If you’re over the age of 50 or have other risk factors for cancer, then you are probably getting regular screenings for various types of cancer. Maybe you’re already getting regularly checked for breast cancer, prostate cancer, or colon cancer.
However, some of the most deadly types of cancer are not detected in many regular pre-screenings. Many people find themselves concerned about their cancer risk without a comprehensive way to check for multiple forms of cancer at once.
The Galleri blood test for cancer is a recent invention that uses a small blood sample to test for more than fifty types of cancer. If it sounds revolutionary, that’s because it is; early cancer detection is a major game-changer in the world of cancer treatment and it is already saving lives. But if you’ve been recommended to take this test or if you are considering it as an option, then there is still a lot that you should know before trying it out.
Please note: this article is simply for educational purposes and should not act as a substitute for advice from a medical professional. Reach out to Craft Concierge for direct primary care in Tulsa or Tampa to get an opinion from a doctor.
Overview: How does the Galleri blood test work?
You might know that all DNA contains genes, but you might not know that not all of those genes are expressed. Think of DNA like a large switchboard: you have a selection of light switches, but some genes are “turned on,” and some are “turned off,” in large part due to a process called methylation. In this process, certain chemical groups block the proteins that “read” DNA sequences, thus changing the way the genes are expressed. DNA methylation can change how DNA acts without changing its sequence.
Your cells all have their own DNA as well. And while many cells may have the same DNA, the methylation pattern can be different on each one (think: different lights on the switchboard are on or off). Well, cancer cells and healthy cells have different methylation patterns. They also have different patterns depending on where they come from in the body.
When cells in your body die, they release fragments of DNA into your bloodstream (this is called “cell-free DNA”). The Galleri blood test uses a blood sample to collect the cell-free DNA in your blood, then it uses machine learning to notice methylation patterns on them that might be associated with cancer. It also identifies where the cell-free DNA comes from, which is why it can tell you what type of cancer you may have.
To summarize: The Galleri Multi-Cancer Blood Test looks at bits of DNA left by dead cells in your bloodstream and tests their patterns to see where they came from and whether or not they came from cancer cells. |
So, can a blood test detect cancer in the body? Not every typical blood test can, but the Galleri blood test can use highly specialized and modern methods to detect more than 50 types of cancer. The Galleri test is a type of MCED, Multi-Cancer Early Detection method that uses just one blood sample to test for multiple types of cancer. However, once a certain type of cancer is detected, then further tests will be necessary to confirm and fully understand the results.
Galleri Blood Test: Which cancers does it check for?
Here is a comprehensive list of the cancer types that the Galleri cancer test is capable of detecting. Please note that false positives and false negatives can happen, and we will go into more depth on the accuracy of this test later on.
Cancers of the Digestive System (including liver, gallbladder, and pancreatic):
- Ampulla of Vater
- Small Intestine
- Gastrointestinal Stromal Tumor
- Stomach
- Colon and Rectum
- Neuroendocrine Tumors of the Colon and Rectum
- Anus
- Bile Ducts, Perihilar
- Liver
- Bile Ducts, Distal
- Gallbladder
- Bile Ducts, Intrahepatic
- Esophagus and Esophagogastric Junction
- Cancer of/ from the appendix
- Neuroendocrine Tumors of the Appendix
- Pancreas, exocrine
- Neuroendocrine Tumors of the Pancreas
Cancers of the Respiratory System:
- Larynx
- Lung
- Mesothelioma, Malignant Pleural
- Oropharynx (HPV-Mediated, p16+)
- Oral Cavity
- Nasal Cavity and Paranasal Sinuses Nasopharynx
- Oropharynx (p16-) and Hypopharynx
Cancers Affecting Only Women:
- Breast
- Cervix
- Gestational Trophoblastic Neoplasms
- Uterus, Sarcoma
- Ovary, Fallopian Tube and Primary Peritoneum
- Vagina
- Vulva
- Uterus, Carcinoma and Carcinosarcoma
Cancers Affecting Only Men:
- Penis
- Prostate
- Testis
Soft Tissue Sarcoma:
- Abdomen and Thoracic Visceral Organs
- Head and Neck
- Retroperitoneum
- Trunk and Extremities
- Unusual Histologies and Sites
Cancers of the Urinary System:
- Bladder, Urinary
- Adrenal Cortical Carcinoma
- Kidney
- Ureter, Renal Pelvis
Cancers of the Skeletal System:
- Bone cancer
- Leukemia
Cancers of the Immune System:
- Lymphoma (Hodgkin and Non-Hodgkin)
- Plasma Cell Myeloma and Plasma Cell Disorders
Integumentary System Cancers:
- Melanoma of the Skin
- Merkel Cell Carcinoma
Is the Galleri blood test FDA approved?
While this MCED blood test for cancer markers has been sold in the United States since 2021, it is not currently FDA-approved.
