Deja vu to PSA, anyone? Just because a test is there does not mean it should be used for widespread screening. And this particular test should not be allowed for general use based on a single study funded by the same people looking to make serious money if the test turns out to be marketable. Hopefully the regulators actually do their job and disallow this test to market without multiple other independent studies (preferably from other countries, totally unaffiliated, with no profit motive) confirming its results.
Repeating studies is not sexy and is not career making. But, isn't this why we have public funding for such research?
"Just because a test is there does not mean it should be used for widespread screening" I think this is one of the best things I've read recently. Screenings are only helpful if they do not result in too many false positives and too much overtreatment. And as you give in your example, the PSA is probably the gold standard for a test that probably does both.
Also, anything that is reported to have a 100% rate of success I'm just as skeptical of as the author.
I do think it's important to challenge assumptions about what causes cancer and how our bodies handle cancer as well. There seem to be some narratives that may not be entirely true that are the predominant ones in medicine right now.
Due to the fact that I was diagnosed with dermatomyositis my rheumatologist insisted on follow up studies. After endoscopy, colonoscopy, two MRIs, visits with pulmonology, dermatology and oncology I was told things were fine. However, a much more informed dermatologist at our local medical center, with a veritable encyclopedic knowledge of dermatomyositis, insisted I see an oncologist on the medical center staff. This, rather young, oncologist reviewed all the findings and agreed they revealed nothing to worry about. However, he strongly recommended that I have a Galleri panel performed, which, of course, insurance wouldn’t cover. I followed his advice and the test came back positive for a head and neck cancer. Subsequently, ENT found an HPV associated SCCa on the base of the tongue. (Somewhat ironic since my specialty is oral pathology). After a course of chemo and radiation, PET scan shows no evidence of tumor.
So, while my scientific background compels me to agree with your surmise concerning the accuracy of the test I, for one, am eternally grateful that this young oncologist pushed me to have it done. Skepticism is the chastity belt of the intellect (and thusly science) George Santayana said, but one must be cautious not to allow for rigidity to acceptance of novel ideas. Let’s allow the science to play out. I strongly suspect the Galleri test will become routine in the future.
Your situation was completely different than most people who might be subjected to this test. You had good reasons to think that you might have had cancer. The test just told you where to look. Your prior probability was much higher than the general population, and that has to be taken into account when evaluating the performance of the test.
This test has great potential to cause many problems if it is widely used, even if it performs as advertised, which I doubt that it will. There are some cancers that are best left undiscovered. Two that come to mind are most papillary thyroid carcinomas and low grade prostate cancers in older men. We need to think about this carefully before rolling it out.
Tests like the Galleri will definitely have some incredible saves! And I, for one, having just come through treatment for a head and neck cancer, wouldn't have minded having that sucker picked up a few months earlier. However... by the time that tumor would have started to affect speaking or swallowing, it's possible your treatment and prognosis would not have worsened at all. It's also possible/probable that if I did a Galleri test every year, it would have been negative for my stage II cancer, and I might have pushed off seeking care for my trismus even longer than I did with that false reassurance! This is very tricky business, and longer term prospective studies are critical.
As to Dr Finfer's point... assuming you did not wade through the 2021 article, you somehow managed to highlight two of the "saves" HrC made for people with an intermediate HrC score in the 1000 person study. One person was followed and found to have a localized prostate cancer (Gleason not supplied) and another a borderline thyroid cancer... both examples of quasi-cancers that maybe should not have been found in the first place.
I didn’t wade through the entire paper, but I’ve been following the PSA story since I had early onset prostate cancer picked up by a PSA. It turned out later that I was high risk and should have been screened. Long story.
The other thing that came to mind was a story out of South Korea. They instituted a population-wide cancer screening program, and somehow thyroid ultrasounds to screen for cancer went along for the ride. There was a massive increase in thyroid cancer diagnoses and no increase in the death rate.
This is probably the first thing that I thought of when I saw the headline.
I should add that I am not saying that the test has no value. I’m saying that there’s no way to have a test that’s 100% sensitive and 100% specific. There’s something wrong with the claim.
