OBJECTIVES: Earlier cancer detection has the potential to reduce morbidity and mortality. This analysis describes the outcomes of current U.S. guideline-recommended cancer screening and the potential impact of incorporating an investigational multi-cancer early detection (MCED) test, which detected >20 cancers in clinical trials, to current (single-cancer) screening paradigm.

METHODS: This analysis is based on the U.S. population aged 50-79 using nationally representative adherence rates to current cancer screening recommendations (BRFSS, 2018), which include breast, cervical, colorectal, and lung cancer (specificity ranging from 85-89%; sensitivity ranging from 85-95%), applying SEER cancer incidence. The impact of a MCED test with a specificity of 99.3% and overall sensitivity of 55% (Liu, 2019) was incorporated in addition to guideline-recommended screenings in the entire cohort to assess the potential incremental impact of the MCED test. Diagnostic costs associated with confirmed cancer diagnoses and false positive test results were estimated for commercial payers based on recommended clinical workups.

RESULTS: Projecting SEER cancer incidence and current screening recommendations to the U.S. population aged 50-79 (n=104,693,580) at adherence rates of 78.3%, 80.1%, 69.6%, and 3.9% for breast, cervical, colorectal, and lung cancer, respectively, approximately 9M positive screening tests would be generated with approximately 150K cancers detected — a true positive-to-false positive ratio of 1:60. Incorporating a MCED test to the population in addition to recommended screening has the potential to detect approximately 450K additional cancer cases, which otherwise would have been detected clinically at later stages, with an incremental true positive-to-false positive ratio of 1:2.3. Estimated diagnostic work-up costs for current screening recommendations alone are approximately $20.0B. Incremental diagnostic work-up costs associated with the addition of MCED testing are estimated at $3.6B.

CONCLUSIONS: Adding a multi-cancer early detection test to guideline-recommended screening has the potential to efficiently identify multiple cancer types while minimizing the risk of additional false positive results.