A New Way to Screen for More Cancers

Go further with Galleri®. Adding the Galleri multi-cancer early detection test to your cancer screenings allows you to go beyond what's currently possible. Now you can screen for a signal shared by more than 50 types of cancer with Galleri.1

It's now available to eligible patients at Summit Medical Group.


What is the Galleri Test?

Through a simple blood draw, the Galleri multi-cancer early detection test detects a cancer signal shared by more than 50 types of cancer, many of which are not commonly screened for today. The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood.

The Galleri test is intended to be used in addition to — and not to replace — other cancer screening tests your healthcare provider recommends.

Key Benefits of the Galleri Test

Early cancer detection

Looks for a signal present in the blood that may indicate cancer, to allow for earlier treatment.1

Testing with ease

Completed with a simple blood draw.

Actionable results

  • If a cancer signal is found, the results predict where in the body the cancer may be located to help your healthcare provider guide your next steps.
  • Through a blood draw, the Galleri test looks for active cancer and does not predict your future genetic risk for cancer.
  • Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer.
  • The Galleri test does not detect a signal shared by all cancers and not all cancers can be detected in the blood. False positive and false negative results do occur. Galleri should be used in addition to screening tests your healthcare provider recommends.
a person holding a tube of medicine.

Getting Tested

The Galleri test can be included in a routine visit with your healthcare provider through a simple blood draw. Talk to your Summit Medical Group provider today about your risk for cancer, and whether the Galleri test is right for you.

The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. It is intended to be used in addition to — and not replace — other cancer screening tests your healthcare provider recommends. Not all cancers can be detected by the Galleri test. Your healthcare provider will discuss appropriate follow-up testing to confirm if cancer is present.

The testing process is comprised of three main steps:

  1. Make an appointment at Summit Medical Group to request the Galleri test
  2. Consult and blood draw
  3. Receive your test results

A more detailed explanation of each step is listed below:

1. Make An Appointment at Summit Medical Group to Request the Galleri Test

  1. To request a Galleri test, please call your doctor's office and schedule an appointment.
  2. Your doctor's office will confirm your eligibility before they make your appointment.

2. Consult and Blood Draw

  1. During your consult, the test request and medical history will be reviewed by your Summit provider. They will provide pre-test counseling to explain what the test may tell you.
  2. If your provider approves your test request, the doctor's office will complete your blood draw during your visit.

3. Receive Your Test Result

The ordering provider will reach out when your results are ready (about 2 weeks after your blood draw) and will share your result with you and coordinate any follow-up care if needed.

There are two (2) possible test results:

  1. No Cancer Signal Detected: No cancer signal was found. However, not all cancers can be detected by the Galleri test. Patients should continue with all routine screening tests that your Summit doctor recommends. Missing routine cancer screenings or ignoring symptoms could lead to a delayed diagnosis of cancer.
  2. Cancer Signal Detected: This means there is a suspicion of cancer. The Galleri test also predicts where in the body the cancer signal is coming from, but does not diagnose cancer. Your Summit doctor will discuss appropriate follow-up testing to confirm if cancer is present.

False-positive test results do occur. This means that the test reported a cancer signal, but cancer was not found after additional testing. False-negative test results also occur. This means that the test did not detect a cancer signal, but cancer was confirmed to be present after additional testing.

Galleri cannot predict your risk of developing cancer in the future. You should continue to take other cancer screening tests your healthcare provider recommends.

Still wondering what to expect from your result? Learn more about test results



FAQs

Who is eligible for the Galleri test?

Summit Medical Group is collaborating with GRAIL to provide access to the Galleri test to eligible patients. Eligibility requirements include: U.S. residency Age 50 years or older Not currently pregnant Not currently...

Summit Medical Group is collaborating with GRAIL to provide access to the Galleri test to eligible patients. Eligibility requirements include:

  • U.S. residency
  • Age 50 years or older
  • Not currently pregnant
  • Not currently undergoing active cancer treatment

Is a person with history of cancer eligible?

Yes, as long as you are not currently in active cancer treatment and have completed cancer treatment at least 5 years ago*. * excludes basal or squamous cell carcinoma of the skin

Yes, as long as you are not currently in active cancer treatment and have completed cancer treatment at least 5 years ago*.

* excludes basal or squamous cell carcinoma of the skin

Who confirms my eligibility and orders the Galleri test for me?

Your Summit doctor will review your test request and clinical eligibility, and will also approve your request and order the test if appropriate.

Is there a cost for me to participate?

The Summit Medical Group price for the Galleri test is $789 and is not covered by insurance. However, you may be able to use pre-tax dollars in your flexible spending account (FSA) or health savings account (HSA) to pay for the Galleri...

The Summit Medical Group price for the Galleri test is $789 and is not covered by insurance. However, you may be able to use pre-tax dollars in your flexible spending account (FSA) or health savings account (HSA) to pay for the Galleri test.

How does the Galleri test detect cancer in the blood?

The Galleri test looks for a signal present in the blood that may be associated with cancer at the time of your blood draw. If a cancer signal is detected, the results can point to where in the body...

The Galleri test looks for a signal present in the blood that may be associated with cancer at the time of your blood draw. If a cancer signal is detected, the results can point to where in the body the cancer signal is coming from to help your healthcare provider guide next steps. The Galleri test is recommended to be used along with other cancer screening tests such as colonoscopy or mammogram.

I am not at risk for cancer, nor do I have family history. Is the Galleri test really for me?

Family history is one of many risk factors associated with cancer development. Other risk factors include age, eating habits, lifestyle, living or working environments, genetics, and many others**....

