On April 22, 2025 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported that it 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) (Free AACR Whitepaper) Annual Meeting in Chicago, April 25-30, 2025 (Press release, Grail, APR 22, 2025, View Source [SID1234652022]).
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"GRAIL has an extensive evidence program that is setting the standard for multi-cancer early detection development that includes a large real-world dataset demonstrating Galleri test performance and implementation," said Josh Ofman, MD, MSHS, President of GRAIL. "The real-world findings being presented at AACR (Free AACR Whitepaper) support those observed in our previous clinical studies, highlighting the test’s ability to screen for deadly cancers that do not have recommended screening tests. Additional data presented will underscore the potential of GRAIL’s ctDNA-based targeted methylation assay for quantifying abnormal promoter methylation, which is a known hallmark of cancer and has shown potential utility as a biomarker in precision oncology."
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
The latest data from a real-world study of more than 100,000 participants with the Galleri test, consistent with previously reported large-scale clinical data, affirming the MCED test can reliably detect a cancer signal across a wide range of cancer types, including cancers without recommended screening, with a high Cancer Signal of Origin prediction accuracy to help guide diagnostic evaluations.
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
This modeling analysis shows that individuals receiving a no cancer signal detected MCED test result have a reduced risk of cancer diagnosis for one year post-blood draw; this risk increases as screening interval goes beyond one year, highlighting the importance of annual screening with the MCED test.
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
Leveraging insights from the Circulating Cell-free Genome Atlas (CCGA) study, this early proof-of-concept study underscores the potential of GRAIL’s ctDNA-based targeted methylation assay for detecting clinically informative promoter methylation signals in a plasma sample.
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
Based on this proof-of-concept study, GRAIL’s ctDNA-based targeted methylation assay enables subtyping across cancers using a single blood draw, without the need for invasive tissue biopsy.