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

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Multicancer early detection (MCED) tests show promise for identifying multiple cancers simultaneously. However, these tests lack FDA approval and clinical endorsement, necessitating careful discussion of risks and benefits with patients.

Keywords:
American Cancer SocietyUnited Stateshumansmass screeningneoplasms/diagnosis/prevention and control

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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.