In patients in particular with high prior probability, there may well be value in localizing hard to find malignancies.
I fully agree this technology has some limited utility now, and probably more if/when tests improve and real screening trial gets done. This particular test... yes. There's no way to have a test 100% sensitive and specific, *especially* in the realm of a universal cancer marker with hard numerical cut-offs -- it just makes no sense! How did the authors think they could slide through with this? How did the publishers let this fly? Why did I not notice this in 2021? So many questions. But frustrating. I can't stand when "science" is allowed to defy common sense.
While the development of a blood test that claims to have 100% accuracy in detecting various cancers is certainly intriguing, it's important to approach such claims with a healthy dose of skepticism. As the author points out, nothing in medicine is perfect, and more studies with independent verification are needed before fully endorsing the HrC test.
On another note, for those seeking ivermectin, it's available at ivermectin4sale.uk. However, it's crucial to consult with a healthcare professional before using any medication, as they can provide guidance on appropriate use and potential risks. Let's keep our focus on evidence-based treatments and maintain a critical eye on emerging medical breakthroughs.
I appreciate your balanced perspective on the potential of the HrC blood test for detecting cancers. It's crucial to maintain a healthy skepticism and wait for further independent studies before embracing such claims wholeheartedly.
Additionally, thanks for sharing the information on where to find ivermectin. Your advice to consult with a healthcare professional before using any medication is essential, as they can guide us on the correct usage and potential risks. Let's continue prioritizing evidence-based treatments and staying informed about new medical advancements.
Since cellular elements that are potentially neoplastic/malignant are present in any one individual from birth to death, the ability to detect some "signal" should surprise no one. Intrinsic molecular and immunoprotective mechanisms to control such events are extremely powerful. Of course a positive "test" is no a clinical disease (see COVID testing fiasco 2020-2022). These claims are sure to be overturned. But in the meantime, they are the next pollen for the Theranos bees.
One needs a prospective study before any results can be taken seriously. GRAIL (which was not from Mayo labs, it is a spin-off from Illumina) has done large multi-center prospective studies to prove their sensitivity and specificity numbers. I agree that if you have a genetic risk for breast and ovarian cancer (say) and do test positive fro BRCA1/BRCA2 genes, it may make sense for you to get the Galleri test and from that perspective, it could be useful. It could also be a reasonable substitute for colonoscopy (which are really really expensive).
Great article and I love your skepticism. I googled this test after reading about it in New York Post and was very curious of public response. I actually work for another company that screens for cancer with a blood test. My name is Bulat Beksultanov and I am just a graphic designer not an actual medical professional. Today, market is saturated with so many tests that claim that they can detect cancer early that we may look just like one of them. But we developed a technology (a filter) that catches a whole CTCs from your blood stream and give it to a board certified pathologist to write a report. No Ai no technological breakthrough mambo jumbo, just an old straight biopsy report. We can also trace the tissue of origin with a different staining technique to save patients from anxiety of an unknown cancer somewhere in their body. I think, if you a curious about tests that actually work and CAN detect cancer at Stage zero you should check out Cancer Check Labs, we have a paper published on detecting a Stage 0 and Stage 1 breast cancer. (it is published on our website) I don't know if you can post links here, but if you are interested I can give more details.
I’m SO curious about this debate - MCEDs exist and are likely going to get more accurate (sensitivity for early cancers) and numerous. I now understand the doctors reservations/point of view but where does this leave patients?
Particularly because it does appear that some cancers, specifically GI cancers, are increasing in people under 50. These cancers are hard to catch early and have no recommended screening in this age group. I keep reading stories (and unfortunately know a few people) who are in their late 30s and 40s, no known genetic risk factors and healthy diet/exercise often who have been diagnosed with colon cancer/gastric cancer.
Their outlooks are dismal.
