Signatera by Natera

Cancer patients monitoring for recurrence

Variable

CLIA LDT (CDx approved only for bladder cancer)

Detects: Patient-specific

Sample: Blood draw

Results: 3-4 weeks initial, 7-10 days per draw

Test Performance

Sensitivity

Varies by cancer

Specificity

PPV >98%

Detection Method

ctDNA (personalized)

Turnaround

3-4 weeks initial, 7-10 days per draw

Key Features

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

Who It's For

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.

Learn more about Signatera by Natera

Discuss with your physician before ordering.

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