FAQs

for Providers about the Galleri® test


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Galleri is a screening test that analyzes methylation patterns on cell-free DNA to look for a unique cancer signature.1 All cells, including cancer growing in the body, shed DNA into the bloodstream, known as cell-free DNA (cfDNA). The Galleri test checks hundreds of thousands of methylation sites covering the most relevant genomic regions in DNA.2

When the Galleri test detects what could be cfDNA from cancer, it analyzes the methylation patterns to identify the tissue type or organ associated with the cancer signal. Based on this, Galleri indicates the most likely Cancer Signal Origin that can help guide the diagnostic workup to confirm the presence of cancer.1,3

Learn more about How Galleri Works.

In clinical studies, the Galleri test was able to detect a signal shared by more than 50 cancer types.1 This includes many of the deadliest cancers that currently lack screening options.4

The Galleri test comprises a two-step process: 

  1. The test detects a cancer signal by analyzing methylation patterns in cell-free DNA (cfDNA), which are DNA fragments circulating in the blood.
  2. The test predicts the tissue or organ associated with the cancer signal, also known as the Cancer Signal Origin (CSO).

When a cancer signal is detected, the Galleri test applies pattern recognition to compare the DNA methylation pattern in the patients’ cfDNA to the patterns of 18 possible CSO predictions.2 The overall accuracy for CSO prediction is 93.4%.2 In addition, some cancers have other patterns associated with biological information. This Additional Prediction Information may be present in 40% of Cancer Signal Detected results and is 93% accurate.2

The Galleri test analyzes cell-free DNA (DNA fragments circulating in the blood) to detect abnormalities in methylation patterns that could signal the presence of cancer.1 While the Galleri test is a powerful tool, it cannot detect all cancers. Some cancers shed little or no DNA into the bloodstream, which makes them unlikely to be detected through a blood test, for example brain, skin, and early breast and prostate cancers.5 

Galleri has higher sensitivity for the deadliest cancers, which helps minimize overdiagnosis and overtreatment of indolent cancers.  More aggressive cancers, such as pancreatic and ovarian* cancer, tend to release more cell-free DNA into the bloodstream at early stages and are more likely to be detected.1,6 The Galleri test demonstrated 76.3% sensitivity across all stages in cancers responsible for two-thirds of cancer deaths.† For these deadly cancers, 53% were detected at stages I-II, and 68% were detected at stages I-III.1

More cancers are detected early by adding the Galleri test. In PATHFINDER 2, the largest interventional MCED study conducted in the US,7>7 times as many cancers were detected when the Galleri test was added to standard-of-care screening with a USPSTF A and B rating.8‡§ More than half (54%) of the new ¶ cancers diagnosed after MCED testing were stages I and II.8 

Learn more about Galleri Test Performance.


*Sensitivity in study participants with pancreatic cancer: 83.7% overall (61.9% stage for I, 60.0% stage II, 85.7% stage III, 95.9% stage IV); and ovarian cancer: 83.1% overall (50.0% for stage I, 80.0% stage II, 87.1% stage III, 94.7% stage IV).

 †Anus, bladder, colon/rectum, esophagus, head and neck, liver/bile duct, lung, lymphoma, ovary, pancreas, plasma cell neoplasm, and stomach.

‡ USPSTF A and B rating, based on the first ~25,000 participants with 1 year of follow-up. 

§3 times as many cancers were detected when the Galleri test was added to USPSTF screenings A,B & C.

¶ New primary cancers

False positives occur with any type of cancer screening, such as mammography or stool-based colon screening. A low false positive rate — which may help minimize unnecessary diagnostic procedures, exposure to radiation, and patient anxiety — is a key component to a successful broad-based population cancer screening test.9 The Galleri test has a low false positive rate of 0.4%8 This means that in approximately 250 people without cancer, 1 person would be expected to receive a false positive result from the test. 

Learn more about Galleri Test Performance.

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.

Currently, single-cancer screenings play an important role in detecting 5 specific cancers—breast, cervical, colorectal, lung (for those at risk), and prostate—and have been shown to decrease cancer-specific mortality for the individual cancers that they detect.10 However, nearly 70% of cancer-related deaths are caused by cancers that don’t have recommended screenings.4,11* The Galleri test can screen for many of the deadliest cancers that do not currently have recommended screening, including pancreatic, ovarian, liver/bile duct, and others.1,4,6*

Learn more about Galleri Test Performance.

