What if We Found Cancer Early Enough to Make a Difference

The Galleri® multi-cancer early detection test detects a cancer signal across more than 50 types of cancer.1,2 It’s now available to eligible Illumina employees and their dependents. To learn more about this benefit, please watch our recorded webinar. View now.

Individuals must meet the clinical eligibility criteria determined by Genome Medical to receive the test.

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Finding Cancer Early is Important

Thinking about the possibility of having cancer can be overwhelming, but taking steps to find cancer early can help you feel more in control. Often, the earlier that cancer can be found, the higher the chance of better outcomes.3 70% of cancer deaths in people ages 50-79 are caused by cancers not commonly screened for.4,5,6 In fact, when cancers are diagnosed early before they have had a chance to spread, the overall 5-year survival rate is 4x higher than when diagnosed in later stages.3,7

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Galleri Multi-Cancer Early Detection Test

The Galleri test, GRAIL’s multi-cancer early detection test, detects a cancer signal across more than 50 types of cancer, many of which are not commonly screened for today. All that’s required is a simple blood draw.1,2,8

Eligible Illumina employees have access to the Galleri test as an annual benefit, which includes clinical eligibility confirmation and test review by a Genome Medical physician. Annual eligibility is based on a rolling calendar year from when your test results were completed and reported to you.

Request the Galleri test

Benefit Requirements & Eligibility

This employee benefit through Illumina and Genome Medical provides eligible employees access to the Galleri multi-cancer early detection test as an annual benefit. Annual eligibility is based on a rolling calendar year from when your test results were completed and reported to you. If you received Galleri test results in the past, Genome Medical will notify you once you’re eligible to request the test again. Genome Medical’s team of oncology experts has reviewed risk factors that increase a person’s chance to develop cancer to determine who would benefit from the Galleri test. The current criteria are not meant to represent a comprehensive list of all cancer risk factors but are a starting point to offer the Galleri test.

Between the Ages of 22-49

Certain risk factors may put you at an elevated risk for developing cancer. The Galleri test may be right for you if you meet one or more of the following criteria:

  • You have a history of cancer (excluding basal or squamous cell carcinomas of the skin) and are more than three years out of treatment. A consultation with a genetic counselor is required if you have had a personal history of cancer and are more than three years out of treatment.
  • You have a first degree relative (parent, child and/or full sibling) who has had cancer.
  • You are a smoker or have quit smoking in the last 10 years.
  • You had previous genetic testing and were found to have a gene mutation confirming an increased cancer risk due to a hereditary cancer syndrome (e.g., BRCA1/2, Lynch syndrome, CHEK2). Please note that a clinical report from an accredited laboratory that performs clinical grade genetic testing is required; this excludes tests from 23andMe, Ancestry.com and other direct to consumer genetic testing companies. A consultation with a genetic counselor is required if you have had a previous gene mutation in order to confirm the finding.

Request the Galleri test to see if you’re eligible

50 or Older

The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The risk of cancer increases as we age, so individuals 50 or older are eligible for the Galleri Test.

Request the Galleri test to see if you’re eligible

Not Eligible At This Time

Currently, the following individuals are not eligible for the Galleri test:

  • You have been diagnosed or treated for cancer within the past three years
    • This excludes basal or squamous cell carcinomas of the skin
    • This also excludes hormonal therapy (e.g., Tamoxifen, Arimidex, Aromasin) for breast cancer; you need to be 3 years past surgery, chemotherapy and/or radiotherapy but can still be taking hormonal therapy
  • You are currently pregnant
  • You are 21 years old or younger
  • You live outside of the United States; Genome Medical is not able to order testing for people who reside outside the US

The Benefits of Multi-Cancer Detection

The Galleri test is intended to be used in addition to, and not replace, other cancer screening tests your health care provider recommends. The Galleri test does not detect all cancers nor does it measure your genetic risk of developing cancer in the future. The Galleri test is a screening test and does not detect all cancers. Further testing is needed to diagnose cancer if a signal is detected.

Early cancer detection

Detects many cancers not commonly screened for today, to allow for earlier treatment.1,8

Testing with ease

Completed with a simple blood draw.

Icon for test results. Actionable results

If a cancer signal is found, the results can point to where in the body the cancer is coming from.

Test Process

Follow the process with just three steps.

Ordering the Galleri test

The Galleri test must be ordered by a health care provider. If you’re ready to request the test, you’ll be asked to answer a few questions and a Genome Medical physician will review your information and determine if the test is right for you.

To learn more about clinical eligibility before requesting the test, please click here.

