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 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.
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 pan-cancer genomic targets.5 Additionally, the Medicare MolDX LCD decision covers additional testing for patients progressing in their disease after initial treatment to help identify new therapeutic treatment options based on newly acquired tumor mutations.
Medicare’s expanded policy decision adds to Guardant360’s coverage by several private payers including Cigna, and multiple Blue Cross Blue Shield plans. Including Medicare, these plans cover the lives of more than 150 million people in the United States.
About Guardant Health
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360 and GuardantOMNI tests for advanced stage cancer patients and LUNAR assay for research use and for use in prospective clinical trials. In parallel, Guardant Health is actively exploring the performance of the LUNAR assay in initial studies related to screening and early detection in asymptomatic individuals.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the adoption of Guardant Health’s products, which involve risks and uncertainties that could cause Guardant Health’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the caption “Risk Factors” in Guardant Health’s Annual Report on Form 10-K for the year ended December 31, 2018, and in its other reports filed by Guardant Health with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.
In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Guardant Health.
Investor Contact:
Carrie Mendivil
Media Contact:
Anna Czene or Ian Stone
- Covers all solid tumor cancers except tumors primary to the central nervous system such as brain cancers.
- Hagemann IS, Devarakonda S,. Lockwood, CM et all. Clinical Next-Generation Sequencing in Patients with Non–Small Cell Lung Cancer. Cancer. 2015;121:631-9.
- Parsons HA, Beaver JA, Cimino-Mathews A et al. Individualized Molecular Analyses Guide Efforts (IMAGE): A Prospective Study of Molecular Profiling of Tissue and Blood in Metastatic Triple-Negative Breast Cancer. Cancer Res; 23(2); 379–86.
- Wyatt AW, Annala M, Aggarwal R et al. Concordance of Circulating Tumor DNA and Matched Metastatic Tissue Biopsy in Prostate Cancer. JNCI J Natl Cancer Inst (2018) 110(1): djx118
- Data on file, Guardant Health.
