Screening for multiple cancers is now possible with Galleri®

Harvard Pilgrim Health Care, a Point32Health company, and Dana-Farber are excited to announce a limited pilot program providing access to the Galleri multi-cancer early detection test from GRAIL.

The Galleri test is the first-of-its-kind – a test that looks for a signal shared by more than 50 types of cancer with a single blood test.1

Eligible staff and faculty and their dependents aged 50 years and older who are enrolled in a Dana-Farber-employee health plan and who also meet clinical eligibility criteria can now request the Galleri test.

There are a limited number of tests available for this pilot. Please review the eligibility requirements below.

The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood. Galleri should be used in addition to healthcare provider recommended screening tests.

white man with short gray hair in gray top and jeans sitting on a couch in front of an open window with his arm around a blonde woman in blue jumpsuit

The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood. Galleri should be used in addition to healthcare provider recommended screening tests.

Key benefits of the Galleri test

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Screening for more cancers

Added to recommended screening, the Galleri test improves your chance to find cancer early. It detects a signal shared by dozens of cancers including many that don't have screening tests.1

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Testing with ease

Screen with a simple blood draw easily added to your cancer screening plan.

No fasting or preparation required.

Test requires a prescription from an independent telemedicine provider

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Actionable results

If a cancer signal is found, results can predict the tissue type or organ associated with the cancer signal. This helps your healthcare provider guide next steps to determine if cancer is present.1

The Galleri test looks for a signal associated with 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. False positive and false negative results do occur. Galleri should be used in addition to screening tests your healthcare provider recommends.

Who is eligible?

All Dana-Farber staff and faculty and their dependents (spouses, domestic partners, etc.) must meet the following program eligibility requirements before requesting the Galleri test.

For this pilot program, there are a limited number of tests available on a first-come, first-served basis.

Under the program, the cost of the Galleri test is included. For certain services related to the test, co-pays, deductibles, and co-insurance may apply.

Eligibility requirements: 

  • Reside in the United States
  • Aged 50 years old and older
  • Enrolled in a Dana-Farber-employee health plan through Harvard Pilgrim Health Care
  • Not currently pregnant
  • Not currently undergoing active cancer treatment, though history of cancer* with treatments completed at least 3 years ago is permitted

AND also meet at least one of the following clinical criteria:

  • Either a first-degree relative (biological parent, adult child, or sibling) or a second-degree relative (grandparent, aunt/uncle, niece/nephew, etc.) with cancer*
  • Cancer survivor* who has completed treatment at least 3 years ago
  • Currently smokes cigarettes or quit smoking fewer than 10 years ago
  • Elevated body mass index
    • Female ≥ 30 kg/m2
    • Male ≥ 35 kg/m2

* excludes basal or squamous cell carcinoma of the skin

Please note, under the pilot program, the cost of the Galleri test is included. The cost of the blood draw is also included if it is completed at a GRAIL blood draw event or at a GRAIL partner laboratory.

In the event of a “Cancer Signal Detected” Galleri test result, the program does not cover or pay for follow-up consults and diagnostic procedures (e.g., imaging, biopsies, other laboratory tests, etc.) that the ordering provider may recommend for you. You may incur cost-share expenses such as co-pays, deductibles, and co-insurance. Please contact Member Services via the phone number listed on the back of your Harvard Pilgrim Health Care Member ID card to determine covered expenses and your potential costs related to follow-up procedures that your provider may recommend.

Black couple sitting at their kitchen table writing on a notepad with a cup of coffee and a tablet on the table in front of them

There are two ways to access the test at no cost to you

Galleri is available by prescription only. The cost of the test is included if you request the test from an independent telemedicine provider at PWNHealth through the two ordering options below.

Act now – for this pilot program, there are a limited number of tests available on a first-come, first-served basis.

IMPORTANT - To request the test, you will need an Access ID. Your Access ID is your Harvard Pilgrim Health Care Member ID number, which can be found on the front of your insurance card. NOTE - when entering your Member ID number do not include any dashes (Example: HP123456700).

