Labs and Advanced Testing
Galleri Multi-Cancer Early Detection Test
Galleri, from GRAIL, is a blood test that looks for a signal shared by many types of cancer and, if one is found, predicts where in the body it may come from. Your provider will discuss whether it fits your situation. Galleri is not FDA-approved. It does not detect all cancers, can give false positive or false negative results, and does not replace recommended cancer screenings.
Important things to know
- Galleri is a laboratory-developed test. It has not been cleared or approved by the FDA.
- It does not detect all cancers, and it is not intended for people with symptoms of cancer.
- It can give false-positive results (a signal when no cancer is present) and false-negative results (no signal when cancer is present).
- A “cancer signal detected” result is not a diagnosis. It requires diagnostic follow-up, such as imaging or other tests, which your provider will help arrange.
- Galleri is meant to be used in addition to, not instead of, the cancer screenings your provider recommends, such as mammography, colonoscopy, cervical or lung screening.
Learn more from the manufacturer
GRAIL publishes test information and performance data at galleri.com. This link goes to GRAIL’s website; NCFM is not responsible for its content. NCFM is not affiliated with GRAIL. We don’t restate performance numbers here; your provider can walk through them with you.
Cost
Insurance coverage for Galleri is limited. Ask us about cost before testing.
Therapies are offered after provider evaluation. Suitability and individual results vary. This information is educational and is not a substitute for advice from your physician.
About the test
Images from GRAIL, the maker of Galleri.
Sample results
Galleri reports one of two results. Example format only.
Result
Cancer Signal Not Detected
A cancer signal was not detected in this example sample. This does not rule out cancer, and recommended screenings should continue.
Example data · not a real patient
Result
Cancer Signal Detected
Cancer Signal Origin (example): [Example origin]. A detected signal is not a diagnosis; follow-up testing is needed to confirm whether cancer is present.
Example data · not a real patient
Not a real patient. Values are made up for illustration. Ranges vary by lab. Not medical advice and makes no treatment recommendations.
See how GRAIL explains Galleri results (opens the vendor’s site)
Galleri at a glance
Galleri is a multi-cancer early detection blood test from GRAIL. It is available by prescription only.
What it measures
It looks for DNA fragments that cancers can shed into the blood. If it finds a cancer signal, it predicts the tissue or organ where the signal may come from.
Who it may be for
GRAIL recommends it for adults with an elevated risk of cancer, such as people age 50 or older. It is not recommended during pregnancy, for people 21 or younger, or during active cancer treatment.
How the sample is collected
A standard blood draw.
Home or office
The blood is drawn in our office or at a draw site, then sent to the GRAIL lab.
Turnaround
GRAIL says results are usually ready about two weeks after the lab receives the sample.
What the report includes
One of two results: No Cancer Signal Detected, or Cancer Signal Detected. A detected result includes the predicted signal origin.
Review with your provider
Your provider reviews the result with you. A detected signal needs follow-up diagnostic testing, such as imaging, to confirm or rule out cancer.
Important limitations
Galleri does not detect a signal for all cancers. False positive and false negative results can occur. It does not replace the cancer screenings your provider recommends. A No Cancer Signal Detected result does not rule out cancer.
Sources: galleri.com
How it works
Evaluation
Each test is ordered individually by your provider after an evaluation.
Testing
Your provider explains what the test can and cannot show before ordering it.
Review
Results are interpreted by your provider alongside your history.
Frequently asked questions
Who orders my tests?
Each test is ordered individually by your provider after an evaluation.
Who explains my results?
Results are interpreted by your provider alongside your history.
Is NCFM affiliated with the laboratory?
No. NCFM is not affiliated with the laboratories it uses.
Does Galleri replace my mammogram, colonoscopy or other screenings?
No. GRAIL says Galleri should be used in addition to the cancer screenings your provider recommends, not instead of them.
Can Galleri miss a cancer?
Yes. Galleri does not detect a signal for all cancers, and false negative results can occur. A No Cancer Signal Detected result does not rule out cancer.
What happens if a cancer signal is detected?
Your provider will arrange diagnostic follow-up, such as imaging, to confirm or rule out cancer. A detected signal is not a diagnosis, and false positives can occur.
Is Galleri FDA approved?
No. GRAIL states that Galleri has not been cleared or approved by the FDA. It is run in a CLIA-certified, CAP-accredited lab.
Is Galleri covered by insurance?
GRAIL says most health insurance plans do not cover Galleri. Our team can explain your options before you order.
Start with a conversation.
Call (239) 649-7400, or (239) 434-9699 for Hyperbaric.