Are Cancer Blood Tests Worth It? (Bloomberg)

Galleri, from a company called Grail, is just one of a number of new tests seeking to detect multiple cancers very early on. It’s probably the buzziest of this new class — in part because it’s the most widely available and also because it’s at the center of a cross-Atlantic antitrust battle that started when DNA-sequencing giant Illumina moved to acquire Grail in 2021.

The promise of such tests is great: Patient survival rates are much higher when cancers are detected early.

“Someday this will become routine for people who are at high risk,” Eric Topol, director of Scripps Research Translational Institute, tells me. “But we’re not there yet*.”*

The Grail test is already commercially available. But all of these tests will require more study to show what they do best, who’s most likely to benefit and how good they are at actually preventing deaths. The UK’s National Health Service is partnering with Grail to evaluate just such questions.

Another thing that will become clearer with more time and data, says Topol, is the best approach for detecting the signals of early-stage cancer and then figuring out where it is in the body. Grail and its competitors, like Thrive (Thrive was acquired by Exact Sciences in 2020), have taken pretty drastically different approaches to doing this. The best test, Topol tells me, might actually be one that combines several different approaches.

Full writeup here: https://archive.ph/H1TPc

Links to the two Cancer Screening Companies:

Exact Sciences

https://www.exactsciences.com

Galleri

Related Reading:

Exact Sciences says its new colon cancer test shows 30% lower false positive rate

https://www.reuters.com/business/healthcare-pharmaceuticals/exact-sciences-says-its-new-colon-cancer-test-shows-30-lower-false-positive-rate-2023-06-20/

Multi-cancer early detection test in symptomatic patients referred for cancer investigation in England and Wales (SYMPLIFY): a large-scale, observational cohort study

Interpretation

This first large-scale prospective evaluation of an MCED diagnostic test in a symptomatic population demonstrates the feasibility of using an MCED test to assist clinicians with decisions regarding urgency and route of referral from primary care. Our data provide the basis for a prospective, interventional study in patients presenting to primary care with non-specific signs and symptoms.

Open Access/Full Paper:
https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00277-2/fulltext

and in the “oops” department:

Roughly 400 patients who agreed to take cancer detection tests with biotech firm Grail received letters indicating they may have cancer, but the company said the letters were not accurate, blaming it on a “software configuration issue” that caused its telemedicine vendor to send out the incorrect information—a development that’s caused at least one life insurance company to reevaluate its business with the cancer screening firm, according to the Financial Times.

What to Know Now: Commercial blood tests are one tool to help detect pancreatic cancer at an earlier stage. These tests detect certain markers or compounds in the blood that may suggest cancer is present. Several now on the market are multi-cancer tests, like the Galleri test from GRAIL and OneTest™, a multi-cancer test from 20/20 GeneSystems that looks for certain proteins that may signal the presence of cancer.

The Avantect Pancreatic Cancer Test from ClearNote Health focuses specifically on pancreatic cancer. It uses a blood sample to detect a biomarker called “circulating free DNA.” A negative test result means that this biomarker has not been detected. A positive test result means that this biomarker was detected, which could mean a person has pancreatic cancer, or other conditions such as pancreatitis or intraductal papillary neoplasms (IPMNs, a type of cyst of the pancreas).

It’s important to note that a blood test cannot say with certainty whether a person has pancreatic cancer. Follow-up testing such as imaging and a biopsy are necessary. Since many blood tests are expensive and not always covered by insurance, the first step is to have a conversation with your doctor about your risk factors and whether a blood test would be helpful.

Also better on all detection fronts it seems. (and all this is from a 2x larger trial)

Wish they could up the game more materially on the pre-cancerous detection aspects though.

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This one is 70% cheaper than Grail.

Not sure how valuable it is, but they say:

$269.00

OneTest™ Premium is a multi-cancer early detection blood test which reports risk for eight of the most common cancer types. These eight cancers represent 92.8%* of all cancers diagnosed in the US, according to the American Cancer Society. These cancers include lung, liver, colon, stomach, pancreatic, prostate (for men), breast and ovarian (for women).

OneTest™ Premium includes 11 biomarkers including the cancer biomarkers in OneTest™ (AFP, CEA, CA 19-9, CA 125, CA 15-3, PSA, CYFRA 21-1) and five additional biomarkers which measure inflammation, an important biological response associated with some types of cancer. These are HE4, ApoA1, B2-Microglobulin, CRP, and Prealbumin.

