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Guardant Health Receives Expanded Medicare Coverage for Guardant360 Across the Vast Majority of Solid Tumor Cancers
REDWOOD CITY, Calif., Dec. 19, 2019 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (Nasdaq: GH), announced that Palmetto GBA, a Medicare Administrative Contractor
About this update from Guardant Health, Inc.
[{"type":"text","content":"REDWOOD CITY, Calif., Dec. 19, 2019 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (Nasdaq: GH), announced that Palmetto GBA, a Medicare Administrative Contractor for the Molecular Diagnostics (MolDX) program, has expanded local coverage determination (LCD) of the Guardant360® assay, making it the first and only liquid biopsy to be broadly covered for use across the vast majority of advanced solid tumors.1 This decision makes complete genomic profiling more widely available for patients with most advanced cancers.\n The policy covers Guardant360 for all fee-for-service Medicare patients with advanced cancers who meet its clinical criteria for complete genomic profiling with next-generation sequencing (NGS) of tumor tissue to optimize treatment selection decisions but have insufficient or unavailable tissue for molecular profiling. Tissue insufficiency has been shown to be a significant hurdle to wider adoption of precision oncology. It is estimated that as many as 30 percent of advanced cancer patients are not biopsiable or have insufficient biopsy material for tissue testing.2-4 “Unfortunately, too many patients today are not tested for the key guideline-recommended biomarkers needed to make targeted treatment decisions. 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,” said Guardant Health CEO Helmy Eltoukhy, PhD. “Guardant360 fills the testing gap for patients who are unable to be completely tested using tissue biopsies. This expanded coverage decision across most advanced solid tumor cancers, validates the growing body of evidence showing the clinical utility of using Guardant360 to optimize treatment decisions and demonstrates a commitment to advancing precision oncology.” The expanded coverage decision is in line with FDA approvals of targeted or immunotherapies that are tumor-agnostic and based on a single genomic biomarker across all cancers, such as targeted therapy for NTRK fusions and microsatellite instability (MSI), and is also in line with approvals 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 p...