GRAIL, Inc. (Nasdaq: GRAL) will present significant new data on its Galleri® multi-cancer early detection (MCED) test at the upcoming American Association for Cancer Research (AACR) Annual Meeting in Chicago, April 25-30, 2025. The presentations will feature real-world evidence from over 100,000 patients and new findings from the company's circulating tumor DNA (ctDNA)-based targeted methylation platform.
"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 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."
Real-World Performance Data Validates Clinical Utility
The largest dataset of its kind to date, comprising more than 100,000 individuals who underwent Galleri testing, confirms the test's ability to reliably detect cancer signals across a wide range of tumor types. Importantly, these findings align with previous clinical trial results and demonstrate high accuracy in predicting the cancer signal origin (CSO), which is crucial for guiding efficient diagnostic evaluations.
The Galleri test is particularly valuable for detecting cancers without existing screening recommendations. Previous studies have shown impressive sensitivity rates for hard-to-detect cancers, including pancreatic (83.7% overall), esophageal (85.0% overall), ovarian (83.1% overall), and liver/bile duct cancers (93.5% overall).
Cancer Risk Modeling Supports Annual Screening Recommendation
A complementary modeling analysis being presented at AACR estimates the short- and long-term cancer risk following a negative Galleri test result. The data indicate that individuals receiving a "no cancer signal detected" result have a significantly reduced risk of cancer diagnosis within one year of testing.
However, the analysis also reveals that cancer risk gradually increases when screening intervals extend beyond one year, providing strong evidence for GRAIL's recommendation of annual testing among eligible individuals.
Advances in Methylation-Based Cancer Detection
Beyond the Galleri test performance data, GRAIL will present two early-stage research abstracts focused on its ctDNA-based targeted methylation assay. These studies highlight the potential of the technology for broader applications in cancer detection and classification.
The first proof-of-concept study, drawing from the Circulating Cell-free Genome Atlas (CCGA), evaluates the potential of plasma-derived ctDNA in detecting abnormal promoter methylation—a known molecular hallmark of malignancy. The data support the potential of GRAIL's assay to utilize methylation signatures as clinically actionable biomarkers for screening and precision oncology applications.
A second study demonstrates that GRAIL's assay can detect and differentiate cancer subtypes across various malignancies using a single blood draw. This capability has significant implications for avoiding invasive tissue biopsies and may inform tumor classification strategies in future clinical workflows.
The Technology Behind Galleri
The Galleri test analyzes cell-free DNA fragments in blood to detect abnormal methylation patterns associated with more than 50 types of cancer. The foundation of this liquid biopsy approach is the principle that mutant plasma DNA templates originate from dying cancer cells and offer highly specific markers for identifying neoplasia.
"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," Dr. Ofman added.
Clinical Implementation Guidelines
The Galleri test is currently intended for use in individuals aged 50 or older or those at elevated cancer risk. It requires a prescription from a licensed healthcare provider and should be used alongside guideline-recommended screenings such as mammography, colonoscopy, prostate-specific antigen testing, or cervical cancer screening.
GRAIL emphasizes that the test is not recommended for individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment. A "No Cancer Signal Detected" result does not rule out cancer, and a "Cancer Signal Detected" result requires confirmatory diagnostic evaluation through established medical procedures such as imaging.
Future Implications
The comprehensive data being presented at AACR 2025 reinforces GRAIL's position at the forefront of multi-cancer early detection technology. By combining next-generation sequencing, population-scale clinical studies, and advanced machine learning, the company continues to advance its mission of detecting cancer early, when it can be cured.
As the evidence base for the Galleri test grows, healthcare providers and policymakers will have more robust data to inform decisions about incorporating multi-cancer early detection into routine clinical practice, potentially transforming cancer screening paradigms and improving outcomes for patients worldwide.
