Natera, Inc. announced that its Signatera test has met coverage requirements from the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostics Services Program (MolDX) for patients with non-small cell lung cancer (NSCLC). This coverage applies to stage I-III NSCLC patients with resectable or unresectable disease in the surveillance setting.
This expansion builds upon existing Medicare coverage for Signatera in monitoring immunotherapy, a common treatment for NSCLC. Lung cancer is the leading cause of cancer death in the U.S., with an estimated incidence of 226,650 and mortality of 124,730 in 2025.
Signatera’s performance and utility in NSCLC surveillance were validated in three independent peer-reviewed studies, demonstrating longitudinal sensitivity between 93-100% and specificity between 96-100%. The test also showed an observed lead time of up to one year ahead of imaging, with a median of five months, enabling earlier detection of recurrence.
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