# 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.

Source: https://en.bioecon.ru/companies/viome/
Updated: 2026-06-26

- Country: United States

## Verifiable facts

| Fact | Value | Source |
| --- | --- | --- |
| Capacity | 20,000+ samples per month (2026-06-01) | https://www.viomepro.com/%5F%5Fl5e/assets-v1/d1ab904c-d752-48c7-a681-40d1fa7c4835/Viome%5FClinical%5FOverview%5FV1.0%5FJune%5F2026.pdf |
| Certification | CLIA-certified laboratory (License 50D2224932) (2026-06-01) | https://www.viomepro.com/%5F%5Fl5e/assets-v1/d1ab904c-d752-48c7-a681-40d1fa7c4835/Viome%5FClinical%5FOverview%5FV1.0%5FJune%5F2026.pdf |
| Regulatory approval | FDA Breakthrough Device designation for oral and throat cancer detection test (2026-06-01) | https://www.fiercebiotech.com/medtech/viome-scores-fda-breakthrough-label-for-microbiome-sequencing-ai-platform-for-cancer, https://www.fiercehealthcare.com/health-tech/viome-life-sciences-unveils-home-oral-throat-cancer-detection-test, https://www.viome.com/blog/viome-oral-and-throat-cancer-detection-test-designated-breakthrough-device, https://www.viomepro.com/%5F%5Fl5e/assets-v1/d1ab904c-d752-48c7-a681-40d1fa7c4835/Viome%5FClinical%5FOverview%5FV1.0%5FJune%5F2026.pdf |
| Production site | Bothell, Washington (11724 NE 195th Street, Suite 101) (2026-06-01) | https://www.viomepro.com/%5F%5Fl5e/assets-v1/d1ab904c-d752-48c7-a681-40d1fa7c4835/Viome%5FClinical%5FOverview%5FV1.0%5FJune%5F2026.pdf |
| Revenue | $14.7M annual recurring revenue (ARR) (2024-12-31) | https://getlatka.com/companies/viome.com |

Independent sources: fiercebiotech.com, fiercehealthcare.com, getlatka.com

## Technologies

- [Microbiome diagnostic panels](https://en.bioecon.ru/technology/microbiome-diagnostic-panels/)
- [Personalized nutrition](https://en.bioecon.ru/technology/personalized-nutrition/)