If we never figure out what is causing this increase in healthy younger adults (doesn’t seem like there’s a ton of money/research going into this), do we just accept the risk that we could also get these cancers even if we have no known risk factors? That’s hard to stomach when there are tests out there right now that could diagnose these cancers early. I’m just confused about what risk we as patients should accept given increasing cancer rates
Also it really seems like metastatic cancer will never be treatable and that emerging cancer vaccines will likely only work meaningfully on patients diagnosed in early stages. Given this, isn’t early cancer detection via MCEDs the only logical direction to go in?
I agree with your skeptical instinct on the HrC blood test. Send too good to be true, but more data should flesh it out.
One thought about the Galleri test, and the concern for false positive. Rather than begin the myriad of testing with one result, would probably repeat the test. If it also came back positive, would significantly increase the likelihood of the need to do a search, if negative, May repeat once more, but would sleep easier. Cost should come down over time.
So now 2-3 tests for every positive? And if it's +-+ you go down the rabbit hole? But +-- you tell yourself it's ok to sleep at night without knowing why that first test was positive? Sigh. This is why Mayo needed to spend the $ to run a prospective trial of their technology rather than take the money and run. The only way to know what to do with a positive and negative test is to follow outcomes from a prospective trial. In terms of locating cancers, even 2-3 years of follow-up would be enough to know how to interpret different results (did +s with a negative initial work-up end up developing cancer? if you run this every 3-6 mo are you picking up cancers at earlier stages to the point of clinical relevance vs standard screening?). We're left with more unknowns than knowns about practical use of the test.
Well. False positives happen. In my humble opinion, it is not excactly nec to know why a false positive occurred. They happen.
For +,- I think that would be good enough for me and most people, esp if being followed every 6 mo for high risk depends on the rate of false neg.
You mention the issue of screening every 3-6 months potentially is needed to catch highly malignant cancers, and seem to make the argument that unless one is screening that often, it is useless. That may be the case, but that would pretty much eliminate every screening test we have. I am going to assume you do not think we should just wait until a cancer makes itself clinically. Not a perfect test by any measure, but seems like a solid advance. Will see how the retrospective data looks in a few years.
Deja vu to PSA, anyone? Just because a test is there does not mean it should be used for widespread screening. And this particular test should not be allowed for general use based on a single study funded by the same people looking to make serious money if the test turns out to be marketable. Hopefully the regulators actually do their job and disallow this test to market without multiple other independent studies (preferably from other countries, totally unaffiliated, with no profit motive) confirming its results.
Repeating studies is not sexy and is not career making. But, isn't this why we have public funding for such research?
"Just because a test is there does not mean it should be used for widespread screening" I think this is one of the best things I've read recently. Screenings are only helpful if they do not result in too many false positives and too much overtreatment. And as you give in your example, the PSA is probably the gold standard for a test that probably does both.
Also, anything that is reported to have a 100% rate of success I'm just as skeptical of as the author.
I do think it's important to challenge assumptions about what causes cancer and how our bodies handle cancer as well. There seem to be some narratives that may not be entirely true that are the predominant ones in medicine right now.
https://mattcook.substack.com/p/happy-to-horrified-the-lies-of-serotonin
could you elaborate on the PSA deja vu please?
Due to the fact that I was diagnosed with dermatomyositis my rheumatologist insisted on follow up studies. After endoscopy, colonoscopy, two MRIs, visits with pulmonology, dermatology and oncology I was told things were fine. However, a much more informed dermatologist at our local medical center, with a veritable encyclopedic knowledge of dermatomyositis, insisted I see an oncologist on the medical center staff. This, rather young, oncologist reviewed all the findings and agreed they revealed nothing to worry about. However, he strongly recommended that I have a Galleri panel performed, which, of course, insurance wouldn’t cover. I followed his advice and the test came back positive for a head and neck cancer. Subsequently, ENT found an HPV associated SCCa on the base of the tongue. (Somewhat ironic since my specialty is oral pathology). After a course of chemo and radiation, PET scan shows no evidence of tumor.
So, while my scientific background compels me to agree with your surmise concerning the accuracy of the test I, for one, am eternally grateful that this young oncologist pushed me to have it done. Skepticism is the chastity belt of the intellect (and thusly science) George Santayana said, but one must be cautious not to allow for rigidity to acceptance of novel ideas. Let’s allow the science to play out. I strongly suspect the Galleri test will become routine in the future.
