Liquid biopsy focused precision oncology company Guardant Health announced Thrusday that Medicare Administrative Contractor for the Molecular Diagnostics program finalized an expanded local coverage determination (LCD) for its flagship Guardant360 assay, making it the first liquid biopsy cancer test gain coverage for use across the majority of advanced solid tumors. The MolDx LCD also covers additional testing for patients whose cancer has progressed after initial treatment to help identify new therapeutic treatment options based on newly acquired tumor mutations.
Guardant360 is an enabling technique that helps overcome the hurdle of not having enough tissue from a specific cancer for testing, or when an invasive biopsy may not be recommended. The LCD announced by Palmetto provide coverage under Medicare’s fee-for-service model for patient who meet clinical criteria for complete genomic profiling with next-generation sequencing of tumor tissue, but may not have access to such tissue.
“Unfortunately, too many patients today are not tested for the key guideline-recommended biomarkers needed to make targeted treatment decisions,” said Guardant Health CEO Helmy Eltoukhy, Ph.D., in a press release. “This is a critical issue, as response rates can be two to three times better using targeted therapies compared to chemotherapy and significantly higher than immunotherapy. Guardant360 fills the testing gap for patients who are unable to be completely tested using tissue biopsies.”
The expanded coverage for Guardant360 comes nearly nine months after Palmetto issued a draft LCD for the additional solid tumor cancers, which only excludes tumors of cancers of the central nervous system. The test had previously garnered an LCD from Palmetto and other MACs for its use for non-small cell lung cancer (NSCLC) in July 2018.
The expanded coverage decision follows FDA approvals of targeted or immunotherapies that are tumor-agnostic and based on a single genomic biomarker across all cancers. It is also in line with the approval of drugs targetable across multiple cancer types such as ERBB2 (HER2) amplification in breast, colorectal, gastric and uterine cancer, or BRAF V600E/K mutation in lung, colorectal, melanoma, and thyroid cancer. Guardant360 covers all of these multi- and pan-cancer genomic targets.
In addition to Medicare’s expanded coverage of Guardant360, it is also covered by a number of private payers including Cigna, and multiple Blue Cross Blue Shield plans. According to Guardant, along with Medicare, these heatlh plans cover the lives of more than 150 million people in the United States.