Abstract
1526 Background: Cancer is the second leading cause of death globally. Currently, USPSTF recommends screening for only 5 (breast, cervical, colorectal, lung [high-risk], prostate [individualized basis]) cancers, but ~70% of cancer-related deaths are from cancers without recommended screening. Galleri (GRAIL, LLC, Menlo Park, CA), an MCED test, that uses a cell-free DNA-based targeted methylation assay and machine learning classifiers to detect a shared cancer signal and predict the cancer signal origin is available for use as a complement to existing screening tests. We present a model of centralized MCED test implementation w/i a multi-state health system. Methods: From 11/2021-7/2022, clinical and operational leadership w/i the Mercy Health System (headquartered in St. Louis, MO), including 44 acute and specialty hospitals with over 4000 integrated providers and 44000 coworkers in 5 states (MO, KS, AR, OK, IL), created an MCED test implementation plan for their health system. Results: A model with centralized navigation was developed such that patients (pts) and providers contacted a singular team (MCED team) w/i the Mercy Precision Medicine Division using telemedicine to order an MCED test and navigate processes. In the 2 months prior to and after launch (7/12/2022), 12 medical education sessions were held for various groups w/i the health system, including the centralized MCED team, leaders of subspeciality departments, and all primary care providers, to inform on the MCED test implementation plan. In this model, access to MCED testing commences in 2 ways: (1) pts register through an online form or (2) providers w/i the health system submit a referral to the MCED team through the electronic medical record system. Pts are then contacted by a nurse practitioner on the MCED team for pretest counseling w/i 2 business days. If the pt is still interested after counseling, an MCED test is ordered. Pts go to 1 of 11 Mercy labs to have their blood drawn for MCED testing. “Cancer signal detected (CSD)” test results are given to a specialized navigator who helps schedule diagnostic testing and initial appointments with specialists and coordinates follow-up care and treatment (tx) w/i the health system. Early analytics show that from launch to 1/31/2023, there were 3777 total referrals (2931 pt, 846 provider) that led to 925 MCED test orders, of which 6 had a CSD result. Median time from a CSD test result to pt notification was 22.8 hours, to initial diagnostic evaluation was 3.1 days, and to a cancer diagnosis was 8.7 days. Median time from cancer diagnosis to initiation of tx or first postdiagnosis specialist visit was 33 days. Conclusions: This model allowed for efficient time to diagnosis and tx or triage of eligible-risk pts using an MCED test and is an example of how a healthcare system can incorporate and scale the implementation of the MCED test into clinical practice.
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