Your situation was completely different than most people who might be subjected to this test. You had good reasons to think that you might have had cancer. The test just told you where to look. Your prior probability was much higher than the general population, and that has to be taken into account when evaluating the performance of the test.
This test has great potential to cause many problems if it is widely used, even if it performs as advertised, which I doubt that it will. There are some cancers that are best left undiscovered. Two that come to mind are most papillary thyroid carcinomas and low grade prostate cancers in older men. We need to think about this carefully before rolling it out.
Tests like the Galleri will definitely have some incredible saves! And I, for one, having just come through treatment for a head and neck cancer, wouldn't have minded having that sucker picked up a few months earlier. However... by the time that tumor would have started to affect speaking or swallowing, it's possible your treatment and prognosis would not have worsened at all. It's also possible/probable that if I did a Galleri test every year, it would have been negative for my stage II cancer, and I might have pushed off seeking care for my trismus even longer than I did with that false reassurance! This is very tricky business, and longer term prospective studies are critical.
As to Dr Finfer's point... assuming you did not wade through the 2021 article, you somehow managed to highlight two of the "saves" HrC made for people with an intermediate HrC score in the 1000 person study. One person was followed and found to have a localized prostate cancer (Gleason not supplied) and another a borderline thyroid cancer... both examples of quasi-cancers that maybe should not have been found in the first place.
I didn’t wade through the entire paper, but I’ve been following the PSA story since I had early onset prostate cancer picked up by a PSA. It turned out later that I was high risk and should have been screened. Long story.
The other thing that came to mind was a story out of South Korea. They instituted a population-wide cancer screening program, and somehow thyroid ultrasounds to screen for cancer went along for the ride. There was a massive increase in thyroid cancer diagnoses and no increase in the death rate.
This is probably the first thing that I thought of when I saw the headline.
I should add that I am not saying that the test has no value. I’m saying that there’s no way to have a test that’s 100% sensitive and 100% specific. There’s something wrong with the claim.
In patients in particular with high prior probability, there may well be value in localizing hard to find malignancies.
I fully agree this technology has some limited utility now, and probably more if/when tests improve and real screening trial gets done. This particular test... yes. There's no way to have a test 100% sensitive and specific, *especially* in the realm of a universal cancer marker with hard numerical cut-offs -- it just makes no sense! How did the authors think they could slide through with this? How did the publishers let this fly? Why did I not notice this in 2021? So many questions. But frustrating. I can't stand when "science" is allowed to defy common sense.
While the development of a blood test that claims to have 100% accuracy in detecting various cancers is certainly intriguing, it's important to approach such claims with a healthy dose of skepticism. As the author points out, nothing in medicine is perfect, and more studies with independent verification are needed before fully endorsing the HrC test.
On another note, for those seeking ivermectin, it's available at ivermectin4sale.uk. However, it's crucial to consult with a healthcare professional before using any medication, as they can provide guidance on appropriate use and potential risks. Let's keep our focus on evidence-based treatments and maintain a critical eye on emerging medical breakthroughs.
I appreciate your balanced perspective on the potential of the HrC blood test for detecting cancers. It's crucial to maintain a healthy skepticism and wait for further independent studies before embracing such claims wholeheartedly.
Additionally, thanks for sharing the information on where to find ivermectin. Your advice to consult with a healthcare professional before using any medication is essential, as they can guide us on the correct usage and potential risks. Let's continue prioritizing evidence-based treatments and staying informed about new medical advancements.
Since cellular elements that are potentially neoplastic/malignant are present in any one individual from birth to death, the ability to detect some "signal" should surprise no one. Intrinsic molecular and immunoprotective mechanisms to control such events are extremely powerful. Of course a positive "test" is no a clinical disease (see COVID testing fiasco 2020-2022). These claims are sure to be overturned. But in the meantime, they are the next pollen for the Theranos bees.
I agree. The most likely cause of results like this is fraud. I will look for Retraction Watch’s article on this in the future.
