GRAIL, Inc. recently published findings in JCO Precision Oncology highlighting the performance of its Galleri® multi-cancer early detection (MCED) test in prostate cancer. The study shows that Galleri effectively screens for aggressive prostate cancers while minimizing the risk of overdiagnosis of indolent, slow-growing cases. The data, drawn from the Circulating Cell-free Genome Atlas (CCGA) and PATHFINDER studies, included 420 prostate cancer patients. Results demonstrated that 93% of detected cases were intermediate or high-grade cancers, with 67% at stage III or IV. The cancer signal origin (CSO) prediction accuracy for prostate cancer was over 90%.
The test's sensitivity for early-stage prostate cancers (stages I and II) was 4.2%, reflecting the low shedding tumor fraction typical in these stages. Importantly, the Galleri test did not detect any low-grade cancers and identified only a small percentage of intermediate-grade and early-stage cancers. These findings suggest that the Galleri test can identify biologically significant prostate cancers that require treatment without exacerbating the problem of overdiagnosis.
Dr. Brandon Mahal, lead author and radiation oncologist at Sylvester Comprehensive Cancer Center, emphasized that these results demonstrate the potential of MCED tests like Galleri in population-based screening programs. Dr. Eric Klein, Distinguished Scientist at GRAIL, highlighted the high accuracy of the CSO prediction, underscoring the need for prompt diagnostic evaluation when a prostate cancer signal is detected. These findings affirm Galleri’s utility in enhancing prostate cancer screening while mitigating unnecessary treatment.