A Medicare Pathway for Multi-Cancer Early Detection

The signing of the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act marks a meaningful shift in U.S. cancer screening policy. For the first time, Medicare has a defined benefit category and a clear pathway to evaluate and potentially cover multi-cancer early detection tests once they receive FDA approval.

This change matters because most cancer deaths occur in cancers that lack recommended screening today. While scientific advances have made earlier detection increasingly possible, policy frameworks have lagged behind. By establishing a dedicated pathway, the law gives Medicare the authority to consider MCED tests as preventive care, aligning public policy with emerging capabilities in early cancer detection while preserving rigorous standards for evidence and oversight.

At TOBY, we see this as an important step forward for the field. The law now formally establishes a Medicare pathway for multi-cancer early detection, while preserving the need for FDA approval and evidence-based CMS review. What remains is execution. How this pathway is implemented will determine the pace and scope of patient access, but the structural uncertainty that once constrained the field has now been removed by statute.

To learn more, visit Toby.health.

About TOBY, Inc.:

TOBY, inspired by Sherlock Holmes's Bloodhound, is a BioTech startup focused on the early detection of cancer utilizing spectroscopy and Artificial Intelligence. TOBY has developed a single urine test that detects 10 cancers, representing over 60% of all new cases globally. This test identifies the unique molecular signature of cancer by combining the precision of spectroscopy, changes in biomarkers (VOCs), and cutting-edge computational algorithms to deliver early, easy, and affordable cancer screening.

SOURCE TOBY, Inc.

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