
Screen time for Guardant
Guardant Health, first to market with a pan-cancer liquid biopsy, is also the first to launch a blood test to screen for colorectal cancer. The Shield assay, formerly called Lunar-2, went on sale yesterday in the US as a homebrew test to detect colorectal cancer in average-risk people aged 45 and older. Sales are unlikely to be stratospheric at first: the vast Eclipse trial, designed to support FDA approval of the test in this setting, has not yet reported – the data might come at Asco next month. Approval for Shield, should it be granted, ought to allow sales-boosting reimbursement and guideline changes, though guidelines are unlikely to be updated before 2026, according to Stifel analysts. At that point Shield would amount to a major threat to Exact Sciences’ Cologuard stool test, currently the leading non-invasive colorectal screen. In advance of the Eclipse readout, Guardant released new data from a smaller study indicating that Shield’s sensitivity and specificity for detecting cancer were 91% and 92% respectively – competitive with Cologuard and the clinical-stage second-gen version of that test. Guardant is also investigating Shield as a screen for lung, pancreatic and bladder cancers, but for now all the attention remains on Eclipse.
Guardant's liquid biopsies | ||||
---|---|---|---|---|
Company | Liquid biopsy | Intended use | Tumour type | Status |
Guardant Health | Guardant360 | Helps assign targeted therapy | Pan-cancer | Approved in US Aug 7, 2020, price approx $6,800 |
Reveal | Postsurgical, detects disease recurrence | Colorectal | Launched as LDT Feb 16, 2021 | |
Shield | Screening | Colorectal | Launched as LDT May 2, 2022, price TBD; pivotal Eclipse trial to report mid-2022 | |
Lung | Pivotal Shield trial to report 2024 | |||
Pancreatic | In development | |||
Bladder | In development | |||
LDT = lab-developed test. Source: Evaluate Medtech & company website. |