Onsite Blood Draw Events

Important - only Dana-Farber staff and faculty can schedule appointments for the onsite events.

Recommended for staff and faculty who work on-site in Longwood or Chestnut Hill.

Sign up for your Galleri appointment.

Longwood Campus

  • May 21-22 and June 4-5
  • Room: Yawkey 304

Chestnut Hill Campus

  • May 23 and June 3
  • Room: CH3306 and CH3307

Please note - once your appointment is set, the scheduler page will prompt you to complete a health questionnaire to request the test from a PWNHealth telemedicine provider. Please use your Harvard Pilgrim Health Care Member ID number (do not include any dashes) when prompted to enter your Access ID.

OR

Request from our partner telemedicine provider

Recommended for staff and faculty who do not work in Longwood or Chestnut Hill, as well as for dependents.

Our partner telemedicine provider from PWNHealth will confirm your eligibility and order the Galleri test for you if appropriate.

If the PWNHealth provider approves your request, a Galleri collection kit will be shipped to you.

You’ll receive an email with information on how to schedule and complete your blood draw at a local GRAIL partner lab.

For this pilot program, the cost of the test is included if you request the test from an independent telemedicine provider at PWNHealth through the two program ordering options provided.

The cost of the blood draw is also included if it is completed either at a Dana-Farber onsite blood draw event or at a GRAIL partner laboratory (i.e. Quest and GetLabs). If you choose to complete the blood draw at another lab or office, you will be responsible for the blood draw fee.

Only the blood draw occurs at the local event. Samples are processed at GRAIL's clinical laboratory.

Our testing process

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Request the test

You have options to request the test from an independent telemedicine provider at PWNHealth.

  1. Request the test and schedule an appointment at an upcoming Galleri blood draw event.
    OR

  2. An online request through a telemedicine provider at PWNHealth.
illustrated graphic of the Galleri test box sitting on a table in front of a window

Test order & collection kit

Your eligibility, as well as medical and family history will be reviewed by the ordering provider. They will order the test if appropriate.

For those not attending the onsite event, if the telemedicine provider orders your test, GRAIL will ship you a Galleri collection kit for you to complete your blood draw.

illustrated graphic of a white, gray haired female patient having her blood drawn

Provide your sample

Complete your blood draw either at:

For this program, the cost of the blood draw is included if it’s completed through either of these options. If you choose to complete the blood draw at another lab or office, you will be responsible for the blood draw fee.

Illustrated graphic of a black man sitting in a blue armchair and reviewing test results on a tablet

Receive your results

The ordering provider from PWNHealth will reach out via a secure patient message or phone to share your results – about 2 weeks after your blood draw sample arrives at the GRAIL lab. The ordering provider will coordinate with your primary care provider if needed.

In the event of a Cancer Signal Detected test result, the Dana-Farber Multi-Cancer Early Detection Clinic can assist in the diagnostic workup to confirm if cancer is present. Call 617-762-2334 to make an appointment.

IMPORTANT —  In the event of a “Cancer Signal Detected” Galleri test result, the pilot program does not cover or pay for follow-up consults and diagnostic procedures (e.g., imaging, biopsies, other laboratory tests, etc.) that the ordering provider may recommend for you. You may incur cost-share expenses such as co-pays, deductibles, and co-insurance. Please contact Member Services via the phone number listed on the back of your Harvard Pilgrim Health Care Member ID card to determine covered expenses and your potential costs related to follow-up procedures that your provider may recommend. Under the pilot program, the cost of the Galleri test is included. The cost of the blood draw is also included if it is completed at a GRAIL blood draw event or at a GRAIL partner laboratory.

What is the Galleri test?

Galleri is the first-of-its-kind multi-cancer early detection test—a test that looks for a signal shared by more than 50+ types of cancer with a single blood test. It is a screening test and does not diagnose cancer, further testing is required to confirm cancer.

illustrated video poster of the Galleri test sitting on a table in an examination room with an anatomy poster on the wall behind it

What do Galleri test results mean?


