Multicancer early detection testing: Guidance for primary care discussions with patients.

Area of Science:

• Oncology
• Medical Diagnostics
• Public Health

Background:

• Multicancer early detection (MCED) tests represent a novel approach to cancer screening.
• These tests analyze biological samples for signals from multiple cancer types concurrently.
• Current MCED tests are commercially available but lack regulatory approval and clinical guidelines.

Purpose of the Study:

• To summarize the current evidence and issues surrounding MCED testing.
• To provide a framework for clinicians to discuss MCED testing with patients.
• To emphasize shared decision-making regarding cancer screening options.

Main Methods:

• Review of existing literature on MCED test performance, safety, and effectiveness.
• Analysis of the current regulatory and insurance landscape for MCED tests.
• Development of a communication strategy for clinicians regarding MCED testing.

Main Results:

• MCED tests are not yet evaluated in randomized controlled trials for safety and efficacy.
• No MCED tests are approved by the FDA or included in clinical practice guidelines.
• Clinicians need to be prepared to discuss the benefits, risks, and uncertainties of MCED testing with patients.

Conclusions:

• Clinicians should engage in shared decision-making with patients inquiring about MCED tests.
• MCED testing should not replace guideline-recommended cancer screenings.
• Further research and evaluation are needed to establish the role of MCED tests in cancer screening.