Clinical Implementation of Multi-Cancer Early Detection Tests: Can We Find a Path Forward?

Tibau A, Kesselheim AS - Nature Reviews Clinical Oncology

  • Regulation and Clinical Evidence

Summary:

The authors discuss the growing momentum behind multi-cancer early detection (MCED) blood tests, including the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, which creates a pathway to Medicare coverage to accelerate access once clinical benefit is confirmed. They argue, however, that MCED tests should be evaluated using the same rigorous standards expected of cancer screening programs, including randomized trials assessing mortality outcomes, before widespread adoption.

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How Congress Can Fix Expert Advisory Committees

Daval CJR, Kesselheim AS - STAT

  • Regulation and Clinical Evidence
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International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway

Mulsant SS, Kesselheim AS, Naci H - Journal of Cancer Policy

  • Price, Value, and Access
  • Regulation and Clinical Evidence
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Comments on FDA Discussion Paper, “Considerations for the Regulation of Generative AI-Enabled Medical Devices”

Jaiswal N, Gorijavolu R, Thomas S, Hwang TJ, Celi LA, Kesselheim AS - Food and Drug Administration (FDA)

  • Regulation and Clinical Evidence