*Assumes screening is available for all prostate, breast, cervical, and colorectal cancer cases and 43% of lung cancer cases (based on the estimated proportion of lung cancers that occur in screen-eligible individuals older than 40 years). Sensitivity in study participants with — Pancreatic cancer: 83.7% overall (61.9% for stage I, 60.0% stage II, 85.7% stage III, 95.9% stage IV); ovarian cancer: 83.1% overall (50.0% for stage I, 80.0% stage II, 87.1% stage III, 94.7% stage IV); and liver/bile duct cancer: 93.5% overall (100% for stage I, 70.0% stage II, 100% stage III, 100% stage IV).

Cancer can impact anyone —about 90%-95% of cancers are not hereditary.12 The Galleri test identifies DNA shed by cancer cells into the bloodstream to screen for the current presence of cancer and can be done as an annual test. Germline genetic tests look for inherited mutations that increase the risk of developing cancer in the future and are usually done only once.1,13-16

The Galleri test must be ordered by a licensed healthcare provider with prescriptive authority in the state in which they will be prescribing the test. This may include physicians, nurse practitioners, or physician assistants.

The Galleri test is currently not included in cancer screening guidelines.

Adding annual testing with Galleri to recommended cancer screenings offers an increased opportunity for early cancer detection.6

Real-world evidence supports the utility of annual screening with the Galleri test. When comparing two cohorts of patients — one taking an annual Galleri test and the other having a single Galleri test — the results indicated that annual testing may improve the chance for early detection of multiple cancer types.17

The Galleri test is commercially available throughout the United States and in select geographic locations through distributors.

The list price for the Galleri test is $949. Your patients can receive a $799 self-pay test price ($150 off list price) when you select Bill to Patient (Self-pay) on the Galleri test requisition form. Blood draw services are included in the price of the test when a Galleri-contracted lab is used. Additional pricing options may be available to your practice - contact GRAIL Customer Service at 833−694−2553 or fill out a support request for more information.

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. 

The Galleri test is now covered for eligible beneficiaries through TRICARE. Prior authorization is required. Click here for more details.

GRAIL offers patients convenient payment options for the Galleri test. Patients may contact GRAIL Customer Service at (833) 694‑2553 to learn more about enrolling in a flexible payment plan.

For a patient paying directly for the test in full (patient self-pay), credit card information can be added to the paper Test Requisition Form at the time of order.

Patients can also pay for the test online with all major credit cards (American Express, Visa, Mastercard, and Discover) once their test has been processed by the GRAIL lab. Additionally, payment can be made over the phone by calling GRAIL Billing Support at 858-333-5986 or by mailing a physical check, GRAIL ID and bottom portion of invoice to GRAIL, Inc. at the address provided below

GRAIL, Inc.
Dept LA 25195
Pasadena, CA 91185 – 5195

Patients may be able to use pre-tax dollars in a flexible spending account (FSA) or health savings account (HSA) to pay for the Galleri test and should check with their FSA/HSA account administrator or insurance company to determine eligibility.

All or a portion of the Galleri test may be covered by some individual employers as an employer-sponsored benefit or by some life insurance providers as a covered benefit. Patients should contact their employer or life insurance administrator to learn whether they cover the Galleri test and to check their availability.

For electronic orders via the Provider Portal, patients will be invoiced via email and/or mail at the address(es) provided on the Test Requisition Form once the sample is received in the laboratory.

Patients should check with their FSA/HSA account administrator or insurance company to determine eligibility.

Below is information about the Galleri test and the GRAIL laboratory that you may find helpful for filling out a prior authorization form:

  • Test name: Galleri
  • Procedure or CPT code: 81479 (unlisted molecular pathology procedure)
  • Diagnosis Code: Discretion of provider
  • Lab: GRAIL, Inc.
  • NPI: 1053089425
  • Tax ID: 86-3673636
  • Address: 4001 E NC Hwy 54 Assembly Suite 1100, Durham, NC 27713
  • Phone: 833-694-2553
  • CLIA #: 34D2231294

Diagnosis codes may be required to bill the Galleri test to insurance and submit prior authorizations. Diagnosis code selection is determined at the discretion of the ordering provider. The below ranges reflect frequently observed codes and are not exhaustive of all options providers may choose for their patients: 

  • Z00–Z13 codes: Persons encountering health services for examinations
  • Z12–Z12.9 codes: Encounter for screening for malignant neoplasms (cancer)
  • Z77–Z92 codes: Individual risk factors, exposures, and medical history 

Additional codes and resources can be found on the CMS website.

