Guardant Health Announces Medicare Coverage for the Guardant360 Assay in Non-Small Cell Lung Cancer

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Jul 12, 2018, 13:51 ET

REDWOOD CITY, Calif., July 12, 2018 /PRNewswire/ -- Guardant Health, Inc. announced that Palmetto GBA, a Medicare Administrative Contractor and leader in evaluating molecular diagnostic technology through its laboratory technology assessment group, MolDx, has finalized its local coverage determination for the Guardant360® assay, the market-leading comprehensive liquid biopsy. The policy covers Guardant360's comprehensive genomic profiling for all fee-for-service Medicare patients in the United States with metastatic non-small cell lung cancer who meet certain clinical criteria. It follows the recent publication of a validation of Guardant360 in Clinical Cancer Research that demonstrated that for treatment-relevant alterations in EGFR, ALK, ROS1, BRAF, MET, and KRAS, the positive concordance of Guardant360 to tissue genotyping of samples received for clinical testing at Guardant's laboratory was 92-100 percent.

Lung cancer guidelines increasingly call for broad molecular profiling to optimize treatment planning. However, the difficulty in acquiring lung tumor tissue often leads to incomplete testing. Because of this, various guidelines have endorsed the use of plasma-based tests for molecular profiling when tissue is not available.

"Now thanks to the leadership of Palmetto's MolDx program, Medicare beneficiaries with advanced lung cancer and their physicians have better access to less toxic, effective targeted therapies without the risk, pain, or expense of a further invasive tissue biopsy," said Helmy Eltoukhy, co-founder and CEO of Guardant Health.

A recent study showed that fewer than half of newly diagnosed advanced lung cancer patients receive testing for all recommended genomic markers¹, while an analysis of Medicare data found that the average lung biopsy costs Medicare more than $14,000, primarily because nearly one in five is associated with an adverse event².

"All patients deserve access to the optimal treatment," said Bonnie Addario, chair of the Bonnie J. Addario Lung Cancer Foundation. "This finalized coverage policy gives patients an important, non-invasive tool for getting the right treatment at the right time, both when an initial biopsy has insufficient tissue for complete molecular profiling and upon progression."

Since its introduction in 2014, the Guardant360 assay has been ordered more than 70,000 times to help inform which therapy may be effective for advanced stage cancer patients with solid tumors. It is supported by more than 70 peer-reviewed journal publications, which address its analytical validity, clinical validity, and clinical utility. Guardant360 is also covered by several private payers including Cigna, and several Blue Cross Blue Shield plans.

About Guardant Health, Inc.
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. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 and GuardantOMNI, for advanced stage cancer patients, which fuel its development programs for recurrence and early detection, LUNAR-1 and LUNAR-2, respectively. Since its launch in 2014, Guardant360 has become the world's market-leading comprehensive liquid biopsy test and has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network Centers. Learn more at www.guardanthealth.com.

1. Gutierrez et al. 2017 Clinical Lung Cancer
2. Lokhandwala et al. 2016 Clinical Lung Cancer

SOURCE Guardant Health