Companies
Natera
Signatera holds EU IVDR certification across multiple cancers, FDA companion-diagnostic approval in muscle-invasive bladder cancer, an NCCN-guideline recommendation for bladder-cancer ctDNA-MRD testing, and a broad clinical launch of the ultra-sensitive Signatera Genome MRD test.
- Country
- United States
- Ticker
- NTRA
Commercial
Signatera MRD / CDx
Coverage
| CN | EU | IN | US | |
|---|---|---|---|---|
| diagnostics-medtech | ✓ | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Verifiable facts
| Fact | Value | Source |
|---|---|---|
| Certification | Signatera holds EU IVDR Class C certification across multiple cancers | investor.natera.com · natera.com |
| Regulatory approval | FDA companion-diagnostic approval for Signatera in muscle-invasive bladder cancer | investor.natera.com · natera.com |
| Regulatory approval | PMDA approval in Japan for colorectal cancer | investor.natera.com · natera.com |
| Production site | Laboratories in Austin, Texas; San Carlos, California; and Boulder, Colorado (subsidiary) | natera.com |
| Capacity | Expansion in Austin designed to have the largest sequencing capacity in the world | natera.com |
| Revenue | $2,306.1 million in 2025 | sec.gov |
| Revenue | 2026 revenue guidance of $2.74 billion to $2.82 billion | investor.natera.com |
| Headcount | Expects to create up to 400 new jobs through Austin expansion | investor.natera.com · natera.com |
Independent sources: sec.gov
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Liquid biopsy & ctDNA diagnostics | diagnostics-medtech | Low | → |
Compiled by BIOECON from primary sources.
Compliance
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