FDA Submission Marks a Pivotal Milestone in Advancing Early Cancer Detection, Addressing Unmet Needs in Cancer Screening
GRAIL, a healthcare company focused on identifying cancer at its earliest and most treatable stages, announced that it has submitted the final section of its Premarket Approval application to the U.S. Food and Drug Administration for the Galleri multi cancer early detection blood test. The Galleri test, which was granted Breakthrough Device designation by the FDA in 2018, is designed to screen for multiple cancers through a single blood draw, many of which currently lack routine screening options.
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According to Josh Ofman, MD, MSHS, President of GRAIL, cancer has become the leading cause of death among adults over the age of 50 in the United States, largely because many aggressive cancers are diagnosed at advanced stages when treatment options are limited and outcomes are poorer. He emphasized that current screening approaches leave major gaps and that continuing with existing methods alone is not sufficient. Dr. Ofman explained that incorporating Galleri alongside established single cancer screening tests could significantly strengthen national screening efforts by identifying cancers earlier, when intervention may be more effective. He noted that the test has undergone extensive evaluation across multiple study designs and stated that the FDA submission represents an important milestone toward broader access and meaningful public health impact.
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The PMA application is primarily supported by clinical performance and safety data from the PATHFINDER 2 study, which included 25,490 consented participants in the United States with one year of follow up. Additional evidence comes from the first year of screening in the NHS Galleri trial, which is the largest randomized controlled study conducted to date for any multi cancer early detection test in an intended screening population. The submission also includes a bridging analysis demonstrating comparable performance between earlier versions of the Galleri test used in these trials and the updated version submitted for FDA review.
The NHS Galleri trial, is the first prospective randomized controlled study designed to evaluate the clinical utility of a multi cancer early detection test when used alongside standard care in a population screening setting. Conducted in collaboration with the National Health Service in England, the trial enrolled more than 140,000 asymptomatic adults between the ages of 50 and 77. Participants provided three blood samples over a two year period. The primary goal of the study is to demonstrate a reduction in late stage cancers among individuals who received the Galleri test compared with those who did not. This analysis focuses initially on a predefined group of 12 cancer types that together account for roughly two thirds of cancer related deaths in both England and the United States. Secondary goals include evaluating reductions in stage IV cancers, assessing test accuracy metrics such as positive predictive value and false positive rate, measuring cancer detection rates, monitoring safety, and analyzing healthcare resource use.
PATHFINDER 2, is a prospective multi center interventional study assessing the safety and performance of the Galleri test in approximately 35,000 adults aged 50 and older across the United States who are eligible for guideline recommended cancer screening. The study aims to measure the number and type of diagnostic procedures required following a cancer signal detected result and to evaluate test performance across multiple indicators, including sensitivity, specificity, positive and negative predictive values, and cancer signal origin prediction accuracy. Participants who receive a positive signal undergo additional diagnostic evaluations guided by the predicted cancer origin to confirm the presence of disease. Secondary objectives include examining how use of the test influences adherence to recommended screening practices and assessing participant reported outcomes such as anxiety levels and satisfaction over time.
Together, these studies form the foundation of GRAIL’s FDA submission and reflect a broader effort to change how cancer is detected, with the goal of shifting diagnosis to earlier stages and improving outcomes for patients.
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