The brief
- FDA approved Signatera as companion diagnostic for bladder cancer; Japan approved it for colorectal cancer.
- Signatera's Q2 2026 tests grew 56% YoY to 283,000; total company revenue $753M (+38% YoY).
- Full-year 2026 guidance raised to $2.85-2.91B. GALAXY trial shows MRD guides chemotherapy benefit.
Technical approach
Detecting tumor DNA in blood
Signatera measures circulating tumor DNA in blood by identifying patient-specific tumor mutations and tracking their reappearance in follow-up draws.
Residual disease guidance
After treatment, negative MRD results guide de-escalation; positive results suggest additional therapy. One test detects one cancer cell in 10,000 normal cells.
Deep sequencing
Targeted sequencing and proprietary algorithms find tumor mutations at extremely low sensitivity, personalized to each patient's cancer.

