Guardant Health, Inc. (GH)

Guardant Health is a precision oncology company that uses blood and tissue tests and real-world data to give insight into what drives cancer across all stages of care, from screening and early detection to recurrence monitoring and treatment selection in advanced disease. Its tests run on a digital sequencing technology that combines high-efficiency front-end biochemistry, next-generation sequencing and a machine learning augmented bioinformatics pipeline. For advanced-stage cancer, its main products are the Guardant360 LDT, which measures 80+ cancer-related genes, and Guardant360 CDx, a 55-gene test that the company believes was the first comprehensive liquid biopsy approved by the FDA.

Guardant360 CDx is approved as a companion diagnostic for non-small cell lung cancer and breast cancer therapies. The company also offers the Guardant360 TissueNext tissue test and the Guardant360 Response test, which tracks ctDNA levels to predict treatment response eight weeks earlier than standard imaging. For early-stage cancer, the Guardant Reveal blood test detects residual disease and recurrence in colorectal, breast and lung cancers.

For screening, the company launched the Shield LDT colorectal cancer blood test in May 2022 and submitted a premarket approval application to the FDA in March 2023 after the ECLIPSE registrational study met its co-primary endpoints. It is also developing a next-generation Shield assay for lung and multi-cancer screening, including the SHIELD LUNG study. For biopharmaceutical customers, it provides the GuardantOMNI 500-gene test and the GuardantINFINITY smart liquid biopsy assay, which covers more than 800 genes with methylation detection.

It also offers the GuardantINFORM real-world data platform, the GuardantConnect clinical study matching software, and the Guardant Galaxy suite of analytical technologies. Biopharmaceutical services include target and resistance discovery, retrospective sample analysis, patient screening for trial enrollment, and companion diagnostic development. In the United States, a targeted sales organization sells to oncologists, academic institutions, community oncology practices and cancer centers, and a business development team sells to biopharmaceutical companies in the U.S. and abroad.

Internationally, the company sells through insurers, hospitals, distributors and laboratory partnerships. It holds CE marks for Guardant360 CDx, Guardant360 LDT and Guardant Reveal. Its partners include VHIO in Spain, Royal Marsden in the UK and Adicon in China.

It has full control of Guardant AMEA, which covers Asia, the Middle East and Africa, and its Guardant360 CDx has regulatory approval and national reimbursement in Japan. Revenue depends on coverage and reimbursement from commercial and public payers, and the company works to expand coverage, clinical evidence, guideline inclusion and regulatory approvals.