Request the Galleri test

Get a Blood Draw

If your test has been authorized by your Genome Medical physician, a Galleri collection kit will be mailed directly to you with directions on how to locate a partner laboratory to have your blood drawn. Please do not open the kit. You must take the kit to the lab unopened.

Make sure you have the following in hand for your blood draw:

    1. Your Galleri Collection kit. It will be shipped directly to you.
    2. Your completed and printed Test Requisition Form. GRAIL will email this to you after your test has been authorized by Genome Medical.

If you are a current patient who has questions about scheduling a blood draw, please find more information here or contact GRAIL Customer Service at 833-694-2553 or customerservice@grail.com.

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Receive Your Results

Your results will be available approximately two weeks after your sample arrives at the GRAIL laboratory. At that time, Genome Medical will contact you via email or phone to review your test results and discuss next steps. Additionally, you’ll have the option to schedule a return of results session to further discuss your results. Once you receive your results, it’s important to share your results and clinical action plan with your primary care physician.

The test does not measure your genetic risk of developing cancer in the future. With the Galleri multi-cancer early detection test, annual screening provides the opportunity to detect more cancers early.

False-positive and false-negative test results can occur. The Galleri test has a low false-positive rate of 0.5% (detecting a cancer signal when no cancer is present).1

Breakthrough Test Performance

sensitivity*

This means that the Galleri test reported a “Cancer Signal Detected” result in approximately 52 individuals out of 100 who actually had cancer.1

specificity

This means that the Galleri test reported a “Cancer Signal Not Detected” result in approximately 99 individuals out of 100 who do not actually have cancer.1

false positive rate

This means that the Galleri test reported a “Cancer Signal Detected” result 1 in every 200 tests run in individuals who did NOT actually have cancer.1

Cancer Signal Origin Accuracy

This means when a cancer signal was detected in an individual who actually had cancer, the first Cancer Signal Origin was correctly predicted in 89 of 100 times.1

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Request the Galleri test

The Galleri multi-cancer early detection test detects a cancer signal across more than 50 types of cancer.1,2 It’s now available to eligible Illumina employees and their dependents.

Frequently Asked Questions

Illumina has partnered with Genome Medical to offer our employees and their dependents access to genomic education and experts through chat, phone or email. Genome Medical provides educational and health-related information that progresses the understanding of genomics and helps employees get answers on a variety of questions. General genetic questions or more detailed personalized inquiries can be answered by the Genome Medical clinical team.

The first Illumina employee sequencing program launched in 2014 and we have learned a lot since then. We have seen the marketplace for sequencing tests and screenings explode, while at the same time, employees expressed the need for education as a first step in their genomics journey. We have also witnessed the power of genetic counseling and doctor-to-doctor consultations to advance patient understanding and care. Illumina is excited to have partnered with Genome Medical to launch our workplace genomics program.

BETWEEN THE AGES OF 22-49?

Certain risk factors may put you at an elevated risk for developing cancer. The Galleri test may be right for you if you meet one or more of the following criteria:

  • You have a history of cancer (excluding basal or squamous cell carcinomas of the skin) and are more than three years out of treatment. A consultation with a genetic counselor is required if you have had a personal history of cancer and are more than three years out of treatment.
  • You have a first degree relative (parent, child and/or full sibling) who has had cancer.
  • You are a smoker or have quit smoking in the last 10 years.
  • You had previous genetic testing and were found to have a gene mutation confirming an increased cancer risk due to a hereditary cancer syndrome (e.g., BRCA1/2, Lynch syndrome, CHEK2). Please note that a clinical report from an accredited laboratory that performs clinical grade genetic testing is required; this excludes tests from 23andMe, Ancestry.com and other direct to consumer genetic testing companies. A consultation with a genetic counselor is required if you have had a previous gene mutation in order to confirm the finding.

50 OR OLDER?

The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The risk of cancer increases as we age, so individuals 50 or older are eligible for the Galleri Test.

CURRENTLY, THE FOLLOWING INDIVIDUALS ARE NOT ELIGIBLE FOR THE GALLERI TEST:

  • You have been diagnosed or treated for cancer within the past three years
    • This excludes basal or squamous cell carcinomas of the skin
    • This also excludes hormonal therapy (e.g., Tamoxifen, Arimidex, Aromasin) for breast cancer; you need to be 3 years past surgery, chemotherapy and/or radiotherapy but can still be taking hormonal therapy
  • You are 21 years old or younger
  • You are currently pregnant
  • You live outside of the United States; Genome Medical is not able to order testing for people who reside outside the US

In order to receive the test and genetic counseling at no cost, you must request the test through the Illumina and Genome Medical employer program.

The Galleri test is not yet commercially available outside of the United States.