The FDA approval process is very involved, and it can take years. For that reason, the FDA has the Investigational Device Exemption (IDE). This exemption allows the FDA to start carrying out clinical studies on a product or device so that they can test its effectiveness and safety and get it on the road to premarketing FDA authorization.
Premarketing FDA authorization is the most intense approval process that the FDA has for medical devices. Achieving premarketing authorization from the FDA could mean that Medicare might start to cover the Galleri cancer test, making it available to those covered by the largest health insurance provider in the U.S. That would be an enormous step for Galleri (and their owners, GRAIL), especially considering that right now, the test is not covered by most insurers.
This most recent Galleri blood test trial is being carried out on more than 50,000 Medicare participants who can benefit from early cancer detection. The data that comes out of these tests will add to evidence from two other major studies that also received investigational device exemptions: the NHS Galleri trial, which is testing more than 140,000 volunteers in the U.K., and the Pathfinder 2 Study, which is currently seeking participants aged 50 years or older in North America.
The Galleri Blood Test Accuracy
A 2021 study used the Galleri blood test to test people who already knew they had cancer and people without cancer to see if the results would be accurate.
According to that study, the Galleri test, overall, caught 51.5% of instances of cancer. That means that a little less than half of the participants with cancer got a false negative result.
While that may sound low, consider that there are many types of cancer that are not even detectable until they show symptoms, and for some, if they are showing symptoms, then it is already too late.
For example, part of what makes pancreatic cancer so deadly is that only 10% of pancreatic cancers are detected while the cancer is still contained in the pancreas; the other 90% are found when the cancer has already spread, which significantly lessens the chances of survival. A test that can detect these hard-to-find cancers early on could save lives.
This study also showed a few other interesting results. First, it is very rare that the Galleri test gives false positive results. It is also very accurate (88.7%) with detecting where the cancer comes from, meaning that it can point out to doctors precisely where they should continue carrying out tests to either confirm or deny the results of the Galleri test.
Cost: Is the Galleri Blood Test Worth it?
The Galleri blood test typically costs around $950, depending on where you get it. It is not covered by Medicare. In fact, it is not covered by most insurance providers.
That said, you might have a few options for paying for it.
- If you have an FSA or HSA, you might be able to use pre-tax dollars to pay for the test.
- There are more and more trials every day for the test, and they are looking for participants.
- Some direct primary care practices offer the Galleri blood test as part of their plans. For example, if you are paying a monthly fee as part of the Comprehensive Program with us at Craft Concierge, similarly to how you would pay your insurance company, then you can have this state-of-the-art cancer detection blood test as a part of your program. In fact, our Comprehensive Program includes a specific Early Cancer Detection strategy that uses the Galleri test as part of a cohesive protocol designed to detect signs of cancer very early on.
So, is the Galleri Blood Test worth it? We believe it is, especially if you are over the age of 50 or otherwise have a predisposition to cancer.
We chose to include it as part of our direct primary care services because we see it as a major advancement in cancer detection technology, and we recognize the immense value of early detection. The earlier you catch cancer, the easier it is to treat, so any test (especially a non-invasive test like a small blood sample) that can notice cancer early on is a wise investment in our book. Plus, the Galleri test looks at so many different types of cancer for just one fee, whereas testing for most of those types of cancer (including very rare ones) individually would be impossible, time-consuming, or incredibly cost-prohibitive.
That said, we recommend speaking with a doctor about your options. A health professional can look at your family history, current lifestyle, and other determining factors to let you know if a Galleri test would be worth it in your specific case.
Galleri Blood Test through Direct Primary Care Oklahoma and Florida
At Craft Concierge, we offer direct primary care at our two locations in Tulsa and Tampa. Direct primary care offers an alternative to traditional healthcare with insurance. With direct primary care, instead of paying a monthly fee to an insurance provider and dealing with copays, deductibles, and claims, you pay a monthly fee directly to your doctor’s office, and they take care of you based on your needs.
Many people prefer this model because it allows them to build relationships and trust with their doctor. They also can invest in a plan that is specific to their needs (such as a cardiovascular program or an early cancer detection program). Many people actually end up saving money with a direct primary care model while also taking close care of their health.
At Craft Concierge, we invest in cutting-edge medical equipment so that our patients receive the most premium care that they possibly can.
The Galleri Blood Test is a great example of the benefits of direct primary care. The Galleri test would cost almost $1,000 out of pocket if you have insurance (on top of what you are already paying monthly for insurance). But if you have a direct primary care plan with Craft Concierge, you would have that test, and more, included in your program. Because of our position as a direct primary care provider, we are able to be early adopters with technology like Galleri and give our patients personalized care like none other.
For direct primary care or a Galleri blood test in Tulsa or Tampa, contact us at Craft Concierge and ask us about our Early Cancer Detection program.
