NEW YORK – Guardant Health said Wednesday that private health insurance firm UnitedHealthcare now covers the cost of the Guardant360 CDx assay for enrolled patients who fall under the test's US Food and Drug Administration-approved companion diagnostic indications. These include individuals with advanced lung and breast cancers.
Guardant360 CDx was approved by the FDA in 2020 for comprehensive genomic profiling of all solid tumors. The assay also has a growing slate of FDA-approved CDx indications, which currently includes four targeted therapies in non-small cell lung cancer and one in advanced breast cancer.
The test has been covered for Medicare beneficiaries, regardless of tumor type or CDx indication, since 2019.