GH: Does G360 FDA Approval Mean a 180 For Numbers? Modeling the Impact of Potential ASP Uplift

Research evidence excerpt

GH: Does G360 FDA Approval Mean a 180 For Numbers? Modeling the Impact of Potential ASP Uplift

Life Science Tools & Diagnostics

Specialty Diagnostics - Market Overweight

GH: Does G360 FDA Approval Mean a 180 For Numbers? June 16, 2026

Modeling the Impact of Potential ASP Uplift

The Wolfe Byte

FDA approval of G360 Liquid CDx sets stage for a potential price uplift via the ADLT pathway. Impact? Meaningful

tailwind to G360 revenue not yet in model. If realized, we see incremental 15 and 30 points of revenue growth in

2027 and 2028.

Guardant recently earned FDA approval for its Guardant360 CDx expanded panel liquid biopsy therapy selection

test. The G360 Liquid test represents roughly ~60% of total GH revenue. This FDA approval is a good guy for both

volume and price, neither of which are considered in the company-issued long-range plan that calls for 30% revenue

growth through 2028.

Why a good guy for volume? Previously there were two versions of the G360 Liquid test that a doc could order –

(1) Guardant360 CDx on a smaller panel (74 genes), with FDA approval enabling reimbursement under the National

Coverage Determination (NCD) for Next Generation Sequencing (NGS) 90.2, or (2) the G360 laboratory developed

test (LDT) with a larger gene panel (~740 genes) but no FDA approval, meaning this version reimbursed via the Local

Coverage Determination (LCD) for plasma based genomic profiling. I.e., a pro and con to each test. Now? All the pros in

one test – the comprehensive panel test now reimbursed through NCD 90.2. Less friction/options/confusion in ordering

and reimbursement process = easier to access and should encourage more doc ordering. Also an added bonus on volume

– this update likely to increase pull through of Guardant360 Tissue tests.