Signatera by Natera

Test Performance

Key Features

Personalized cancer monitoring • Detects recurrence early • Treatment response tracking • Tumor-informed approach

Who It's For

Suited to: Cancer patients monitoring for recurrence

Not suited to: Initial cancer screening

This test is ordered by an oncologist after a cancer diagnosis. It is not a screening test for people without cancer. See the screening tests.

Important Notes

Not for initial detection - monitors known cancer patients for molecular residual disease. Tumor-informed, 64 clonal variants, ultra-deep sequencing to 350,000x. Medicare covered across colorectal, breast, bladder, lung, ovarian and pan-cancer ICI monitoring. The general MRD test is a CLIA laboratory-developed test, NOT FDA approved; only Signatera CDx holds FDA approval, as a companion diagnostic in muscle-invasive bladder cancer. CMS ADLT rate is $3,500 per assay per blood draw - this is a serial test, so annual cost depends on draw frequency.