What does a “No Cancer Signal Detected” result mean?

The Galleri test looked for a cancer signal in your blood sample and did not find one.

In a clinical study, less than 2% of individuals with a No Cancer Signal Detected result had cancer.1,2

This result does not completely rule out the possibility of cancer. The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood. This result does not predict whether you will develop cancer in the future.

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NEXT STEPS

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.

What does a “Cancer Signal Detected” result mean?

The Galleri test looked for a cancer signal in your blood sample and found one. About 1 out of every 100 tests has a Cancer Signal Detected result.2*

This result will also include one or two predictions of the tissue type or organ associated with the cancer signal, called ​"Cancer Signal Origin."

In a clinical study, around 4 out of 10 people with this result were diagnosed with cancer after diagnostic testing.2


*In the PATHFINDER study2, out of 6,578 participants tested with Galleri, 58 had a Cancer Signal Detected result.

cancer signal origin image

Other: Anus, Bone and Soft Tissue, Head and Neck, Lymphoid Lineage, Melanocytic Lineage, Myeloid Lineage, Neuroendocrine Cells of Lung or other Organs, Plasma Cell Lineage, Thyroid Gland, Uterus.

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NEXT STEPS

A Cancer Signal Detected 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.

In the event of a Cancer Signal Detected test result, the Dana-Farber Multi-Cancer Early Detection Clinic can assist in the diagnostic workup to confirm if cancer is present. Call 617-762-2334 to make an appointment.

IMPORTANT —  In the event of a “Cancer Signal Detected” Galleri test result, the pilot program does not cover or pay for follow-up consults and diagnostic procedures (e.g., imaging, biopsies, other laboratory tests, etc.) that the ordering provider may recommend for you. You may incur cost-share expenses such as co-pays, deductibles, and co-insurance. Please contact Member Services via the phone number listed on the back of your Harvard Pilgrim Health Care Member ID card to determine covered expenses and your potential costs related to follow-up procedures that your provider may recommend. Under the pilot program, the cost of the Galleri test is included. The cost of the blood draw is also included if it is completed at a GRAIL blood draw event or at a GRAIL partner laboratory.

General support

For questions about requesting the Galleri test for this program, please contact Dana-Farber HR-Benefits at askhr@dfci.harvard.edu.

For questions about the Galleri test and the Galleri blood draw event, please contact GRAIL Customer Service at 833−694−2553 or by email at customerservice@grail.​com.

For questions regarding your Harvard Pilgrim Health Care plan please contact Member Services via the phone number listed on the back of your member ID card.

Frequently Asked Questions

All Dana-Farber staff and faculty and their dependents (spouses, domestic partners, etc.) must meet the following program eligibility requirements before requesting the Galleri test.

For this pilot program, there are a limited number of tests available on a first-come, first-served basis.

Under this limited pilot program, the cost of the Galleri test is included. For certain services related to the test, co-pays, deductibles, and co-insurance may apply.

Eligibility requirements

  • Reside in the United States
  • Aged 50 years old and older
  • Enrolled in a Dana-Farber-employee health plan through Harvard Pilgrim Health Care
  • Not currently pregnant
  • Not currently undergoing active cancer treatment, though history of cancer* with treatments completed at least 3 years ago is permitted

AND also meet at least one of the following clinical criteria:

  • Either a first-degree relative (biological parent, adult child, or sibling) or a second-degree relative (grandparent, aunt/uncle, niece/nephew, etc.) with cancer*
  • Cancer survivor* who has completed treatment at least 3 years ago
  • Currently smokes cigarettes or quit smoking fewer than 10 years ago
  • Elevated body mass index
    • Female ≥ 30 kg/m2
    • Male ≥ 35 kg/m2

* Excludes basal or squamous cell carcinoma of the skin.

