Multicancer Detection Assays: Promise and Potential Harms of a Novel Cancer Screening Tool

Area of Science:

• Oncology
• Genomics
• Medical Diagnostics

Background:

• Multicancer detection (MCD) tests represent a significant advancement in cancer screening.
• These blood-based tests aim to identify multiple cancer types simultaneously, potentially improving early detection and accessibility compared to traditional methods.
• MCD tests show promise in enhancing screening for cancers with existing modalities and addressing gaps for those without.

Purpose of the Study:

• To evaluate the potential benefits and harms of emerging multicancer detection (MCD) tests.
• To explore the implications of MCD tests for cancer screening, healthcare resources, and patient equity.
• To identify essential components for the responsible integration of MCD tests into clinical practice.

Main Methods:

• Review of emerging multicancer detection (MCD) technologies and their performance characteristics.
• Analysis of potential benefits, including earlier cancer detection and broader screening applicability.
• Assessment of potential harms, such as false-positive/negative results, overdiagnosis, and healthcare system impacts.

Main Results:

• MCD tests demonstrate capability in detecting cancer signals and suggesting tissue of origin.
• Potential harms include emotional distress from false positives, false reassurance from false negatives, overdiagnosis of indolent cancers, and increased healthcare resource utilization.
• Concerns regarding unclear follow-up protocols, limited harms reporting, and equity issues due to trial underrepresentation persist.

Conclusions:

• Rigorous evaluation, transparent reporting of harms, and robust follow-up and shared decision-making protocols are essential for MCD tests to provide net benefit.
• Careful integration into existing screening practices is necessary to maximize benefits and minimize unintended consequences as MCD tests evolve.
• Addressing equity concerns and ensuring diverse representation in clinical trials are critical for equitable MCD test implementation.