You can schedule a genetic counseling consultation to review your personal and family history to confirm eligibility and if criteria is met, Genome Medical will order the Galleri test for you. If you do not meet criteria, your genetic counselor can review alternative cancer screening options or genetic testing. Schedule a 1:1 consultation with a Genome Medical genetic counselor by visiting www.genomemedical.com/programs/illumina/.

The Galleri test is only available for no cost for employees and their dependents (spouses/domestic partners and children) that meet clinical eligibility requirements. All other family members can learn more and request the test by visiting www.www.genomemedical.com/galleri. The cost of the test and provider services will be paid for by the family member(s).

The Galleri test is not available to people that are currently pregnant. Pregnant people who meet the clinical eligibility criteria may take the test once the pregnancy is complete.

The Galleri test is offered annually, and eligibility is based on a rolling calendar year from when your test results were completed and reported to you. If you received Galleri test results in the past, Genome Medical will notify you once you’re eligible to request the test again.

The Galleri test is a multi-cancer early detection test that detects more than 50 types of cancer, many of which are not commonly screened for today, through a simple blood draw. The Galleri test does not diagnose cancer and not all cancers may be detected by the test.

In a large-scale clinical evaluation sub-study of more than 5,000 people, the Galleri test detected more than 50 cancer types across all stages. The test identified ~17% stage I cancer, 40% with stage II cancer, 77% stage III cancer and 90% of stage IV cancers.

The Galleri test screens for more than 50 cancers; however, not all cancers may be detected by the test. Recommended routine cancer screening tests, such as a colonoscopy or mammogram are commonly used and have been shown to reduce cancer deaths. Galleri is intended to be used in addition to, not to replace, these tests and can help maximize the benefits of early cancer detection. Missing recommended screening or ignoring symptoms could lead to a delayed diagnosis of cancer. Ask Genome Medical about which cancer screening tests are right for you.

Results should be available to your ordering provider within 10 business days (Mon — Fri, excluding holidays) from the time your sample was received at the GRAIL laboratory. Your sample will arrive at the laboratory 1-2 business days after your blood draw.

At that time, Genome Medical will contact you via email or phone to schedule an optional genetic counseling session to review your test results and discuss the next steps. Once you receive your results, it’s important to share your results and clinical action plan (which will be provided by Genome Medical) with your primary care provider.

This means that no cancer signal was found. Not all cancers can be detected by the Galleri test. You should continue with all routine screening tests that your healthcare provider recommends. Missing routine cancer screenings or ignoring symptoms could lead to a delayed diagnosis of cancer.

The Galleri test does not diagnose cancer but indicates a suspicion that you may have cancer. The Galleri test can point to where in the body the cancer may be coming from, for example the lung or liver, to help your healthcare provider guide your next steps. Illumina has partnered with Included Health to connect you with expert healthcare providers, in addition to your primary care provider, who can order additional tests to determine if cancer is present.

Additional tests are required to confirm whether you have cancer. The tests ordered by a healthcare provider are needed to confirm if cancer is present which may include a combination of blood work or imaging studies. Genome Medical will provide recommendations for which tests are needed.

Insurance coverage for bloodwork and imaging studies is generally covered by insurers when there is an indication or reason to order them. Since the Galleri test is a new test, it is possible that your insurance may not cover some of the additional tests. Illumina, GRAIL and Genome Medical can provide resources that may help your provider show medical necessity for coverage for additional tests, but coverage cannot be guaranteed.

For employees with insurance coverage through the Blue Shield plan, if any advanced imaging (MRI, CT, PET/CT scan) is recommended, please contact Collective Health at 1-833-743-3223 and make them aware of the imaging test(s) that is being recommended. Collective Health will contact Blue Shield to preemptively approve the imaging test(s) so that Blue Shield does not deny the claim once it is submitted.

The test does not measure your genetic risk of developing cancer in the future and is instead looking for the presence of a cancer signal at the time your blood is drawn. You may develop cancer in the future which is why the Galleri test may be ordered more than once. Your healthcare provider at Genome Medical is the best person to determine when to take the Galleri test again as a part of your routine screening based on any underlying risk factors or previous test results.

Yes. Genome Medical can share your Galleri test results with your healthcare providers.

In a large-scale clinical study, the Galleri test had 51.5% sensitivity for all cancers and 76.3% sensitivity in cancers that cause two-thirds of cancer deaths in the US (anus, bladder, colon/​rectum, esophagus, head and neck, liver/​bile duct, lung, lymphoma, ovary, pancreas, plasma cell neoplasm, and stomach).3,5 Sensitivity measures how often the test correctly identifies the cancer signal when cancer is present (also known as the true positive rate).

