Business Strategy and Outlook| Julie Utterback, CFA |
Guardant Health is taking a slightly different approach than liquid biopsy peers Illumina and Exact Sciences by initially targeting the early-stage detection and screening niche through individualized cancer tests. We expect Guardant will be a first mover in colorectal cancer liquid biopsy with the Lunar-2 test likely to be one of the first to obtain Food and Drug Administration approval, and we estimate the U.S. market opportunity at $18 billion for colorectal cancer screening alone, the initial focus of the test. We believe Guardant is ahead of peers in single-cancer screening, with the firm currently enrolling 10,000 people for its Eclipse clinical trial, which could lead to FDA approval within the next year or so if the full trial supports initial promising data. If this occurs, we would expect the company to rapidly pursue other indications, such as lung, breast, and ovarian cancer, and a possible combination multi-cancer test in the long run.