Natera, Inc. announced that its genome-based Signatera molecular residual disease (MRD) assay is now covered by Medicare under LCD L38779. This coverage decision significantly expands access to Natera's latest innovation in cancer diagnostics.
The Medicare coverage applies to beneficiaries with colorectal cancer, breast cancer, bladder cancer, ovarian cancer, lung cancer, and for pan-cancer immunotherapy monitoring. This mirrors the pre-existing coverage for the standard Signatera test, ensuring broad applicability.
This coverage determination was supported by robust evidence on the validity of the genome-based assay, leveraging the extensive body of literature validating Signatera in over 100 published clinical studies. The expanded coverage allows Medicare patients broader access to the ultra-sensitive Signatera Genome assay.
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