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In the United States, cancer is the second leading cause of death, yet there are no recommended screenings for around 70 percent of cancers.*

Health systems could reverse this trend with multi-cancer early detection tests.

Discover how in this case study, which highlights how the Galleri® test empowers primary care providers to:

• Revolutionize cancer screening with multi-cancer early detection tests [1]
• Screen for over 50 cancers early with a single blood test [1]
• Predict a cancer signal origin with high accuracy to guide next steps to diagnosis [1,2]**

Screen for cancer when it is more treatable. Start reading now!

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. Galleri should be used in addition to healthcare provider recommended screening tests. For Important Safety Information, visit https://www.galleri.com/safety-information.

[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):1167-1177. Doi: 10.1016/j.annonc.2021.05.806. https://www.annalsofoncology.org/article/S0923-7534(21)02046-9/fulltext

[2] Schrag D, McDonnall CH, Naduld L, et al. PATHFINDER: A Prospective Study of a Multi-Cancer Early Detection Blood Test. Ann Oncol. 2022;33(suppl_7; abstr 9030). 10.1016/annonc/annonc1061 Presentation at European Society of Medical Oncology (ESMO) Congress September 9 – 13, 2022; Paris, France.

*Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) SEER*Stat Database Incidence — SEER Research Limited-Field Data, 21 Registries, Nov 2020 Sub (2000−2018) — Linked To County Attributes ‑Time Dependent (1990−2018) Income/Rurality, 1969 – 2019 Counties, National Cancer Institute, DCCPS, Surveillance Research Program, released April 2021, based on the November 2020 submission.

**In the PATHFINDER study, Cancer Signal Origin (CSO) prediction accuracy was 88% for participants with a cancer diagnosis among study participants with "Cancer Signal Detected" test result.

Important Safety 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.

Laboratory / Test Information
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.

© 2023 GRAIL

Vendor:

Grail

Posted:

Mar 14, 2023

Published:

Mar 14, 2023

Format:

PDF

Type:

White Paper