Family history is one of many risk factors associated with cancer development. Other risk factors include age, eating habits, lifestyle, living or working environments, genetics, and many others**.

** https://training.seer.cancer.gov/disease/cancer/risk.html

What cancers does the Galleri test screen for?

In a clinical validation study (CCGA3*), the Galleri test detected a cancer signal shared by more than 50 types of cancer across all...

In a clinical validation study (CCGA3*), the Galleri test detected a cancer signal shared by more than 50 types of cancer across all stages.

*Circulating Cell-Free Genome Atlas (CCGA) sub-study

Why is the Galleri test recommended to be used along with other cancer screening tests?

The Galleri test detects a cancer signal shared by more than 50 types of cancers, however not all cancers can be detected in the blood. Recommended routine cancer screening tests such as colonoscopy or mammogram have been shown to...

The Galleri test detects a cancer signal shared by more than 50 types of cancers, however not all cancers can be detected in the blood. Recommended routine cancer screening tests such as colonoscopy or mammogram have been shown to reduce cancer deaths.

The Galleri test is intended to be used in addition to and not to replace these tests and can help maximize the chances of early cancer detection. Missing recommended screening or ignoring symptoms could lead to a delayed diagnosis of cancer.

Do I need to fast prior to the blood draw?

No preparation or fasting is required.

How much blood is needed for the Galleri test?

The test uses approximately 1.5 tablespoons (or about 20 mL) of blood in two tubes, typically from a vein in your arm.

How long does it take to return my Galleri test results?

Your sample will arrive at the lab one to two business days after your blood draw. Your results should be available to the ordering provider who ordered your test within 10 business days (Monday — Friday, excluding...

Your sample will arrive at the lab one to two business days after your blood draw. Your results should be available to the ordering provider who ordered your test within 10 business days (Monday — Friday, excluding holidays) from the time your sample is received at GRAIL.

You will receive your results about two weeks after your blood draw from the ordering provider.

What does it mean if I receive a “No Cancer Signal Detected” result?

This means that no cancer signal was found in your blood test. However, not all cancers can be detected by the Galleri test. Continue with all routine screening tests that your healthcare provider...

This means that no cancer signal was found in your blood test. However, not all cancers can be detected by the Galleri test. Continue with all routine screening tests that your healthcare provider recommends. Missing routine screenings or ignoring symptoms can lead to a delayed diagnosis of cancer.

What does it mean if I receive a “Cancer Signal Detected” result?

This means that there is a suspicion of cancer and additional tests are needed to see if you have cancer. Your doctor will share next steps as appropriate. The Galleri test can point to where in...

This means that there is a suspicion of cancer and additional tests are needed to see if you have cancer. Your doctor will share next steps as appropriate.

The Galleri test can point to where in the body the cancer is coming from to help your primary healthcare provider guide next steps. Your doctor will coordinate to order appropriate follow-up testing to confirm if cancer is present.

Why are additional tests needed when the Galleri test detects a cancer signal?

Galleri is a screening test that detects a cancer signal in blood. When a signal is detected, the Galleri test also predicts where in the body the signal is coming from. The Galleri test is not a diagnostic test. Additional tests,...

Galleri is a screening test that detects a cancer signal in blood. When a signal is detected, the Galleri test also predicts where in the body the signal is coming from. The Galleri test is not a diagnostic test. Additional tests, which may include blood work or imaging, ordered by your primary healthcare provider are needed to confirm if cancer is present.

What happens if I get a false positive?

If a diagnostic evaluation after a ​"Cancer Signal Detected" result with Galleri does not confirm cancer, you may be eligible for a complementary re-test with Galleri. The request for a...

If a diagnostic evaluation after a ​"Cancer Signal Detected" result with Galleri does not confirm cancer, you may be eligible for a complementary re-test with Galleri.

The request for a re-test must be placed by the healthcare provider who will order the re-test. The re-test must be administered within 3 - 6 months after the initial Galleri test. To initiate a request for a re-test, the healthcare provider managing your diagnostic evaluation should contact GRAIL Customer Service at 833-MY-GALLERI (833−694−2553) or customerservice@​grail.​com.

Who can see my test result?

The healthcare provider who orders the test will receive your test result and share it with you. Your test result and medical information are confidential, and access is limited to individuals who need the information for a specific...

The healthcare provider who orders the test will receive your test result and share it with you. Your test result and medical information are confidential, and access is limited to individuals who need the information for a specific purpose, such as the ordering provider and a GRAIL Patient Advocate. The ordering provider will help you understand your test results and determine your next steps. A GRAIL Patient Advocate can also provide post-positive test result support for diagnostic workup, benefits connectivity, assistance, and support with continuity of care / payer coverage assistance.

For example, if a cancer signal is detected, your test result may be shared with your primary healthcare provider so they can be aware and involved with your next steps.

Additional details about privacy and data use are included in the Galleri patient portal when you request the test.

Where can I get additional support regarding my Galleri test?

For questions about ordering the Galleri test, please contact your Summit doctor's office. For general questions on the Galleri test, please contact GRAIL Customer Service at (833) 694−2553 or by email at...

For questions about ordering the Galleri test, please contact your Summit doctor's office. For general questions on the Galleri test, please contact GRAIL Customer Service at (833) 694−2553 or by email at customerservice@​grail.​com.

Important Safety Information

The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 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 healthcare 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 healthcare 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 (CAP). 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.


References:

1. Klein EA, et al. Ann Oncol. 2021;32(9): 1167-1177. doi: 10.1016/j.annonc.2021.05.806.