[] Reference: American Cancer Society: Cancer Statistics, 2023”* in the American Cancer Society’s journal CA: A Cancer Journal for Clinicians.

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It’s certainly a dilemma to take the test or not. Detecting cancer early is of course good, but can you imagine the emotional stress let alone what kind of medical exams it would put you through to get a false positive? Sorry, I don’t have time today to read all of the citations but does a positive test indicate what kind of cancer you may have?

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Anyone know / see what this one costs?

In addition, the Centers for Medicare and Medicaid Services (CMS) announced that it has proposed preliminary reimbursement rate determinations for new and revised CPT codes issued by the AMA, including 0410U for the Avantect Pancreatic Cancer Detection Test. ClearNote Health is aligned with CMS on their reimbursement recommendation of $1,160.00 as this rate is similar to methods and procedures currently reimbursed on the existing Clinical Laboratory Fee Schedule. CMS is expected to issue a final determination on the rate for 0410U later this year. Final rates established by CMS for the clinical laboratory fee schedule will be effective on January 1, 2024.

Man, that is expensive for 1 single type of cancer test. Makes sene for someone with symptoms or at high risk or with other blood work pointing in the direction of this type of cancer being a risk, but does not make sense like a general screening along the lines of Grail, OneTest and/or ColoGuard…

… hope they come up with a lower out of pocket price in some way

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Yes - probably only justifiable if you have significant risk factors in this area…

Risk factors for pancreatic cancer include:

  • Older age: Pancreatic cancer usually develops after age 65.
  • Unhealthy diet: Eating a lot of red and processed meats and few vegetables puts you at greater risk.
  • Excess weight: Obesity increases your risk for developing pancreatic cancer.
  • Smoking: Heavy smoking may contribute to the development of pancreatic cancer.
  • Family history: If one or more of your family members have had pancreatic cancer, you may be at increased risk.
  • Pancreatic cysts: Noncancerous cysts carry a small risk of turning into aggressive pancreatic cancer.
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And they may be on a path to get even better at the early detection:

https://www.science.org/doi/10.1126/science.adn1886

And

https://www.science.org/doi/10.1126/science.adf2341

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The study by WHO scientists suggests the number of late-stage cancers, the endpoint in Grail’s trials of its cancer liquid biopsy, is insufficient to show the Galleri test benefits patients.

A new analysis published Sunday challenges the clinical trial endpoint the cancer screening firm Grail is using to evaluate its blood test aimed at simultaneously detecting multiple types of tumors early.

Cancer Stage Compared With Mortality as End Points in Randomized Clinical Trials of Cancer ScreeningA Systematic Review and Meta-Analysis

Key Points

Question Compared with the end point of cancer-specific mortality, is incidence of late-stage cancer a suitable alternative end point in randomized clinical trials of cancer screening?

Findings In this systematic review and meta-analysis that included 41 randomized clinical trials of cancer screening, correlation between the reduction in stage III and IV cancer and the reduction in cancer-specific mortality varied by cancer type. The correlation was high in trials that screened for ovarian (Pearson ρ = 0.99) and lung (Pearson ρ = 0.92) cancers, moderate for breast cancer (Pearson ρ = 0.70), and weak for colorectal (Pearson ρ = 0.39) and prostate (Pearson ρ = −0.69) cancers.

Meaning In randomized clinical trials of cancer screening, the correlation between reductions in late-stage cancer and cancer-specific mortality varied meaningfully by cancer type. The end point of late-stage cancer may be an appropriate alternative to cancer-specific mortality for randomized clinical trials of screening for some types of cancer, but not for others.

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Thanks for sharing. Haven’t read, but might be valuable for us all to take into account that the WHO is often extremely slow to change, often backward looking and does not want to annoy any of its member states so often thing they say ends up being watered down all the way to the minimum acceptable view to reach a consensus…

For a counter perspective that might be valuable to review side by side with above from the WHO it might be valuable to listen to or read the transcript from these two podcasts

1. AMA 56: Cancer screening: pros and cons, screening options, interpreting results, and more

"There has been a pretty clear and consistent benefit [to cancer screening] that has been demonstrated, and the exceptions I think have a pretty clear sense of why.” —Peter Attia

See especially these parts

  • Inconsistencies between cancer screening trials regarding benefits to survival rates [25:45];
  • What are some of the reasons why clinical trials don’t always improve cancer-specific mortality? [30:15];
  • What are the arguments against population-level cancer screening? [42:00];
  • Cancer screening outside the recommended guidelines: risks and benefits, interpreting results, and other considerations [46:00];

And also

  • Cancer screening modalities: options for cancer screening both within standard recommendations and beyond [58:30];
  • The strengths and limitations of various types of cancer screening [1:02:15];

And also

#2. Episode 290 ‒ Liquid biopsies for early cancer detection, the role of epigenetics in aging, and the future of aging research | Alex Aravanis, M.D., Ph.D.

