Guardant nudges up 2026 sales forecast as oncology and Shield testing grow

Guardant Health now expects to book between $1.36bn and $1.37bn in revenue this year. That is a tighter range than the $1.34bn-$1.36bn it had previously indicated: the bottom moves up by $20m and the top by $10m. The change came with results published on 5 November.

The US company reported $361.0m of revenue for the third quarter. It credited the result to higher testing volumes in its oncology business and to growing use of Shield, its blood-based screening test, whose cumulative test count reached 83,000.

Payer access for Shield is also widening. Guardant said coverage now extends to more than 80% of eligible lives, though the company did not detail in the material reviewed which plans or programmes make up that figure.

On the regulatory side, the US Food and Drug Administration approved Guardant360 CDx as a companion diagnostic for camizestrant. It also cleared the test as a companion diagnostic for imlunestrant used with abemaciclib in breast cancer with ESR1 mutations. Both approvals tie treatment selection to a specific liquid biopsy assay.

Guardant has also filed a premarket approval application for Guardant360 Tissue. PMA is the FDA's most stringent pathway for higher-risk devices and requires evidence of safety and effectiveness. The company did not give a decision timeline in the information available.