Please note, under the pilot program, the cost of the Galleri test is included. The cost of the blood draw is also included if it is completed at a GRAIL blood draw event or at a GRAIL partner laboratory.

In the event of a “Cancer Signal Detected” Galleri test result, the program does not cover or pay for follow-up consults and diagnostic procedures (e.g., imaging, biopsies, other laboratory tests, etc.) that the ordering provider may recommend for you. You may incur cost-share expenses such as co-pays, deductibles, and co-insurance. Please contact Member Services via the phone number listed on the back of your Harvard Pilgrim Health Care Member ID card to determine covered expenses and your potential costs related to follow-up procedures that your provider may recommend.

For this program, all eligible members and their dependents (spouses, domestic partners, etc.) must be enrolled in the Dana-Farber-employee health insurance plan through Harvard Pilgrim Health Care.

The Galleri test is available by prescription only. For the two ordering options available, Galleri must be ordered by an independent telemedicine provider from PWNHealth. They will review your request and order the test, if appropriate.

  • You can request the test for upcoming onsite blood draw events. Review the Dana-Farber events details to request the test before the event and schedule an appointment. Please note, only Dana-Farber staff and faculty can schedule appointments for these events.
    OR
  • Online through PWNHealth, an independent telemedicine provider, at Galleri.com/dfci-pilot. A collection kit will then be shipped to you to complete your blood draw. This option is recommended for staff and faculty who do not work in Longwood or Chestnut Hill and for eligible dependents/spouses.

For this pilot program, there are a limited number of tests available on a first-come, first-served basis.

For this pilot program, there are a limited number of tests available on a first-come, first-served basis.

If your test request is approved and ordered by the PWNHealth telemedicine provider, please complete your Galleri test blood draw by December 1, 2024.

To request the test, you will need an Access ID. Your Access ID is your Harvard Pilgrim Health Care Member ID number, which can be found on the front of your insurance card. IMPORTANT - when entering your Member ID number do not include any dashes (Example: HP123456700).

Yes, if you have a history of cancer, you must not currently be receiving active cancer treatment and you must have completed cancer treatment at least 3 years ago.*

* excludes basal or squamous cell carcinoma of the skin.

The cost of the Galleri test, blood draw, and laboratory fees are covered under this limited-time pilot program for eligible staff and faculty and dependents.

Please note, the cost of the blood draw is included if it is completed at a GRAIL blood draw event or at a GRAIL partner laboratory. An at-home blood draw is also included if scheduled with one of our partner labs. Find a time and location convenient for you at Galleri.com/schedule.

Additionally, the Galleri test blood draw must occur on a date you are covered under this employee benefit. Staff and faculty are responsible for the full cost of the test when obtained via any other means such as a personal physician or when the blood draw date of service occurs after your Dana-Farber health plan coverage has ended.

Under the pilot program, the Galleri test is provided at no cost. The cost of the blood draw is also included if it is completed at a GRAIL partner laboratory.

The program does not cover or pay for the Galleri pre-test consult or the blood draw with an ordering provider from Dana-Farber. In the event of a ​“Cancer Signal Detected” Galleri test result, the program also does not cover or pay for follow-up consults and diagnostic procedures (e.g., imaging, biopsies, other laboratory tests, etc.) that the ordering provider may recommend for you. You may incur cost-share expenses such as co-pays, deductibles, and co-insurance. Please contact Member Services via the phone number listed on the back of your Harvard Pilgrim Health Care Member ID card to determine covered expenses and your potential costs related to follow-up procedures that your provider may recommend.

Additionally, the blood draw associated with Galleri must occur on a date you are covered under this pilot program. Staff and faculty are responsible for the full cost of the test when obtained via any other means such as a personal physician or when the blood draw date of service occurs after your Dana-Farber health plan coverage has ended.

GRAIL is a health care company pioneering new technologies for early cancer detection. GRAIL is the company that manufactures the Galleri multi-cancer early detection test. You may receive information or communications from GRAIL or Galleri about your benefit or the Galleri test.

