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The Galleri® Multi-Cancer Early Detection Test

The Galleri® test screens for over 50 types of cancers through a single blood test. Using advanced methylation technology, it analyzes 500,000 DNA sites to find a shared cancer signal across multiple types, including many without existing screening options.

$849

CompareMedsRx Exclusive Price

Powered by Stripe | Provided by GRAIL®

Buy Kit & Request Test north_east

The Galleri® Multi-Cancer Early Detection Test

The Galleri® test screens for over 50 types of cancers through a single blood test. Using advanced methylation technology, it analyzes 500,000 DNA sites to find a shared cancer signal across multiple types, including many without existing screening options.

$849

CompareMedsRx Exclusive Price

List Price $949

Powered by | Provided by GRAIL®

Buy Kit & Request Test

How to interpret your results

There are two possible test results:
● No Cancer Signal Detected
● Cancer Signal Detected

Nearly 99% of people who use the Galleri test, will screen negative — which is exactly what you want to hear. Around 1% of people ages 50-79 are expected to receive a Cancer Signal Detected test result. This result will include the predicted tissue type or organ associated with the signal, called a Cancer Signal Origin (CSO). After diagnostic evaluation, around 62% of these people are expected to have a confirmed cancer diagnosis.

The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood.

False positive and false negative results do occur.

The Galleri test should be used in addition to healthcare provider recommended screening tests.

Understanding a Cancer Signal Detected Result

The Galleri test detected DNA fragments associated with cancer in your blood sample. About 1 out of every 100 tests has a Cancer Signal Detected result.

Cancer Signal Detected result requires follow-up diagnostic testing. Such testing may include lab work or imaging ordered by your healthcare provider to confirm cancer.

This result will also include a prediction of the tissue type or
organ associated with the cancer signal, called a Cancer Signal Origin (CSO). This provides direction to your doctor on the cancer’s origin and can help guide the next steps for diagnosis.

In a clinical study, around 6 out of 10 people with this result were diagnosed with cancer after diagnostic testing.

If cancer is not confirmed, it could mean that cancer is not present or testing was not able to detect cancer, possibly because the cancer is located in a different part of the body.

Understanding a No Cancer Signal Detected Result

The Galleri test did not detect DNA fragments associated with cancer in your blood sample.
Nearly 99% of people who use the Galleri test will screen negative.

Continue with any routine cancer screenings your healthcare provider recommends. Do not ignore cancer signs or symptoms if they occur, as this could lead to a delayed diagnosis.

Kit Includes

Labels

Carton and exterior labels
Specimen Collection Instructions
Label Sheet
Galleri TRF
Quest Forms (Directive and TRF)
Patient Card

Components

2x Streck Tubes
Absorbent sleeve
Biohazard bag
Gel pack
Foil pouch

What is Galleri?

Galleri® is a multi-cancer early detection test that screens for many of the deadliest cancers through a simple blood draw—before symptoms appear. Unlike traditional cancer screenings that focus on one cancer at a time, Galleri can detect a signal from over 50 types of cancer with a single test, including many cancers that have no recommended screening available today.

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The Galleri test does not detect a signal for all cancers, and false positive or false negative results can occur. The Galleri test should be used in addition to healthcare provider recommended screening tests. The Galleri test does not predict future cancer risk. Rx only.

What is Galleri?

Galleri® is a multi-cancer early detection test that screens for many of the deadliest cancers through a simple blood draw—before symptoms appear. Unlike traditional cancer screenings that focus on one cancer at a time, Galleri can detect a signal from over 50 types of cancer with a single test, including many cancers that have no recommended screening available today.

This test is recommended for adults with an elevated risk for cancer, such as those age 50 or older.

● The Galleri test is available by prescription only.

● Use of the Galleri test is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.

The following lifestyle factors and health conditions may increase your risk for cancer:
□ Age 50 years or older
□ Personal history of cancer
□ Current smoker or history of smoking
□ Obesity
□ Diabetes
□ Family history of cancer (first degree relative)
□ Hereditary genetic predisposition (e.g. BRCA 1/2)
□ Occupational and toxic exposures (e.g. burn pits, asbestos)
□ Environmental exposures (e.g. alcohol consumption, sun
exposure)

□ Autoimmune chronic inflammatory conditions (e.g. IBD, asthma)
□ Non-autoimmune chronic inflammatory conditions (e.g. cirrhosis,
chronic hepatitis B/C)
□ Immunodeficiencies (e.g. primary or viral, such as HIV or HPV)
□ Solid organ transplantation

how-it-works-grail (1)

Cancers growing in the body shed DNA into the bloodstream. Although there are many types of cancer, the DNA fragments can act like a unique “fingerprint” of cancer.

