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 https://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.