Companies
Guardant Health
Guardant Health secured the first FDA-approved liquid biopsy for non-small cell lung cancer (NSCLC) profiling.
- Country
- United States
Coverage
| CN | EU | IN | US | |
|---|---|---|---|---|
| diagnostics-medtech | ✓ | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Verifiable facts
| Fact | Value | Source |
|---|---|---|
| Capacity | Accelerated investment in laboratory capacity ongoing as of 2026 to support volume growth | investors.guardanthealth.com · sdbj.com |
| Certification | CLIA certified, CAP accredited, and licensed in California, New York, and other states | sec.gov |
| Regulatory approval | FDA approval for Guardant360 Liquid CDx (May 2026), Guardant360 CDx (2020), and Shield blood test (2024) | investors.guardanthealth.com · sec.gov |
| Production site | Laboratories in Redwood City, California (HQ); San Diego, California; Long Island City, New York; and Palo Alto, California (CLIA licensed) | sdbj.com · sec.gov |
| Revenue | $982 million in 2025 | businesswire.com · medicaldevice-network.com |
Independent sources: businesswire.com · medicaldevice-network.com · sdbj.com · sec.gov
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Liquid biopsy & ctDNA diagnostics | diagnostics-medtech | Low | → |
| Personalized diagnostics | diagnostics-medtech | Low | → |
Compiled by BIOECON from primary sources.
Compliance
Bioecon is an information intermediary; it is not a regulator, a certification body, or a legal advisor. When working with public-sector customers (procurement under 44-FZ / 223-FZ), Bioecon acts solely as an independent analytical platform, with no remuneration from suppliers.