If you are a returning provider, sign in to the Provider Portal to order the Galleri test.
If you are a new provider, please visit the Order Test page to start ordering the Galleri test.

Specimen requirements include:

  1. Specimen type: Whole blood
  2. Specimen receptacle: Streck Cell-Free DNA® blood collection tubes (included in the specimen collection kit)
  3. Volume: 10mL x 2 tubes
  4. Storage: Ambient temperature — not to extend outside the 1-40℃ (33.8-104℉) range. Do not refrigerate or freeze the kits before or after blood collection.
  5. Use by date: Blood can be drawn up to the use by date of the kit (if blood is collected after the use by date, the specimen cannot be processed and a re-draw will be required)
  6. Stability: Up to 7 calendar days (after 7 calendar days, the specimen cannot be processed and a re-draw will be required)

Specimen rejection criteria include:

  1. Tubes other than the Streck Cell-Free DNA blood collection tubes
  2. Less than 3mL of whole blood per collection tube
  3. Unlabeled specimens
  4. Severely damaged or dangerously packaged specimens (e.g., including the needle used for the blood draw)
  5. Specimens with grossly hemolyzed whole blood
  6. Collection date more than 7 days prior to the sample being received at the GRAIL laboratory.

Collection kits should be stored at room temperature. Avoid storing them in places that experience high or low temperatures, like window sills or near central heating vents.

Also, leave the box unopened and sealed; only the phlebotomist should open the kit at the time of the blood draw.

No, the Galleri test blood draw requires no preparation or fasting by the patient. Fasting for other blood draws will not affect the Galleri test results if blood is drawn at the same time.

Test results should be available to the ordering provider about 2 weeks after your patient’s sample arrives at the GRAIL lab. In certain cases, results may take up to 4 weeks. Typically, a sample arrives at the laboratory in 1 to 2 business days after the blood sample is shipped.

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

In the rare scenarios when a sample fails, you will be notified about your patient’s sample status.

The Galleri test results are shared with the ordering healthcare provider via the online Provider Portal and/or via automatic fax notifications. An email notification will be sent to the ordering provider when new test result reports are ready in the Provider Portal. Your patient will also be notified via email when their results are ready.

If you or a patient would like to cancel a test order, contact GRAIL Customer Service at (833) 694‑2553 or fill out a support request.

A No Cancer Signal Detected result indicates that the Galleri test did not detect a methylation pattern associated with cancer. In the PATHFINDER 2 clinical study, on average, fewer than 1 out of 100 people with a No Cancer Signal Detected result received a cancer diagnosis (the negative predictive value or NPV was 99.1%).8

The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood. A No Cancer Signal Detected result does not completely rule out the possibility of cancer and does not predict the risk of developing cancer in the future. Individuals who receive a No Cancer Signal Detected result should continue with all recommended cancer screening options at intervals appropriate for the individual.

A Cancer Signal Detected result indicates that the Galleri test detected cfDNA with methylation patterns often associated with cancer. In the PATHFINDER 2 study, about 6 out of 10 people with a Cancer Signal Detected result received a cancer diagnosis (the positive predictive value or PPV was 61.6%).8

Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer.

If a cancer signal is detected, the Galleri test predicts the most likely tissue type or organ associated with the cancer signal to help guide the next steps to diagnosis.1 The CSO prediction is provided to help guide the diagnostic evaluation needed to confirm the presence of cancer and the cancer type.

Diagnostic tests needed to confirm a cancer diagnosis may vary depending on the reported Cancer Signal Origin and should be chosen in accordance with standard medical practice.6 Diagnostic decisions are the responsibility of the treating physician. GRAIL also offers clinical support and resources to help ensure you and your patients are supported after a Cancer Signal Detected result.

For more information about our clinical support resources, contact GRAIL Customer Service at (833) 694‑2553 or fill out a support request.

