Galleri Multi-Cancer Early Detection Test Rx
Screen for a signal shared by 50+ cancer types–often before symptoms appear–with one simple blood draw, giving you more opportunity to find something earlier and take action.
- One-time charge
- Quest Diagnostics lab visit and blood draw
- Results in about two weeks
- HSA / FSA
Frequently asked questions
Galleri looks at a single blood draw for cell-free DNA fragments carrying methylation patterns associated with cancer, patterns that can show up before other symptoms do.3 It’s designed to screen for a signal shared across more than 50 types of cancer at once. When a signal is present, the test can also help predict where in the body it’s likely coming from, which helps guide what your provider does next.1
Accuracy varies by cancer type and stage. In GRAIL’s PATHFINDER 2 study, Galleri detected a signal in about 74% of the twelve cancers responsible for most cancer deaths, and around 40% across all cancer types studied together. Specificity was high, over 99%, meaning a signal detected result is rarely a false alarm.1
And when Galleri does detect something, related research found the majority of those cancers were caught at an early, more treatable stage, with another study showing meaningful reduction in late-stage (Stage 4) diagnoses.2 Still, no test like this catches everything, which is exactly why it’s designed to work alongside your other screenings rather than in place of them.
<span style=”font-weight: 400;”>No, Galleri has not been cleared or approved by the FDA. It’s offered as a laboratory-developed test, which operates under a different regulatory framework (CLIA) than an FDA-approved drug or device. GRAIL has submitted PATHFINDER 2 data to the FDA as part of a formal approval application </span><span style=”font-weight: 400;”>expected to complete in 2026</span><span style=”font-weight: 400;”>, so the regulatory picture is actively evolving, but as of now, no FDA clearance exists.<sup>1</sup></span>
If approved, your collection kit will be mailed to you. Schedule your blood draw at a participating Quest Diagnostics location and bring the complete kit with you. Results are generally available about two weeks after your sample reaches the GRAIL laboratory.
If prescribed, a US-licensed medical provider will provide specific instructions with your care plan.
Important safety information and common side effects
The test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider.
The test is intended to detect cancer signals and predict where in the body the cancer signal is located. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “Cancer Signal Not Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g. imaging) to confirm cancer.
If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur.
This test is available by prescription only. Additionally, the information above is only a summary and may not contain all important safety information. To learn more, please visit Galleri’s safety information page.
Note: The above statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
Disclaimer
What is the Galleri Multi-Cancer Early Detection Test?
Most cancer deaths come from cancers that don’t have a recommended screening test.4
Galleri uses one blood draw to screen for a signal shared by 50+ cancer types—giving you an opportunity to find something earlier and act sooner.1
5-year cancer-specific survival when cancer is diagnosed before it spreads5
How Galleri Multi-Cancer Early Detection works
Cancer leaves clues
Galleri finds patterns
Origin is predicted
Chances improve
Results that can change what comes next
- 0
- cancer types screened with one simple blood draw¹
- 0
- new Galleri detected cancers caught at an early stage (Stage I-III)²
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- cancer deaths that come from cancers without recommended screening⁷
We’re leading the way in preventive care
Clinically studied
The science of Galleri Multi-Cancer Early Detection Test
Every cell releases small fragments of DNA into the bloodstream. What makes Galleri interesting is that it does not simply count those fragments. It studies the chemical patterns attached to them, called methylation.3
Methylation helps regulate how cells behave, and cancer can change them in recognizable ways. Galleri uses machine learning to distinguish patterns commonly associated with cancer.1 3 If Galleri detects a signal, it predicts one of 18 possible Cancer Signal Origins—the tissue or organ where that signal is most likely coming from—with roughly 88% accuracy in published research.6 9
Choosing how you age starts here
Connect with a clinician
Visit a lab location
Receive your results
Disclaimer
Advanced testing, personalized.
Frequently asked questions
Galleri is generally recommended for adults with an elevated risk of cancer, most often those 50 and older, since cancer risk rises with age.10 It requires a prescription, so your provider reviews your health history during an online evaluation to help determine whether it’s an appropriate fit for your specific situation before moving forward.
After your online evaluation, if you’re approved, you’ll get a blood draw kit and schedule your draw at a nearby lab. Your sample goes to GRAIL’s lab for analysis, and results typically land in your AgelessRx portal, along with an email notification, about two weeks after your sample arrives.
A “signal detected” result isn’t a cancer diagnosis, it means the test found a pattern worth investigating further. Galleri’s ability to predict where a signal likely originated helps that follow-up start in a more targeted place rather than from scratch.
No. Galleri is designed to work in addition to the screenings you already do—mammograms, colonoscopies, Pap smears, and others—not instead of them. It doesn’t detect every cancer, and it isn’t a substitute for the screening schedule your provider already recommends based on your age and personal risk factors.