The New England Journal of MedicineMulticancer Early Detection Tests — Keeping a High Bar for Evidence of Benefit

Multicancer Early Detection Tests: Balancing Promise and Evidence in Cancer Screening

Multicancer early detection (MCED) tests are emerging as a potential paradigm shift in cancer screening. These blood-based tests aim to detect multiple cancer types simultaneously, offering a simplified approach to screening. However, as Hilary A. Robbins, Ph.D., discusses in the New England Journal of Medicine, the implementation of MCED tests raises important questions about evidence standards and the need for rigorous evaluation of their benefits and potential harms.

Key Points:

• MCED tests measure blood-based biomarkers, including mutations, methylation, and fragmentation of cell-free DNA.
• These tests could potentially screen for dozens of cancer types, including those without current screening strategies.
• The NHS-Galleri study in England is conducting a randomized controlled trial (RCT) to assess the efficacy of an MCED test developed by GRAIL.
• The primary objective of the NHS-Galleri study is to demonstrate a reduction in stage III and IV cancer incidence rates.
• NHS England recently decided not to proceed with a planned rollout of the test to 1 million people in 2024, citing insufficiently compelling early results.
• Traditionally, cancer screening efficacy has been assessed through RCTs measuring cancer-specific mortality.
• Some proponents argue for faster RCT completion and against requiring cancer-specific mortality as an end point for initial approvals.
• Concerns exist about the ability of MCED tests to detect micrometastases that may not be apparent during standard staging.
• The US National Cancer Institute is planning an RCT that may evaluate multiple MCED tests and use cancer-specific mortality as an end point.
• The author argues for maintaining high evidence standards before implementing MCED testing.
• Current costs of MCED tests (up to $1000 per person) could strain healthcare systems.
• Companies are lobbying the US Congress to cover MCED tests in Medicare.
• The author emphasizes the importance of cautious implementation based on solid evidence of benefits and harms.

“If and when the lifesaving promise of MCED tests is shown to be a reality, it will be time for scientists, clinicians, policymakers, and the public to work together to ensure that multicancer early detection succeeds in practice.”
– Hilary A. Robbins, PhD; Genomic Epidemiology Branch, International Agency for Research on Cancer, World Health Organization, Lyon, France

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