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GRAIL to Share Real-World Data from 100,000 Galleri Multi-Cancer Detection Tests at 2025 AACR Meeting
GRAIL announced plans to present new support for the Galleri test's ability to simultaneously screen for multiple cancers plus its accuracy for cancer signal of origin prediction.
GRAIL Inc announced it will present 4 new data sets that reinforce the clinical performance and research potential of its Galleri multi-cancer early detection (MCED) test and its underlying methylation-based platform at the 2025 American Association for Cancer Research (AACR) Annual Meeting in Chicago, April 25-30.
The presentations span real-world performance, cancer risk modeling, and early applications of ctDNA-based promoter methylation analysis for cancer subtyping, according to a company news release.1
Abstract #7202: Real-world data and clinical experience from over 100,000 multi-cancer early detection tests
In the largest dataset of its kind to date, according to GRAIL, the company will present real-world data from more than 100,000 individuals who underwent Galleri testing. The findings are consistent with prior clinical trials and show that the Galleri test can reliably detect a cancer signal across a wide range of tumor types, including those without existing screening recommendations. Importantly, the test demonstrated high accuracy in predicting the cancer signal origin (CSO), a key component in streamlining downstream diagnostic evaluations.
These findings will be shared on April 30 during the poster session Targeted Therapies and Combinations 4, from 9:00-12:00.
Abstract #7132: Estimated Post-Test Probabilities of Cancers For Individuals Receiving Multi-Cancer Early Detection (MCED) Tests
This modeling analysis estimates the short- and long-term cancer risk following a negative Galleri test result. The data suggest that individuals with a "no cancer signal detected" result had a significantly reduced risk of receiving a cancer diagnosis within one year of testing. However, cancer risk gradually increases when screening intervals extend beyond one year, supporting the rationale for annual testing among eligible individuals.
This poster will also be presented on April 30 during the session Immune Monitoring / Clinical Correlates, from 9:00-12:00.
In addition to real-world implementation data, GRAIL will present 2 early-stage research abstracts focused on its circulating tumor DNA (ctDNA)-based targeted methylation assay.
Abstract #1943: Promoter Methylation as a Cancer Biomarker: Insights From ctDNA-Based Targeted Methylation Data
The early proof-of-concept study draws from the Circulating Cell-free Genome Atlas (CCGA) study to evaluate the potential of plasma-derived ctDNA in detecting abnormal promoter methylation—a known molecular hallmark of malignancy. The data support the potential of the company's ctDNA-based targeted methylation assay to utilize methylation signatures as clinically actionable biomarkers for screening and precision oncology applications.
This study will be presented on April 28 during the session Liquid Biopsy: Circulating Nucleic Acids 5 / Circulating Tumor Cells 2, from 9:00-12:00.
Abstract #1947: Assessment of Cancer Subtypes Across Multiple Cancer Types Using a Circulating Tumor DNA (ctDNA)-Based Targeted Methylation Assay
Findings from this study demonstrate that GRAIL’s assay can detect and differentiate cancer subtypes across various malignancies using a single blood draw. This has potential implications for avoiding invasive tissue biopsy and may inform tumor classification strategies in future clinical workflows.
This poster is also slated for presentation April 28 during the same session noted above, from 9:00 to 12:00.1
Galleri MCED
The foundation of liquid biopsy is the principle that mutant plasma DNA templates originate from dying cancer cells and offer highly specific markers for identifying neoplasia. Typical molecular biomarkers that can provide insights into disease prognosis include RNA strands, DNA mutation, proteins, and protein fragments.2
The Galleri test analyzes cell-free DNA fragments in blood to detect abnormal methylation patterns associated with more than 50 types of cancer. It is currently intended for use in individuals aged 50 or older or those at elevated cancer risk, requires a prescription, and should be used alongside guideline-recommended screenings such as mammography, colonoscopy, prostate-specific antigen test, or cervical cancer screening, GRAIL stated. Prior clinical studies have shown promising sensitivity for hard-to-detect cancers, including pancreatic, esophageal, ovarian, and liver/bile duct cancers.1
Use of the Galleri test is not recommended in individuals who are pregnant, aged 21 years or younger, or undergoing active cancer treatment.
