Multicancer Early Detection: Learning From the Past to Meet the Future.

Area of Science:

• Oncology
• Medical Diagnostics
• Public Health

Background:

• Multicancer early detection (MCED) blood tests are emerging as a novel approach for cancer screening.
• Current understanding of MCED tests is limited, primarily focusing on diagnostic performance rather than broader clinical utility.

Purpose of the Study:

• To identify critical factors influencing the translation of MCED test performance into population health benefits.
• To highlight knowledge gaps preventing reliable projection of MCED tests' clinical impact.
• To inform stakeholders about the uncertainties surrounding MCED tests' effects on health outcomes.

Main Methods:

• Analysis of historical cancer early detection strategies.
• Identification and examination of three key factors: cancer signal confirmation, population testing strategy, and cancer natural history.
• Literature review and synthesis of existing knowledge on these factors in the context of MCED testing.

Main Results:

• The ability to confirm a cancer signal, the population testing strategy employed, and the natural histories of the targeted cancers are crucial for determining MCED test benefit-harm trade-offs.
• Significant knowledge gaps exist for each of these factors, hindering accurate prediction of MCED tests' clinical impact.
• The overall uncertainty regarding MCED tests' effects on population health is substantial.

Conclusions:

• Reliable projection of MCED tests' clinical impact requires addressing critical knowledge gaps concerning cancer signal confirmation, screening strategies, and cancer biology.
• Informed expectations about MCED tests necessitate clear communication of current uncertainties to patients, providers, and regulatory bodies.
• A coordinated effort to collect data on MCED test implementation and outcomes is essential for rigorous evaluation of their benefit, harm, and cost.