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Guardant Health Liquid Biopsy Test Gets Draft LCD for Most Advanced Solid Tumors

NEW YORK (GenomeWeb) – Medicare contractor Palmetto GBA has proposed coverage for Guardant Health's 73-gene Guardant360 liquid biopsy test in more than a dozen solid tumor types where biomarker information is needed to inform their treatment.

In a draft local coverage decision issued today, Palmetto said it would cover Guardant360 for advanced solid tumors when tissue-based genomic analysis is not possible or when tissue testing for non-small cell lung cancer hasn't identified actionable mutations. Patients can be eligible for covered testing if they are considering treatment with drug with a biomarker-defined indication that is US Food and Drug Administration approved or is recommended by the National Comprehensive Cancer Network.

"In spite of the importance of actionable biomarker identification in cancer, research has shown that many patients do not receive genetic testing for the presence of actionable mutations in their cancers, and there are geographic disparities in testing with patients in rural areas and those receiving care at community treatment centers being less likely to receive testing," Palmetto said in the draft LCD, adding that difficulties obtaining sufficient tissue samples for analysis is another major hindrance to test access. 

This is the first liquid biopsy genomic profiling assay to receive broad local coverage across multiple solid tumors. Palmetto and other Medicare contractors previously granted local coverage to Guardant360 for patients with advanced non-small cell lung cancer. 

In moving to expand coverage of the test, Palmetto reasoned that broader access to a liquid biopsy assay may help address the limitations of biomarker-guided treatments informed by tissue-based profiling tests. "Even among patients whose cancers were genomically profiled at diagnosis and found to have a mutation for which they are receiving targeted treatment, resistance to the initial targeted treatment may emerge," Palmetto said. "For some patients, the identification of a new mutation, not present in the original tissue sample and found in the blood, may allow the selection of a new targeted life-prolonging therapy."

CMS a year ago granted national coverage for FDA-approved or -cleared NGS companion diagnostics for patients with advance solid tumors, and left if up to Medicare contractors to determine coverage when these types of tests are not FDA approved but performed in a CLIA certified lab. The NCD was triggered by Foundation Medicine's bid for parallel review from the FDA and CMS for its 324-gene tissue-based FoundationOne CDx. 

The terms of the latest draft LCD on Guardant360 align with the criteria outlined in the NCD. Members of the public can comment on this proposed coverage of this test from May 6 to June 20.