One needs a prospective study before any results can be taken seriously. GRAIL (which was not from Mayo labs, it is a spin-off from Illumina) has done large multi-center prospective studies to prove their sensitivity and specificity numbers. I agree that if you have a genetic risk for breast and ovarian cancer (say) and do test positive fro BRCA1/BRCA2 genes, it may make sense for you to get the Galleri test and from that perspective, it could be useful. It could also be a reasonable substitute for colonoscopy (which are really really expensive).
Hi there!
Great article and I love your skepticism. I googled this test after reading about it in New York Post and was very curious of public response. I actually work for another company that screens for cancer with a blood test. My name is Bulat Beksultanov and I am just a graphic designer not an actual medical professional. Today, market is saturated with so many tests that claim that they can detect cancer early that we may look just like one of them. But we developed a technology (a filter) that catches a whole CTCs from your blood stream and give it to a board certified pathologist to write a report. No Ai no technological breakthrough mambo jumbo, just an old straight biopsy report. We can also trace the tissue of origin with a different staining technique to save patients from anxiety of an unknown cancer somewhere in their body. I think, if you a curious about tests that actually work and CAN detect cancer at Stage zero you should check out Cancer Check Labs, we have a paper published on detecting a Stage 0 and Stage 1 breast cancer. (it is published on our website) I don't know if you can post links here, but if you are interested I can give more details.
Cheers,
Bulat
I’m SO curious about this debate - MCEDs exist and are likely going to get more accurate (sensitivity for early cancers) and numerous. I now understand the doctors reservations/point of view but where does this leave patients?
Particularly because it does appear that some cancers, specifically GI cancers, are increasing in people under 50. These cancers are hard to catch early and have no recommended screening in this age group. I keep reading stories (and unfortunately know a few people) who are in their late 30s and 40s, no known genetic risk factors and healthy diet/exercise often who have been diagnosed with colon cancer/gastric cancer.
Their outlooks are dismal.
If we never figure out what is causing this increase in healthy younger adults (doesn’t seem like there’s a ton of money/research going into this), do we just accept the risk that we could also get these cancers even if we have no known risk factors? That’s hard to stomach when there are tests out there right now that could diagnose these cancers early. I’m just confused about what risk we as patients should accept given increasing cancer rates
Also it really seems like metastatic cancer will never be treatable and that emerging cancer vaccines will likely only work meaningfully on patients diagnosed in early stages. Given this, isn’t early cancer detection via MCEDs the only logical direction to go in?
Would love a doctors opinion on all this!
I agree with your skeptical instinct on the HrC blood test. Send too good to be true, but more data should flesh it out.
One thought about the Galleri test, and the concern for false positive. Rather than begin the myriad of testing with one result, would probably repeat the test. If it also came back positive, would significantly increase the likelihood of the need to do a search, if negative, May repeat once more, but would sleep easier. Cost should come down over time.
So now 2-3 tests for every positive? And if it's +-+ you go down the rabbit hole? But +-- you tell yourself it's ok to sleep at night without knowing why that first test was positive? Sigh. This is why Mayo needed to spend the $ to run a prospective trial of their technology rather than take the money and run. The only way to know what to do with a positive and negative test is to follow outcomes from a prospective trial. In terms of locating cancers, even 2-3 years of follow-up would be enough to know how to interpret different results (did +s with a negative initial work-up end up developing cancer? if you run this every 3-6 mo are you picking up cancers at earlier stages to the point of clinical relevance vs standard screening?). We're left with more unknowns than knowns about practical use of the test.
Well. False positives happen. In my humble opinion, it is not excactly nec to know why a false positive occurred. They happen.
For +,- I think that would be good enough for me and most people, esp if being followed every 6 mo for high risk depends on the rate of false neg.
You mention the issue of screening every 3-6 months potentially is needed to catch highly malignant cancers, and seem to make the argument that unless one is screening that often, it is useless. That may be the case, but that would pretty much eliminate every screening test we have. I am going to assume you do not think we should just wait until a cancer makes itself clinically. Not a perfect test by any measure, but seems like a solid advance. Will see how the retrospective data looks in a few years.