The Galleri test screens for many of the deadliest cancers before they become symptomatic, including those without recommended screening
tests. The test results provide a predicted Cancer Signal Origin to help your healthcare provider determine the next steps for diagnosis.

In a clinical study, the Galleri test detected a signal shared by more than 50 types of cancer — including some fast-spreading and agressive cancers responsible for approximately two-thirds of cancer deaths. Galleri is a cancer screening test, meaning it looks for cancer before symptoms appear.

Receiving Test Kit: First, do not break the quality seal on your sample collection kit. The kit should be opened by the trained technician who draws your blood sample. Make sure you store it at room temperature until your blood draw appointment. The contents are sensitive to extreme temperatures. For example, avoid storing your collection kit in the trunk of your car for long periods of time.

There are two ways to schedule your blood draw:
1. Have a trained technician come to you, or
2. Visit one of Galleri's partner lab locations near you.

At your appointment, a trained technician will guide the next steps.

Things to note:

- No fasting is necessary for your blood draw – just remember to drink water to stay hydrated.

- The blood draw is available at no additional cost to you if it is done through a GRAIL partner lab.

- Within about two weeks after your sample is received at the GRAIL lab, you’ll receive your result by email.

where-to-test (1)

For your blood draw, you'll need these items:

- Unopened collection kit received by mail
- Your test requisition form received by email

You have the option to test at:

- One of Galleri's partner labs

- Your home, office, or any preferred location by a trained technician

You can select the best option for you

1. Request Your Test & Activate with Galleri Key

After purchase, your information will be reviewed to make sure the Galleri test is right for you. You’ll receive an email to let you know you qualify for the test, an access code called a Galleri Key, and a link that will direct you to the Galleri Portal. Here, you'll sign in with your Galleri Key, enter basic information, choose how to pay, and answer a few health questions.

2. Schedule & Complete Your Blood Draw

After submission, your blood collection kit will arrive at your home within 3-5 business days with everything needed for your appointment. You'll choose if you want to get your blood drawn at a partner lab or to have a lab tech visit your home. During your 15-minute appointment, a certified phlebotomist will collect a small blood sample—just like a routine blood test—and send it directly to the GRAIL lab for analysis.

Mary's Story
"So the only test that found that… was a Galleri test. And that's significant, that's huge."

Roger's Story
"I thought I was doing everything a person needed to do to stay healthy. So I had no idea that I was at risk for cancer."

Kevin's Story
"The impact of detecting this at an early stage opened the road for him to have a good chance at long-term survival."

The Galleri test screens for multiple cancers and can be taken annually as a simple blood draw. The test can screen for many aggressive cancers before symptoms appear. In a clinical study, the Galleri test detected a signal shared by more than 50 types of cancer. The Galleri test does not detect a signal for all cancers, and not all cancers can be detected in the blood. False positive and false negative results do occur. The Galleri test should be used in addition to healthcare provider-recommended screening tests.

Cancers growing in the body shed DNA into the bloodstream. Although there are many types of cancer, the DNA fragments act like a unique fingerprint of cancer. The Galleri test can screen for many aggressive cancers before they become symptomatic, including those with no recommended screening tests. With this unique "fingerprint" of cancer, the Galleri test helps to provide direction to your healthcare provider on the cancer’s origin and the next steps in diagnosis.

The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older. Use of the Galleri test is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.

In a clinical study, the Galleri test detected a signal shared by more than 50 types of cancer — including some fast-spreading and aggressive cancers responsible for approximately two-thirds of cancer deaths. Galleri is a cancer screening test, meaning it looks for cancer before symptoms appear.

Nearly 99% of people (ages 50-79) who take the Galleri test will receive a No Cancer Signal Detected result. In other words, approximately 1% are expected to receive a Cancer Signal Detected result. After diagnostic evaluation, around 62% of people with a Cancer Signal Detected result are expected to have a confirmed cancer diagnosis. Some of the ways we measure test accuracy are with positive predictive value (PPV) and a false positive rate. A PPV is the probability that a person with a Cancer Signal Detected test result has cancer (i.e., 62%). The false positive rate was 0.4% for participants without cancer.

No. A genetic or hereditary risk assessment is a one-time-only measurement and assesses your future risk of developing cancer. The Galleri test is a point-in-time test that identifies DNA in the bloodstream shed by active cancer cells.

