Implementation of a Multicancer Detection (MCD) Test in a Tertiary Referral Center in Asymptomatic Patients: An 18-Month Prospective Cohort Study
Ryan T. Hurt, Aditya Ghosh, Brian M. Dougan, Elizabeth A. Gilman, Bradley R. Salonen, Jayanth Adusumalli, Sara L. Bonnes, Carl Andersen, Amirala S. Pasha, S. Nanda, Erin M. Pagel, Christina D. Verness, Steven D. Crowley, Steven W. Ressler, Jewel Samadder, R. John Presutti, Aadel A. Chaudhuri, William Sánchez, Ivana T. Croghan, Christopher R. Stephenson, Karthik Ghosh
Abstract
OBJECTIVE: Multicancer Detection (MCD) tests, such as the GRAIL Galleri, offer a novel approach to cancer screening by detecting cancer-specific methylation patterns in cell-free DNA through a single blood sample. This study evaluated an 18-month implementation of MCD testing in a tertiary ambulatory internal medicine clinic. PATIENTS AND METHODS: Between June 2022 and November 2023, 2244 asymptomatic (without symptoms attributed to cancer) patients underwent MCD testing. The study focused on operational workflows, patient and physician education, and diagnostic follow-up of positive results. Standardized materials, including electronic health record (EHR) workflows, FAQs, and diagnostic pathways, were developed to facilitate implementation. Challenges included managing false positives, patient anxiety, costs, and ethical considerations. RESULTS: Of the 2244 patients tested, 17 (0.76%) had positive results, and 15 underwent further diagnostic evaluation. Cancer was confirmed in 11 (73.3%) patients, including cases of breast, colon, esophageal, lymphoma, ovarian, and pancreatic cancers. Four patients had no identifiable malignancy despite comprehensive work-up. CONCLUSIONS: MCD testing is feasible in routine clinical workflows, with 73% of positive cases yielding cancer diagnoses. While promising, further research is required to assess long-term outcomes, cost-effectiveness, and optimal implementation strategies of cancer interception in broader healthcare settings.