Natera's Lung Cancer Test Gains Medicare Coverage
San Francisco, Sunday, 2 March 2025.
Natera’s Signatera test receives MolDx coverage, enhancing surveillance of non-small cell lung cancer and potentially improving patient outcomes with high sensitivity and specificity.
Breakthrough in Cancer Surveillance
In a significant development for cancer care, Natera announced on March 1, 2025, that its Signatera test has secured Medicare coverage through the Molecular Diagnostics Services Program (MolDX) for patients with non-small cell lung cancer (NSCLC) [1]. This coverage expansion encompasses both resectable and unresectable disease in stages I-III, building upon its previous authorization for immunotherapy monitoring [1]. The timing is crucial, as lung cancer remains one of the deadliest forms of cancer, with projected statistics showing approximately 226,650 new cases and 124,730 deaths in 2025 [2].
Clinical Impact and Performance Metrics
The Signatera test has demonstrated remarkable clinical performance, with longitudinal sensitivity ranging from 93-100% for extracranial recurrence detection and specificity between 96-100% [2]. Notably, the test can detect cancer recurrence up to one year before conventional imaging methods [2]. This early detection capability is particularly significant given that NSCLC has a reported 5-year overall survival rate of just 28% [2].
Expanding Access to Precision Medicine
The Medicare coverage decision represents a significant step forward in democratizing access to advanced cancer monitoring tools. As Dr. Alexey Aleshin, Natera’s chief medical officer, notes, this coverage decision ‘expands access to Signatera for patients with the most lethal and one of the most common forms of cancer in the U.S.’ [2]. The test’s coverage now extends across multiple cancer types, including colorectal, muscle-invasive bladder, breast, and ovarian cancers, as well as pan-cancer immunotherapy response monitoring [2].