On Comparemedsrx, the Galleri test is priced at $849, a $100 savings off the list price of $949.

The blood draw is included in the price if the test is scheduled with one of GRAIL’s lab partners. After purchasing the kit, you'll be directed to find a convenient time and location to schedule your blood draw at home or at a lab by a trained technician.

A limited number of health insurance plans currently cover the Galleri test. The test represents a significant innovation in cancer screening, and coverage with payers will continue to evolve over time. Patients may elect to pay for the test themselves and/or check with their insurer for coverage before requesting the test.

As each insurance company creates their own criteria for coverage of tests, you may need to work with your healthcare provider and your insurance company to obtain authorization prior to diagnostic testing. If you are unable to obtain coverage, contact a GRAIL patient advocate for additional help with care navigation and coordination with your healthcare provider.

When you’re ready to take the Galleri test, you can schedule your blood draw at a time and place convenient for you:

One of GRAIL's partner labs
Your home, office, or any preferred location by a trained technician

First, do not break the quality seal on your sample collection kit. The kit should be opened by the trained technician who draws your blood sample. Make sure you store it at room temperature until your blood draw appointment. The contents are sensitive to extreme temperatures. For example, avoid storing your collection kit in the trunk of your car for long periods of time.

The trained technician who draws your blood will pack and ship your sample back to the GRAIL laboratory for processing.

No fasting is required for the Galleri test.

Approximately 1.5 tablespoons (or about 20 mL) of blood in two tubes is typically drawn from a vein in your arm.

If you no longer wish to receive your Galleri test result, contact GRAIL Customer Service by completing the online form on their Contact Us web page or by calling (833) 694‑2553.

If your test has already been processed by the GRAIL laboratory, you will be responsible for the cost of the test.

Typically, you can expect to receive your test result about 2 weeks after your sample arrives at the GRAIL lab. In certain cases, results may take up to 4 weeks.

If you have not received your result within 2 weeks, GRAIL will notify you via email (sent to your email address if one was provided on your Test Requisition Form).

It is important to understand that the timing of your test result does not indicate or predict the outcome of the test, nor does it impact the accuracy of the final result.

All patients will include an email with their order request and receive an emailed result.

The Galleri test detected DNA methylation patterns often associated with cancer in your blood sample. About 1 out of every 100 tests has a Cancer Signal Detected result.

This result will also include a prediction of the tissue type or organ associated with the cancer signal, called a Cancer Signal Origin (CSO). The CSO helps your doctor determine the next steps for diagnosis.

A healthcare provider should interpret the results. The test result is not a cancer diagnosis and requires follow-up diagnostic testing, which may include lab work or imaging ordered by your healthcare provider to confirm cancer. GRAIL also offers patients and providers additional support and resources if needed to help guide the next steps.

The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood. False positive and false negative results do occur.

The Galleri test did not detect DNA methylation patterns associated with cancer in your blood sample. Nearly 99% of people who use the Galleri test will receive a No Cancer Signal Detected result.

This result does not completely rule out the possibility of cancer, and you should continue with other cancer screenings your provider recommends. While the Galleri test is a powerful tool, it cannot detect a signal for all cancers and not all cancers can be detected in the blood. Some cancers shed little or no DNA into the bloodstream, which makes them unlikely to be detected through a blood test (e.g., brain, skin, and early breast and prostate cancers). False positive and false negative results do occur. The Galleri test identifies DNA in the bloodstream shed by cancer cells and does not predict future genetic risk for cancer.

The Galleri test can be taken as an annual blood test. Adding the Galleri test to yearly wellness visits can improve your chance of finding a cancer signal early, when more treatment options may be available. Ask your healthcare provider when it is best to test again.

Cancer can be unpredictable. The Galleri test can be taken annually and added to your yearly wellness visits. Aggressive cancers can develop and progress quickly, sometimes in less than a year. Ask your healthcare provider when would be the best time to schedule your next test.

The Galleri test is intended to be used in addition to — and not replace — other cancer screening tests your healthcare provider recommends. Single-cancer screening tests are recommended because they have been proven to save lives by detecting cancer early. Adding the Galleri test to annual wellness visits can improve your chance of finding a cancer signal early when more treatment options may be available.

The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood.

A Cancer Signal Detected test result is not a cancer diagnosis and requires follow-up diagnostic testing to confirm cancer. Follow-up diagnostics may include lab work or imaging ordered by your healthcare provider to confirm cancer.

Important Safety Information

The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 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 Galleri test is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of the test 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

The GRAIL 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. The GRAIL clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.