Perspectives on clinical adoption barriers to blood-based multi-cancer early detection tests across stakeholders.

Abstract

e13574 Background: Current United States Preventive Services Task Force (USPSTF) recommendations include routine screening for breast, cervical, colorectal, and lung cancer; however, two out of every three cancer cases occur in other indications leading to diagnosis in advanced stages of the disease and higher likelihood of mortality. Current recommended cancer screening and early detection tests also face several hurdles hindering equitable access in a real-world setting. Blood-based MCED tests can impact cancer screening and early detection by monitoring for multiple different cancer types at once via a blood draw that can detect cancers in multiple indications, including indications where screening is not performed routinely today. Given their nascency, the role of blood-based MCED tests in clinical practice is currently undefined. To help facilitate the appropriate integration of MCED tests into patient care, it is important to understand the perspectives of stakeholders on the anticipated challenges to implementation. Methods: We conducted three separate double-blinded surveys in July 2023 of representative cohorts of U.S. Healthcare providers (HCPs) (n=238) that are or act as primary care providers (general practitioners and obstetrics and gynecologists (OB-GYNs)), payers (n=40), and patients (n=116), to evaluate the current cancer screening and early detection landscape and gather perspectives on barriers to implementation of new cancer screening technologies, including blood-based MCED tests. Results: Of the surveyed HCPs and payers, >90% and 100% respectively reported to be aware of MCED tests. However, <10% of HCPs reported having ordered an MCED test and 80% of payers had not yet evaluated an MCED test for coverage under their plan at the time of the survey. The survey results indicated that there is broad agreement on the value proposition that blood-based MCED tests would improve patient outcomes with earlier intervention. Despite this recognition, the survey highlighted that there is limited use today due to the perceived lack of clinical accuracy and utility data, high out-of-pocket patient costs, and lack of payer coverage. Conclusions: To overcome the hurdles for future widespread adoption of blood-based MCED tests, increased investment in data generation, education, and implementation of logistical support for HCPs will be critical. Initiatives include collaborations between stakeholders to generate near-term clinical utility data, equipping HCPs with the ability to educate patients on test accuracy, and seamlessly integrating the testing process into the patient visit workflow. The findings of this study can help build understanding of the anticipated barriers and inform strategies to alleviate them and build a foundation for clinical adoption of blood-based MCED tests.