In the event that a diagnostic evaluation after a Cancer Signal Detected result does not confirm cancer, patients may be eligible for a complimentary Galleri retest within 3 to 6 months after the original test result. To initiate a no-charge retest or obtain more information on our clinical support resources, contact GRAIL Customer Service at (833) 694‑2553 or fill out a support request.

A test may be canceled for various reasons, including the following:

  • Cancellation request of the provider or patient
  • Exceeding the specimen stability window
  • Failure to meet the sample quality requirements

For more information on your specific cancellation, contact GRAIL Customer Service at (833) 694‑2553 or fill out a support request.

Galleri test results can be accessed via the Provider Portal.

For more information about a specific patient’s test result, contact GRAIL Customer Service at  (833) 694‑2553 or fill out a support request.

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.

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

  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 Sep;32(9):1167-77. doi: 10.1016/j.annonc.2021.05.806
  2. GRAIL, Inc. Enhanced Cancer Signal Origin prediction. [Data on file: VV-TMF-59592]
  3. Thierry AR, El Messaoudi S, Gahan PB, et al. Origins, structures, and functions of circulating DNA in oncology. Cancer Metastasis Rev. 2016 Jul 8;35:347–76. doi: 10.1007/s10555-016-9629-x
  4. US Preventive Services Task Force. A,B,C grade recommendations, cancer, screening [cited 2025 Mar 18]. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results?category%5B%5D=15&searchterm=
  5. Bredno J, Venn O, Chen X, et al. Circulating tumor DNA allele fraction: a candidate biological signal for multicancer early detection tests to assess the clinical significance of cancers. Am J Pathol. 2022;192(10):1368-78. doi: 10.1016/j.ajpath.2022.07.007
  6. Schrag D, Beer TM, McDonnell CH, et al. Blood-based tests for multicancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023;402(10409):1251-60. doi: 10.1016/S0140-6736(23)01700-2
  7. GRAIL, Inc. Demonstrated performance in individuals screened for cancer. [Data on file: GA-2025-0257]
  8. Nabavizadeh N, et al. Safety and performance of a multi-cancer early detection (MCED) test in an intended-use population: initial results from the registrational PATHFINDER 2 study [proffered presentation]. European Society for Medical Oncology (ESMO) Congress; 2025 Oct 17-21; Berlin.
  9. Bolejko A, et al. Cancer Epidemiol Biomarkers Prev. 2015 Sep;24(9):1388-97. 
  10. American Cancer Society. Cancer facts & figures 2025. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2025-cancer-facts-figures.html  
  11. Hackshaw A, et al. Cancer Cell. 2022;40(2):109-13. GRAIL, Inc. Demonstrated performance in individuals screened for cancer. [Data on file: GA-2025-0257]
  12. NIH, National Cancer Institute. Genetic testing for inherited cancer risk [cited 2025 Jun 24]. https://www.cancer.gov/about-cancer/causes-prevention/genetics/genetic-testing-fact-sheet
  13. American Cancer Society. Understanding genetic testing for cancer risk [cited 2024 Mar 15] https://www.cancer.org/cancer/risk-prevention/genetics/genetic-testing-for-cancer-risk/understanding-genetic-testing-for-ca ncer.html
  14. Patel A. Methylated DNA biomarkers and incident cancer in the American Cancer Society (ACS) Cancer Prevention Study-3 (CPS-3) cohort. American Society of Clinical Oncology (ASCO) Virtual Annual Meeting [presentation]; 2023 Jun 2-6. https://meetings.asco.org/abstracts-presentations/218486
  15. Sasieni P, Clarke CA, Hubbell E. Impact of MCED screening interval on reduction in late-stage cancer diagnosis and mortality. European Society for Medical Oncology (ESMO) Virtual Congress [poster]; 2021 Sep 16-21.
  16. Schwartzberg L, Broder MS, Ailawadhi S, et al. Impact of early detection on cancer curability: A modified Delphi panel study. PLoS One. 2022;17(12):e0279227. doi: 10.1371/journal.pone.0279227
  17. Abrams R, Shaknovich R, Lipton J, et al. Early real-world experience with repeat multi-cancer early detection (MCED) testing [presentation]. American Association for Cancer Research (AACR) Annual Meeting; 2024 Apr 5-10; San Diego. https://grail.com/wp-content/uploads/2024/04/Abrams_AACR-2024_Repeat-Testing_Oral-Presentation_Final.pdf