Companies
Viome
Viome runs high-throughput RNA sequencing of the microbiome and holds an FDA Breakthrough Device designation for its saliva-based oral and throat cancer detection test, anchoring its clinical credibility.
- Country
- United States
Commercial
FDA Breakthrough Device
Coverage
| CN | EU | IN | US | |
|---|---|---|---|---|
| diagnostics-medtech | ✓ | ✓ | ✓ | ✓ |
| regenerative-personalized | ✓ | ✓ | — | ✓ |
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Verifiable facts
| Fact | Value | Source |
|---|---|---|
| Capacity | 20,000+ samples per month (2026-06-01) | viomepro.com |
| Certification | CLIA-certified laboratory (License 50D2224932) (2026-06-01) | viomepro.com |
| Regulatory approval | FDA Breakthrough Device designation for oral and throat cancer detection test (2026-06-01) | fiercebiotech.com · fiercehealthcare.com · viome.com · viomepro.com |
| Production site | Bothell, Washington (11724 NE 195th Street, Suite 101) (2026-06-01) | viomepro.com |
| Revenue | $14.7M annual recurring revenue (ARR) (2024-12-31) | getlatka.com |
Independent sources: fiercebiotech.com · fiercehealthcare.com · getlatka.com
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Microbiome diagnostic panels | diagnostics-medtech | Medium | → |
| Personalized nutrition | regenerative-personalized | Medium | → |
Compiled by BIOECON from primary sources.
Compliance
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