Natera's Signatera MRD Assay Gains Medicare Coverage For Multiple Cancer Types

(RTTNews) - Natera, Inc. (NTRA), a leader in cell-free DNA and precision medicine, announced that its genome-based Signatera MRD assay has secured Medicare coverage under LCD L38779.

This coverage includes Medicare beneficiaries with colorectal, breast, bladder, ovarian, lung cancers, and pan-cancer immunotherapy monitoring, aligning with prior coverage for Signatera.

The Medicare decision is supported by strong evidence validating the assay's accuracy, backed by over 100 clinical studies. At the 2025 ASCO Annual Meeting, Natera presented a pan-cancer study involving 392 patients and 2,600+ samples using Signatera Genome, a recently launched assay for clinical and research use. The test employs patented multiplex PCR-NGS technology for deep sequencing of high-quality targeted variants.

Matthew Mega, Senior VP of Market Access, emphasized that Medicare coverage confirms the assay's clinical utility and validity, expanding access to innovative MRD testing for Medicare patients.

Matthew Mega highlighted the significance of Medicare coverage for the genome-based Signatera assay, noting it validates both the test's clinical utility and its analytical accuracy. He stated that this coverage enables broader patient access to Natera's advanced MRD testing innovations.

Wednesday, NTRA closed at $167.22, up 4.41%, and traded after hours at $167.02, down 0.12% on the Nasdaq Global Select Market.