GRAIL Announces Positive Top-Line Results From The Galleri® PATHFINDER 2 Registrational Study
- Significantly improved cancer detection rates compared to previous PATHFINDER study
- Maintained high specificity of 99.5% and 88% cancer signal origin accuracy
- No serious safety concerns reported in the trial
- FDA Breakthrough Device Designation status for accelerated review
- Study results support upcoming FDA premarket approval application
- Complete PMA submission not expected until first half of 2026
- Detailed study results not yet publicly available
- Additional bridging analyses required to compare different versions of Galleri test
Insights
GRAIL's cancer detection test showed substantially improved performance in PATHFINDER 2 study, advancing toward FDA approval with breakthrough status.
GRAIL's Galleri multi-cancer early detection (MCED) test has demonstrated significantly improved performance in their PATHFINDER 2 registrational study involving 25,578 participants aged 50+ with no clinical suspicion of cancer. The test achieved a substantially higher positive predictive value (PPV) than in the previous PATHFINDER study, while maintaining consistent cancer signal origin (CSO) accuracy of around 88% and specificity of approximately 99.5%.
The clinical significance here is substantial. Adding Galleri to standard screening protocols more than doubled cancer detection rates in the previous study, and PATHFINDER 2 shows even greater additional detection capability. This represents a potential paradigm shift in cancer screening by addressing a critical gap - many cancers currently lack recommended screening protocols and are detected only after symptoms appear, often at advanced stages.
Importantly, GRAIL reported no serious safety concerns in this large population study, addressing a critical requirement for any widely deployed screening test. The company is leveraging these positive results for their premarket approval application (PMA) with the FDA, where Galleri already holds Breakthrough Device Designation. This regulatory pathway acknowledges the technology's potential significant advantages over existing alternatives.
The company expects to complete their modular PMA submission in H1 2026, with detailed PATHFINDER 2 results to be presented at an upcoming oncology conference. These results, combined with data from the NHS-Galleri trial, position GRAIL strongly in the emerging multi-cancer early detection field, where early detection can significantly improve treatment outcomes and survival rates.
Cancer Detection and Positive Predictive Value Substantially Higher Than the Previously Published PATHFINDER Study
In the previously published PATHFINDER study, adding Galleri to standard of care cancer screening more than doubled the overall number of cancers detected by screening. In PATHFINDER 2, adding Galleri to standard of care screening demonstrated substantially greater additional cancer detection than in PATHFINDER.
In PATHFINDER, Galleri demonstrated a positive predictive value (PPV), or likelihood that a positive Galleri test was confirmed to be cancer, of
There were no serious safety concerns reported in PATHFINDER 2.
"We are delighted to see very encouraging performance of the Galleri MCED test as a cancer screening tool in broad intended use populations of asymptomatic adults over 50 years of age in both the PATHFINDER 2 study and the NHS-Galleri trial's prevalent screening round," said Josh Ofman, MD, MSHS, President at GRAIL. "We would like to extend our sincere gratitude to all of the participants and investigators in both of these pivotal studies, who are collectively helping to realize the potential of this groundbreaking technology for population-scale multi-cancer early detection and move the field forward. We look forward to sharing the detailed PATHFINDER 2 data at a medical congress later this year."
PATHFINDER 2 study results will be submitted to the
Detailed results from the PATHFINDER 2 study will be submitted for presentation at a leading international oncology meeting before the end of the year.
About the PATHFINDER 2 Study (NCT05155605)
PATHFINDER 2 is a prospective, multi-center, interventional study evaluating the safety and performance of Galleri in approximately 35,000 individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in
About GRAIL
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages. GRAIL's targeted methylation-based platform can support the continuum of care for screening and precision oncology, including multi-cancer early detection in symptomatic patients, risk stratification, minimal residual disease detection, biomarker subtyping, treatment and recurrence monitoring. GRAIL is headquartered in
For more information, visit grail.com.
About Galleri®
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.
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, include the benefits and use of the Galleri test, the potential of the Galleri MCED test, upcoming events and presentations, the timeline for submission of PATHFINDER 2 study results and a bridging analyses to the FDA, and the timeline for completion of the PMA modular submission.
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-Q for the period ended March 31, 2025 and our 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.
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SOURCE GRAIL, Inc.
FAQ
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