Full Press Release Details
Real-World Data in 100,000 Patients Further Support the Galleri® Test's Ability to Simultaneously Screen for Multiple Cancers, as Well as its Accuracy of Cancer Signal of Origin Prediction to Support More Efficient Diagnostic Evaluations
Data From GRAIL's ctDNA-based Targeted Methylation Assay Highlight Potential to Identify Robust Signals of Promoter Methylation
MENLO PARK, Calif. , April 22, 2025 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL ), a healthcare company whose mission is to detect cancer early when it can be cured, will present new data highlighting the latest real-world evidence with the Galleri® multi-cancer early detection (MCED) test and additional data from GRAIL's circulating tumor DNA (ctDNA)-based targeted methylation platform at the American Association for Cancer Research (AACR) Annual Meeting in Chicago , April 25-30, 2025 .
Data Presentations
Title: Real-world data and clinical experience from over 100,000 multi-cancer early detection tests Abstract Number : 7202 Session Title: Targeted Therapies and Combinations 4 Date/Time : April 30, 2025 , 9 am-12 pm Location : Poster section 35
Title: Estimated Post-Test Probabilities of Cancers For Individuals Receiving Multi-Cancer Early Detection (MCED) Tests Abstract Number: 7132 Session Title: Immune Monitoring / Clinical Correlates Date/Time: April 30, 2025 , 9 am-12 pm Location: Poster section 31
Title: Promoter Methylation as a Cancer Biomarker: Insights From ctDNA-Based Targeted Methylation Data Abstract Number : 1943 Session Title: Liquid Biopsy: Circulating Nucleic Acids 5 / Circulating Tumor Cells 2 Date/Time : April 28, 2025, 9 am- 12 pm Location : Poster section 28
Title: Assessment of Cancer Subtypes Across Multiple Cancer Types Using a Circulating Tumor DNA (ctDNA)-Based Targeted Methylation Assay Abstract Number : 1947 Session Title: Liquid Biopsy: Circulating Nucleic Acids 5 / Circulating Tumor Cells 2 Date/Time : April 28, 2025 , 9 am-12 pm Location : Poster section 28
For more information, visit grail.com .
About the Galleri ® Test The Galleri multi-cancer early detection test is a proactive tool to screen for cancer. With a simple blood draw, the Galleri test can identify DNA shed by cancer cells, which can act as a unique "fingerprint" of cancer, to help screen for some of the deadliest cancers that don't have recommended screening today, such as pancreatic, esophageal, ovarian, liver, and others.* The Galleri test can be used to screen for cancer before a person becomes symptomatic, when cancer may be more easily treated and potentially curable. The Galleri test can indicate the origin of the cancer, giving healthcare providers a roadmap of where to explore further. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. The Galleri test is recommended for adults with an elevated risk for cancer, such as those aged 50 or older.
For more information, visit galleri.com .
Sensitivity in study participants with – Pancreas cancer: 83.7% overall (61.9% stage I, 60.0% stage II, 85.7% stage III, 95.9% stage IV). Esophagus cancer 85.0% overall (12.5% stage I, 64.7% stage II, 94.7% stage III, 100% stage IV). Ovary cancer: 83.1% overall (50.0% stage I, 80.0% stage II, 87.1% stage III, 94.7% stage IV). Liver/bile duct cancer: 93.5% overall (100% stage I, 70.0% stage II, 100% stage III, 100% stage IV).
Important Galleri Safety Information 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.
Laboratory/Test Information 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.
Forward-Looking Statements This press release contains forward-looking statements. In some cases, you can identify these statements by forward-looking words such as "aim," "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "should," "would," or "will," the negative of these terms, and other comparable terminology. These forward-looking statements, which are subject to risks, uncertainties, and assumptions about us, may include expectations about or projections of Galleri performance, Galleri clinical impact, proof of concept results that could support future products or product improvements, technology, clinical and real world studies, regulatory compliance, potential market opportunity, anticipated growth strategies, and other topics.
These statements are only predictions based on our current expectations and projections about future events and trends. There are important factors that could cause our actual results, level of activity, performance, or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements, including those factors and numerous associated risks discussed under the section entitled "Risk Factors" in our Annual Report on Form 10-K for the period ended December 31, 2024 (the "Form 10-K"). Moreover, we operate in a dynamic and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results, level of activity, performance, or achievements to differ materially and adversely from those contained in any forward-looking statements we may make.
Forward-looking statements relate to the future and, accordingly, are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Although we believe the expectations and projections expressed or implied by the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, we undertake no obligation to update any of these forward-looking statements after the date of this press release to conform our prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events.
SOURCE GRAIL, Inc.