  • The development of a universal blood test for cancer detection, and a discussion of specificity of tests [46:00];
  • Advancements in cell-free DNA analysis and development of a multi-cancer screening test at GRAIL [51:00];

And

  • The performance of the GRAIL Galleri test and its ability to detect various types and stages of cancer [1:21:00];
  • Do early cancer detection methods, like liquid biopsies, translate to improvement in overall survival? [1:27:45];

For instance I think there total cholesterol recommendation is <190 mg/dL which is not what almost any expert would suggest for someone who want to maximize and optimize their longevity and long term healthspan…

Worldwide cancer data

Global cancer statistics for the most common cancers in the world.

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You can test your blood for 50 kids of cancer…but is that a good idea?

It takes a certain amount of confidence to call your biotech company Grail. According to its website, the Menlo Park–based firm got its name because its “co-founders believed a simple blood test could be the ‘holy GRAIL’ of cancer detection.” Now the company claims that its “first-of-its-kind” screening tool, called Galleri, “redefines what’s possible.” At the cost of a needle stick and $949, the company can check your blood for more than 50 forms of cancer all at once.

The Galleri test, as well as many others of its type that are in development, is meant to sniff out malignant DNA floating in a person’s veins, including bits of tumors that otherwise might not be identified until they’ve spread. But the rapid introduction of this new technology, which is now available through major U.S. health systems, isn’t really guaranteed to help patients. Indeed, a contentious debate about its potential benefits has been playing out in the scientific literature for the past few years. Multi-cancer-screening tools—or “cancer-finding supertests,” as Galleri has been called—aren’t yet endorsed by the U.S. Preventive Services Task Force, or formally approved by the Food and Drug Administration. For the moment, health-care providers can offer Galleri only through a commonly used regulatory loophole that the government is desperately trying to close. Being able to distribute the company’s “prescription-only, well-validated test” in advance of full FDA approval is a good thing, Kristen Davis, a Grail spokesperson told me, because it gives patients “timely access to an important tool in the detection of unscreened cancers and allows for important real-world evidence collection.” That’s one way to look at it. Here’s another: The rush to get Galleri and related products into doctors’ offices skips right over the most important step in clinical development: proving that they really work.

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My brother did it and they declared him cancer free. But you pay out of pocket and it’s over $800. I’d rather have upgrades to better things, like chainsaws, guns, even car parts. These things will make me so happy I won’t get cancer.

Blood proteins could indicate cancer seven years before diagnosis

Scientists have discovered proteins in the blood that could indicate that cancer is developing up to seven years before diagnosis.

Researchers in two studies funded by Cancer Research UK identified 618 proteins linked to 19 types of cancer — including 107 proteins in blood collected seven years before the disease was found.

The scientists, from Oxford Population Health, suggest that these proteins may be involved in the earlier stages of cancer and could be used to detect it much earlier.

The first paper, published on Wednesday in Nature Communications, used blood samples from the UK Biobank from more than 44,000 people — including 4,900 who later had a cancer diagnosis.

Using a technique called proteomics, the team studied nearly 1,500 proteins in each blood sample and analysed which were present in those who went on to get cancer. They found 107 proteins that were present seven years before an official diagnosis and 182 proteins present three years before diagnosis.

In the second study, published at the end of April in the same journal, scientists analysed genetic data from more than 300,000 cancer cases to understand which proteins could be linked to cancer development. > They found 40 blood proteins that were thought to influence someone’s risk of getting nine different types of cancer.

Joshua Atkins, senior genomic epidemiologist at Oxford Population Health and joint first author of the first study, said:“The genes we are born with, and the proteins made from them, are hugely influential in how cancer starts and grows. Thanks to the thousands of people who gave blood samples to UK BioBank, we are building a much more comprehensive picture of how genes influence cancer development over many years.”

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