The Galleri test had a specificity of 99.5% or false-positive rate of 0.5%, meaning in approximately 200 people tested, only 1 person received a false positive result (a false positive is a test result of “Cancer Signal Detected” when cancer is not present).3

When the Galleri test detects a cancer signal, it also predicted where the cancer was located with high accuracy and was correct 89% of the time in a clinical validation sub-study.3

Yes. You have the option to speak with a Genome Medical board-certified genetic counselor, at no cost to you, before and after the test is ordered.

Once your test has been authorized by your Genome Medical physician, a Galleri collection kit will be mailed directly to you with directions on how to locate a laboratory to have your blood drawn. You will need to bring the following with you:

  1. Your Galleri collection kit
    Will be shipped directly to you
  2. Your completed and printed Test Requisition Form
    GRAIL will email this to you after your test has been authorized by Genome Medical. Must be printed and brought to your blood draw appointment.

To locate a laboratory near you, visit www.galleri.com/locate-lab.

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

No preparation or fasting is required for the Galleri test.

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

There is no cost for employees and their dependents (spouse/domestic partner and children) to access education or genetic counseling services through Genome Medical. However, employees and their dependents (spouse/domestic partner and children) will be responsible for the cost of any genetic tests with the exception of the TruGenome™ UDD Test (the test used for RUGD cases), Foundation Medicine cancer test or the Galleri multi-cancer early detection test – clinical eligibility requirements must be met to access these tests at no cost. When medically appropriate, genetic testing will be billed to your health insurance.

All regular US-based Illumina employees and their dependents (spouses/domestic partners and children) in the United States who meet clinical eligibility may access the test at no cost. Clinical eligibility is currently age 50 years or older or those who are between the ages of 18-49 who have an elevated risk of developing cancer. Eligible employees and their dependents (spouse/domestic partner and children) between the ages of 18-49 may be eligible to receive the test at no cost if any of the elevated risk criteria below are met. If you meet these criteria and you’re interested in the Galleri test, a genetic counseling consultation with one of Genome Medical’s genetic counselors is required. During this session, your personal and family history will be reviewed to confirm eligibility and if criteria are met, Genome Medical will order the Galleri test for you.

Identified Gene Mutation: you had previous genetic testing and were found to have a gene mutation confirming an increased cancer risk due to a hereditary cancer syndrome (e.g., BRCA1/2, Lynch syndrome, CHEK2). Please note that a clinical report from an accredited laboratory that performs clinical grade genetic testing is required; this excludes tests from 23andMe, Ancestry.com and other direct to consumer genetic testing companies.

Prior Cancer: you previously had cancer and completed treatment; excludes basal or squamous cell carcinoma of the skin

Direct Biological Family History of Cancer: you have a biological parent, child, and/or a full brother or sister who has had cancer and falls within one of the criteria below:

  • the relative was diagnosed under the age of 50
  • the relative has had more than one cancer excluding a basal or squamous cell carcinoma of the skin and/or the second cancer is not a recurrence or metastasis of the first cancer
  • or the relative passed away from cancer

The Galleri test is currently not available outside of the US.

If you’re over the age of 50 or meet clinical criteria of being at an elevated risk of developing cancer a genetic counseling consultation is NOT required.

However, if you have had previous genetic testing and were found to have a gene mutation confirming an increased cancer risk due to a hereditary cancer syndrome (e.g., BRCA1/2, Lynch syndrome, CHEK2) a consultation with a genetic counselor is required. Please note that a clinical report from an accredited laboratory that performs clinical grade genetic testing is required; this excludes tests from 23andMe, Ancestry.com and other direct to consumer genetic testing companies.

Yes. You have the option to speak with a Genome Medical board-certified genetic counselor, at no cost to you, before and after the test is ordered. Our GCs have been educated on the Galleri test and can provide guidance on the test and results.

There is no cost to speak with a Genome Medical board-certified genetic counselor through this program and employee benefit. Our GCs have been educated on the Galleri test and can provide guidance on the test and results.

During your post-test consultation you will meet with a Genome Medical board-certified genetic counselor via video or phone. Your genetic counselor will:

  • Review your Galleri test results.
  • Provide a clear understanding of what your results mean for you. The Galleri test does not measure your genetic risk of developing cancer in the future. The Galleri test looks for DNA changes in the blood that may be associated with cancer at the time of your blood draw.
  • Develop a clinical action plan for your ongoing care that you can share with your physician.
  • Learn about recommended next steps.

Illumina takes patient privacy seriously. Illumina, Genome Medical and the GRAIL Laboratory will maintain the health information in compliance with all applicable medical privacy laws, including HIPAA, GINA, etc. Genome Medical will not share any health information with Illumina. Use of the Genomics Resource Center is confidential.

Additional 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.

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.