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.

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