I may not be)
- para_parolu 1y ago
- yieldcrv 1y ago> Crucially, three-quarters of cancers detected were those which have no screening programme such as ovarian, liver, stomach, bladder and pancreatic cancer. That's exciting. The first step of many. The bar is so low because it remains to be seen if this earlier detection prevents deaths. And of course we still don't know the root causes or triggers, which promotes the same thing occurring a few years later. Remission is not solved, we need cure still.
- 7e 1y agoThis test isn’t reliable for many cancers until they reach stage 3 or 4. Better than nothing, but it will give many people a false confidence that they don’t have cancer.
- missedthecue 1y agoIs it better than the status quo? How many people know they have stage 1 cancer anyway?
- blindriver 1y agoAs opposed to…? If they don’t take the test, then presumably they also think they don’t have cancer.
- searine 1y agoI did this recently. Paid out of pocket, but it was worth it for the peace of mind. It's not perfect but it's easy/fast and a good way to screen for big problems.
- smt88 1y agoIt's possible (if not likely) that paying for this test made you more likely to die. There are two mechanisms for this: 1) You could develop cancer tomorrow, notice the symptoms, and assume it's not worth getting screened again because you were just supposedly cleared of cancer. A common logical fallacy for our human brains is that we think, "Oh, I just got a test, so it's less likely I have cancer today," which is not how probability works. 2) You could have gotten a false positive, which would have led to unnecessary additional screening. Many methods of cancer screening have some risk, whether from anesthesia, infection, or further false positives leading to unnecessary treatment.
- searine 1y agoHyperbole. I am not going to avoid any reasonable treatment/screen because of it. It was intended to catch asymptomatic cancer. Additional invasive screenings are voluntary and like all treatments they carry risk. I weigh all treatments based on their risks at the time. For everyday people increased screening of all types has risks, but overall the benefits massively outweigh the risks. If I was a frail 80yo, I might see the risk profile differently. In my career I've encountered many people who "don't want to know" about medical tests of any kind. I'm not one of those people. Minimally invasive screens early and often please.
- smt88 1y ago> For everyday people increased screening of all types has risks, but overall the benefits massively outweigh the risks. This is just not how math works, and it's why we still need doctors to order tests -- to protect people from themselves. You clearly don't know what you don't know, but you have a huge amount of confidence that you do, apparently. Here's a list of different types of cancer screenings and where the risk/benefit falls: https://publichealth.jhu.edu/2023/balancing-the-benefits-and-risks-of-cancer-screening https://publichealth.jhu.edu/2023/balancing-the-benefits-and... The risk of any cancer screening has to be calculated with variables like: - how risky is the test? - what are the risks of a false positive? - how does a true negative affect the person's behavior in the future? - what is the likelihood that the patient has asymptomatic cancer, based on risks like genetics and age? - how difficult is the cancer to treat in different stages? Without looking at all of those things, you don't know if the test is going to increase or decrease all-cause mortality risk.
- evolighting 1y agocfDNA-based tests have received heavy investment, mainly because they are easy to market. It’s not a false promise — rather, a technology that is still far from perfect because of existing technical barriers.
- chaostheory 1y agoFunction Health offers this test as an $899 add-on to their subscription which is $499. It’s on sale a few times a year at $365. I’m about to order it.
- raffraffraff 1y agoParty pooper? https://pmc.ncbi.nlm.nih.gov/articles/PMC11886625/ https://pmc.ncbi.nlm.nih.gov/articles/PMC11886625/