Galleri^® Multi-Cancer Early Detection Screening Test

Galleri^® is a multi-cancer early detection test that can help find cancer early. This simple blood test screens for many cancers before you have symptoms.

While your doctor can offer screenings today for five specific cancers, nearly 70% of cancer deaths are caused by cancers that do not have recommended screenings available.

In general, when cancer is found early, there are more treatment options and a better chance of a positive outcome.

It is important to continue having routine cancer screenings that are right for your age, personal and family medical history and risk factors as directed by your doctor. The Galleri blood test does not replace routine cancer screenings (such as breast, cervical, colorectal, lung and prostate). It can be used in addition to these screenings.

Galleri will not diagnose cancer and is not a genetic risk assessment. It looks for DNA fragments that act like unique fingerprints of cancer. Because the Galleri test looks for active cancer, it will not predict your future risk of developing cancer.

Who Can Take the Galleri Test

If you are interested in the Galleri test, talk with your Froedtert & MCW doctor to discuss the test’s risks and benefits.

Galleri is available to patients who have a doctor within the Froedtert & the Medical College of Wisconsin health network. A doctor may recommend it for people who have a higher risk of developing cancer, such as people ages 50 or older. People ages 21 or younger, pregnant women or people currently having cancer treatment should not take the Galleri test.

The test requires a doctor’s order for a blood draw. With your doctor’s order, you can have the test at most Froedtert & MCW labs and Wisconsin Diagnostic Laboratories. No fasting is needed.

Cost

Insurance companies do not cover the cost of the Galleri test. Froedtert & MCW patients can take the test for an out-of-pocket fee of $789. GRAIL will bill you directly for this test. The Froedtert & MCW lab where you get your blood drawn may bill you $30.

If your Galleri test results show you may have cancer, your doctor will order more tests like imaging scans, blood tests or tissue biopsies to confirm or rule out cancer. The fee you pay for the Galleri test does not cover the costs of any diagnostic tests or cancer treatment.

Your Galleri Test Results

Your doctor will receive your test results about two weeks after your blood sample arrives at the lab. You will receive a communication about your results and any recommended next steps, as needed.

Results that say cancer signal detected mean cancer could be present. The results will also predict the most likely origin of the cancer in your body. If Galleri results predict you may have cancer, your doctor will recommend more tests to confirm or rule out a cancer diagnosis. If additional tests confirm you have cancer, your doctor will refer you to the appropriate cancer treatment team.

If results say no cancer signal detected, it is unlikely that you have cancer. Galleri does not detect signals for all cancers, and it is not possible to detect all cancers in the blood. False positive results and false negative results occur. Talk with your doctor to learn more.

How Does the Galleri Test Work?

Cancers growing in the body shed fragments of DNA into the bloodstream. Although there are many types of cancer, the DNA fragments act like a unique “fingerprint” of cancer. With this information, the Galleri test provides direction to your doctor about the cancer’s origin and helps guide next steps to diagnose or rule out cancer. Since Galleri detects DNA shed into the blood by cancers that are developing, the more aggressive the cancer, the stronger the signal will be and the more likely it is to show up.

How Often Should I Take the Galleri Test

You may take the test as often as annually. It is recommended that you and your doctor discuss repeating the test and how often based on your risk factors for cancer. Cancer risk factors can include your age, your family and personal history of cancer, any known genetic mutations and lifestyle factors such as weight, nutrition, exercise habits and alcohol intake.

Important Galleri Safety Information and Lab Test Information

Read important safety and lab test information about the Galleri test.

Galleri^® is a registered trademark of GRAIL, LLC. The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those ages 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a health care provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger or undergoing active cancer treatment.

Results should be interpreted by a health care provider in the context of medical history, clinical signs and symptoms. A test result of “No Cancer Signal 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.

Rx only.

Laboratory/Test Information
GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined, by GRAIL. The Galleri test has not been cleared or approved by the Food and Drug Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.