Guardant Health, Inc. (GH)

Guardant Health describes itself as a leading precision oncology company focused on giving every person more time free from cancer. It provides blood and tissue tests, real-world data and AI analytics that help reveal what drives disease. Its tests are used across all stages of care: screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for advanced cancer. Its products run on the proprietary Smart Platform, which combines methylation technology with genomic, epigenomic and RNA-based data, proprietary chemistry, advanced algorithms and the InfinityAI learning engine.

For advanced cancer, the company offers the Guardant360 CDx test, a 74-gene test that was the first comprehensive liquid biopsy approved by the FDA, with companion diagnostic claims in non-small cell lung, breast and colorectal cancers. It also offers the Guardant360 Liquid test (740+ genes) and the Guardant360 Tissue test, a multiomic tissue profiling test. The Guardant Reveal blood test detects residual disease and recurrence in early-stage colorectal, breast and lung cancer and now also monitors therapy response in late-stage solid tumors. For screening, the Shield blood test is the first FDA-approved blood test for primary colorectal cancer screening in average-risk adults 45 and older. It meets Medicare coverage requirements and is included in NCCN guidelines. The FDA has granted Breakthrough Device designation to the Shield MCD test, and the company plans to expand into lung cancer screening and multi-cancer detection. Biopharmaceutical offerings include the GuardantINFINITY and GuardantOMNI blood tests, the GuardantINFORM in-silico data platform for drug development, and GuardantConnect software that matches patients with clinical studies.

Customers are clinicians and biopharmaceutical companies. In the United States, a targeted sales organization focuses on oncologists, cancer centers, community oncology practices, academic institutions, primary care physicians, health systems and physician networks. A business development team sells to biopharmaceutical companies in the U.S. and abroad for target discovery, retrospective sample analysis, screening and referral for study enrollment, and companion diagnostic development. Outside the U.S., the company sells through insurers, hospitals, distributors and laboratory partnerships. It has a CE mark for Guardant360 CDx in the EU, partnerships with VHIO in Spain, Royal Marsden in the UK and Policlinico Gemelli in Italy, Japanese regulatory and reimbursement approval for Guardant360 CDx, and a partnership with Adicon in China. Revenue depends on payer coverage and reimbursement. Rates differ for participating and non-participating providers, and the company works with commercial and government payers to expand coverage.

The text does not identify suppliers, manufacturing arrangements, competitors or headquarters. It does describe a strategy of increasing awareness, expanding clinical evidence and reimbursement, strengthening customer relationships, and broadening the product portfolio. It also describes clinical study programs for Guardant360, Guardant Reveal and Shield, whose results are shared through peer-reviewed publications and scientific meetings.