For this pilot program, to access the Galleri test as a fully covered offering, you must request the test from PWNHealth, the independent telemedicine provider, via Galleri.com/dfci-pilot.

Yes, you can request Galleri online through an independent telemedicine provider for $949. Click here to start your test request process.

Alternatively, you can request the test through the Dana-Farber Multi-Cancer Early Detection Clinic for $799. Please call 617-762-2334 to schedule an appointment.

Eligible staff and faculty and dependents on a Dana-Farber-employee health plan are each limited to one Galleri test during this pilot program.

The Galleri test is a screening test for asymptomatic adults with an elevated risk for cancer, such as those aged 50 or older. Galleri detects a signal shared by multiple cancers; when a Cancer Signal is Detected, Galleri predicts Cancer Signal Origin to guide diagnostic evaluation.

Every time you take the test, Galleri checks more than 100,000 DNA regions and over a million specific DNA sites to screen for a signal shared by multiple cancers. If a cancer signal is detected, results from the test can predict the tissue type or organ associated with the cancer signal. This information helps guide health care providers to perform a diagnostic evaluation for cancer.

The Galleri test looks for active cancer and does not predict future genetic risk for cancer.

Cancer risk increases for everyone as they age, regardless of family history—only 5% to 10% of cancers are inherited.

Age is the biggest risk factor for cancer. In fact, adults over age 50 are 13 times more likely to have cancer compared to people under the age of 50.

In a clinical study, Galleri detected a signal shared by over 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. 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.

Please note, if you are interested in requesting the Galleri test please be sure to return to this landing page and start the process at Galleri.com/dfci-pilot.

A “Cancer Signal Detected” result is expected in approximately 1% or 1 out of 100 Galleri tests in people over 50 years of age.

One of the ways we measure test accuracy is with Positive Predictive Value (PPV). PPV is the probability that a person with a “Cancer Signal Detected” test result truly has cancer.

In a recent clinical study, on average, 4 out of 10 people with a "Cancer Signal Detected" result received a cancer diagnosis with diagnostic testing, and 1 out of 200 people without cancer received a "Cancer Signal Detected" result.

(Positive Predictive Value was 43% and False Positive rate was 0.5%)

A False Positive is a test result that indicates that a person has a specific disease or condition when the person actually does not have the disease or condition.

No, Galleri is not a genetic risk assessment test. A genetic risk assessment is a one time only measurement and assesses your future risk of developing cancer. The Galleri test looks for a signal associated with active cancer at the time of your blood draw. Genetic tests may look at DNA and assess lifelong risk for cancer but cannot detect if a person currently has cancer.

Our goal is for Galleri to be a routine cancer screening test. By regularly using the Galleri test alongside recommended cancer screenings, you can increase your chance of finding cancer early.

No, the Galleri test is only commercially available in the US.

The Galleri test has not been cleared or approved by the FDA. Galleri is a Laboratory Developed Test. GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The GRAIL clinical laboratory also holds a New York Department of Health Clinical Laboratory Evaluation Program (CLEP) permit.

Eligible members and dependents who have had the test ordered for them by the independent telemedicine provider, have options to complete their blood draw.

Schedule an appointment at an upcoming blood draw event at Dana-Farber locations

OR

Alternatively, you can also visit Galleri.com/schedule to select your blood draw at either:

  • A GRAIL partner lab
  • A mobile phlebotomy option
    • A trained technician will come to your home, office, or any preferred location to complete your blood draw

Learn more about how your sample is processed at the GRAIL laboratory by watching this video.

Please note, if you are interested in requesting the Galleri test please be sure to return to this landing page and start the process at Galleri.com/dfci-pilot.

Once you receive your sample collection kit, please do not break the quality seal on it. The collection kit should be opened by the trained technician who draws your blood sample.

Store the kit at room temperature until your blood draw appointment. The contents are sensitive to extreme temperatures. For example, do not store the collection kit in a car.

