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Guardant Health Receives Medicare Coverage for Tissue-Based Cancer Test

NEW YORK – Guardant Health announced on Tuesday that its Guardant360 TissueNext test for advanced cancer has received Medicare coverage.

The assay is covered under Medicare Administrative Contractor Palmetto GBA's local coverage determination for next-generation sequencing-based tests for solid tumors, which was originally released in February 2020. The tissue-based test is used to identify patients with advanced cancer who may benefit from biomarker-informed treatment. 

The LCD covers Guardant360 TissueNext for Medicare fee-for-service patients with advanced solid tumor cancers as a standalone service, according to a statement from the company.

Under the general LCD, tests are covered if the patient has recurrent, relapsed, refractory, metastatic, or advanced cancer; has not been previously tested by the same test for the same genetic content; and is seeking further treatment. The test must also include the minimum genes and genomic positions required to identify clinically relevant US Food and Drug Administration-approved therapies with a companion diagnostic biomarker, as well as other biomarkers known to be necessary for clinical decision making for its intended use that can reasonably be detected by the test.

If another comprehensive genomic profiling test was performed on the same tumor specimen, the Guardant test will not be covered.