What it is:
Liquid biopsy screening is a new blood test that aims to detect and identify a wide range of cancers in their early stages. Current methods for detecting cancer rely on individual screenings for each type, such as an X-ray (mammogram) for breast cancer or a stool sample for colon cancer.
Screening aims to identify the disease as early as possible before symptoms occur. Still, the individual process means it relies on categorizing the most at-risk people, leading to only the “most” at-risk populations getting tested rather than preventing all the possible cancers from developing. Screenings tend to be performed in older adults (~60 years of age) and, therefore, result in later-stage cancer identifications. The recommendation factors for screening are based on medical history, age, gender, and other risk factors.
Recent research has led to liquid biopsy screening. Liquid biopsies mean you’re reviewing the blood for the cancer rather than looking at tissues. Normal screening takes a tissue sample and then reviews the cells to see if they’re cancerous. This requires abnormal sites to have already occurred or to only test high-risk populations. Liquid biopsies aim to detect the marker shared by many different types of cancer using a sample of a person’s blood.
Liquid biopsy cancer detection aims to offer a non-invasive, far-reaching, and accurate early detection method.
Purported claims:
The Galleri test claims:
Early Multi-Cancer Detection: Screening for over 50 types of cancer, many of which are not commonly screened for, from a single blood draw.
Signal Origin: Can identify the cancer signal's origin in the body.
Complement to Existing Screenings: By covering a range of cancers that don't necessarily have routine screenings, it aims to fill in the gaps left by current screening methods.
Convenient and Minimally Invasive: Requiring only a blood sample the test aims to be accessible with a low-barrier to entry.
What the science says:
Current cancer screening methods are typically limited to specific criteria dependent on age, gender, medical history, and certain risk factors. However, cancer is one of the leading causes of death worldwide, so although there are some measures in place, it is not enough.
Striving to catch cancers earlier and incorporating lifestyle factors that minimize the risk are just some ways to lessen the mortality rates.
New testing methods are always being developed and reviewed. Today, we are focusing on the specifics of Grail’s Galleri test, but other companies and tests in the market include:
Exact Sciences: Known for its Cologuard test for colorectal cancer, it is also developing multi-cancer detection tests.
Freenome: Focuses on early cancer detection through blood-based tests using AI and machine learning.
Guardant Health: Offers the Guardant360 test for cancer detection and monitoring, and is working on broader cancer screening tests.
Speak to your personal doctor if you wish to know more about your cancer screening options.
Currently, the Galleri test has not been approved by the FDA as it is experimental. However, it does have a breakthrough device designation which is intended to expedite the development and review of technologies that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This allows the test to be available as a Laboratory Developed Test (LDT) under the Clinical Laboratory Improvement Amendments (CLIA).
It is also in a combined research trial with the British National Health Service (NHS) to see if the test, alongside current screening methods, can identify cancers earlier.
Galleri aims to address the need for an early detection method for multiple cancers, especially those that lack routine screening tests. It aims to fill the gap left by existing screenings by utilizing a simple, single blood draw. Currently, its main goals are:
Early Detection: Identifying cancers at an earlier stage when they are more treatable.
Broad Coverage: Aiming to detect over 50 types of cancer, many of which are not covered by current screening methods.
Non-Invasive: Using a single blood draw, it brings down the barrier of many traditional screenings.
Galleri's unique advantage is its ability to detect specific patterns in DNA fragments shed by cancer cells into the bloodstream. Using machine learning algorithms, Grail analyzes vast amounts of genetic data and compares it to a large database of known cancer and normal tissue patterns. By detecting these markers early, it allows for further screening, such as MRI or PET scans in the site of predicted origin.
Therefore, the more people they screen, the more accurate the data recognition becomes, and the more cancers can be identified.
While Galleri's method is a significant advancement, it's important to note that certain cancers, such as brain or slow-growing cells, may still be difficult to identify because these cancers don't shed much DNA into the bloodstream. Therefore, remaining vigilant in current screening methods, being attuned to possible symptoms, and implementing positive lifestyle factors are crucial in mitigating risk.
The most significant downside risk to be aware of is the possibility of a "false positive" result, meaning that the test indicated a potential cancer signal, but further testing did not detect cancer. When a liquid biopsy detects a possible cancer signal, it's essential to discuss this carefully with your primary doctor. Additional testing could be needed, such as advanced imaging or a tissue biopsy.
If cancer is detected, the treatment options are still similar, along the lines of surgery, immunotherapy, chemotherapy, and radiation. However, knowing the location of the cancer and catching it at an earlier stage allows for changes to be implemented early, potentially leading to a higher survival rate.
Our take:
Detecting cancer early and implementing lifestyle changes can help mitigate your risk. Early cancer screening methods like the Galleri test are exciting new resources to add to doctors’ toolkits. However, ensuring a test is performed under the supervision of your personal doctor, and preferably also a specialist within the cancer realm may help prevent issues that come with this new screening test.
As the test is in its infancy, issues such as a positive result, where further screening is unable to identify the possible cancer, may cause extreme distress and, therefore, should not be performed lightly. Grail’s Galleri test does aim for high specificity (promising a low false-positive rate), but ensure you have the proper medical support in place.
Whether you decide to opt for a Galleri test or not, Apeiron Life experts can assist you in curbing your cancer risk. Behaviors such as poor diet, physical inactivity, alcohol use, tobacco use, and exposure to harmful substances increase the risk of developing cancer. This also means incorporating as many healthful habits as possible can decrease your risk and may limit the harmful effects if cancer occurs. Speak to your Client Advocate to discuss lifestyle changes to reduce your risk of cancer.
Will this benefit you?
Yes, but having suitable medical supervision is crucial. And recognizing the possible psychological and emotional health consequences.
Still curious to try it? If you do, here’s what to keep an eye on:
If you are interested in these tests speak to your personal doctor about access to the Grail Galeri test. Once you have performed the test speak to your Client Advocate on how we can assist your medical journey and the wellness and lifestyle changes that occur alongside it.
Tests are not perfect and may find abnormal changes that aren’t there (false positive) or detect results that may not develop into cancer. This can cause undue stress and anxiety; therefore, being skeptical and following up with other testing methods is vital.
There is also a risk of a false negative. Therefore, it is important to see the Galleri test as an addition to the usual recommended cancer screenings rather than a replacement.
References and additional reading:
https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests
https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
https://www.cancer.org/cancer/screening/multi-cancer-early-detection-tests.html
https://www.cancerresearchuk.org/about-cancer/tests-and-scans/blood-tests/galleri-blood-test
https://www.nhs.uk/conditions/predictive-genetic-tests-cancer/
https://www.annalsofoncology.org/article/S0923-7534(21)02046-9/fulltext
https://www.nihr.ac.uk/news/new-blood-test-finds-two-thirds-of-cancers/33681
https://www.cancer.gov/about-cancer/causes-prevention/genetics/genetic-testing-fact-sheet
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