To schedule your blood draw visit: Galleri.com/schedule

For the onsite blood draw events, please bring your Harvard Pilgrim Health Plan Member ID card. If your test request was approved and ordered, the onsite staff will have your collection kit.

For non-event telemedicine orders, please bring your unopened Galleri specimen collection kit and your completed and printed “Test Requisition Form” from the Telemedicine provider to your blood draw appointment.

You will receive these items if your eligibility for the Galleri test is approved.

  • A Galleri specimen collection kit will be mailed to you within one week after your request is approved. Do not break the quality seal on the specimen collection kit. It should be opened by the lab technician who draws your blood sample.
  • A completed Test Requisition Form will be emailed to you from the ordering telemedicine provider. Remember to print the form and bring it to your appointment.

The trained technician who draws your blood will pack and ship your sample back to the GRAIL laboratory for processing. Everything needed to complete the blood and return the sample is within the Galleri kit.

If you or your blood draw technician has questions, please call GRAIL Customer Service at (833) 694‑2553.

No fasting or preparation 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.

If you no longer wish to receive your Galleri results, please contact your ordering health care provider to request a cancellation. If you are not able to reach your health care provider or require further assistance, please contact GRAIL Customer Service by filling out a support request or calling 833−694−2553.

Please note, if your test has already been processed by GRAIL’s laboratory, you will be responsible for the cost of the test.

For test orders requested through Galleri.com/dfci-pilot, refunds can only be issued if requested within 30 days of ordering and your sample has not been received at the GRAIL laboratory.

Your sample will arrive at the GRAIL lab one to two business days after your blood draw. Test results will be available about two weeks after your sample is received at the GRAIL lab.

Your test results can be requested by contacting GRAIL Customer Service by filling out a support request or calling 833-694-2553.

The Galleri test detected a signal often associated with cancer. This result will also include one or two predictions of the tissue type or organ associated with the cancer signal, called ​“Cancer Signal Origin.”

Results should be interpreted by a health care provider. This test result is not a cancer diagnosis and requires follow-up diagnostic testing which may include lab work or imaging ordered by your health care provider to confirm cancer. GRAIL also offers patients and providers additional support and resources if needed to help guide next steps.

False positive results do occur.

The Galleri test looked for a cancer signal in your blood sample and did not find one. A Galleri result of No Cancer Signal Detected does not rule out cancer. The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood. Continue with routine cancer screenings your health care provider recommends. This result does not predict whether you will develop cancer in the future.

False negative results do occur.

The Galleri test is intended to be used in addition to, and not replace, other cancer screening tests your health care provider recommends. Single-cancer screening tests are recommended because they have been proven to save lives by detecting cancer early. Using Galleri in addition to recommended single-cancer screenings can increase your chances of finding cancer early, when there may be more treatment options.

Galleri 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 which may include lab work or imaging ordered by your health care provider to confirm cancer. GRAIL also offers patients and providers additional support and resources if needed to help guide next steps.

All results are automatically shared with the independent telemedicine provider who ordered the test.

If you would like GRAIL to fax your results to an additional health care provider, such as Dana-Farber’s Multi-Cancer Early Detection Clinic, please contact GRAIL Customer Service by calling 833−694−2553 to receive instructions on how to complete a results release form.

The health care 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. The ordering provider will help you understand your test results and determine your next steps.

Your test result and medical information are confidential. Access is limited to individuals who need the information for a specific purpose, such as the ordering telemedicine provider for either test request option in this pilot program – the onsite blood draw event or a telemedicine test request. 

The ordering telemedicine provider will help you understand your test results and determine your next steps.

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.

  1. Klein EA, Richards D, Cohn A, et al. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021;32(9):1167-77. DOI: https://doi.org/10.1016/j.annonc.2021.05.806.

  2. Schrag D, et al. Blood-based tests for multicancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023;402:1251-60. DOI: https://doi.org/10.1016/S0140-6736(23)01700-2.